Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
27 de janeiro de 2021 atualizado por: Novartis Pharmaceuticals
A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This was a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO (International Federation of Gynecology and Obstetrics) Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that had not progressed (i.e., complete response (CR), partial response (PR), stable disease (SD) after completing their first-line chemotherapy for advanced ovarian cancer.
Approximately 900 subjects were to be enrolled into the study.
Study was closed following 3rd overall survival (OS) interim analysis as planned per protocol, which confirmed futility.
Tipo de estudo
Intervencional
Inscrição (Real)
940
Estágio
- Fase 3
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Piemonte
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Torino, Piemonte, Itália, 10126
- Novartis Investigative Site
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Torino, Piemonte, Itália, 10128
- Novartis Investigative Site
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Puglia
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Bari, Puglia, Itália, 70124
- Novartis Investigative Site
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Sicilia
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Palermo, Sicilia, Itália, 90146
- Novartis Investigative Site
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Umbria
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Perugia, Umbria, Itália, 06132
- Novartis Investigative Site
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Veneto
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Vicenza, Veneto, Itália, 36100
- Novartis Investigative Site
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Ehime, Japão, 791-0280
- Novartis Investigative Site
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Fukuoka, Japão, 811-1395
- Novartis Investigative Site
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Hiroshima, Japão, 734-8551
- Novartis Investigative Site
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Hiroshima, Japão, 737-0023
- Novartis Investigative Site
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Hokkaido, Japão, 060-8648
- Novartis Investigative Site
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Iwate, Japão, 020-8505
- Novartis Investigative Site
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Kagoshima, Japão, 890-8760
- Novartis Investigative Site
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Miyagi, Japão, 980-8574
- Novartis Investigative Site
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Osaka, Japão, 589-8511
- Novartis Investigative Site
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Saitama, Japão, 350-1298
- Novartis Investigative Site
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Tokyo, Japão, 104-0045
- Novartis Investigative Site
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Tokyo, Japão, 160-8582
- Novartis Investigative Site
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Tokyo, Japão, 105-8471
- Novartis Investigative Site
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Tokyo, Japão, 125-8506
- Novartis Investigative Site
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Tottori, Japão, 683-8504
- Novartis Investigative Site
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Bergen, Noruega, 5021
- Novartis Investigative Site
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Oslo, Noruega, 0310
- Novartis Investigative Site
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Stavanger, Noruega, 4011
- Novartis Investigative Site
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Tromso, Noruega, 9038
- Novartis Investigative Site
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Goyang-si, Gyeonggi-do, Republica da Coréia, 410-769
- Novartis Investigative Site
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Kangnam-Ku ,Seoul, Republica da Coréia, (135-702)
- Novartis Investigative Site
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Seoul, Republica da Coréia, 03080
- Novartis Investigative Site
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Seoul, Republica da Coréia, 138-736
- Novartis Investigative Site
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Seoul, Republica da Coréia, 135-710
- Novartis Investigative Site
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Linkoping, Suécia, SE-581 85
- Novartis Investigative Site
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Lund, Suécia, SE-221 85
- Novartis Investigative Site
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Stockholm, Suécia, SE-171 76
- Novartis Investigative Site
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Uppsala, Suécia, SE-751 85
- Novartis Investigative Site
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Taipei, Taiwan, 104
- Novartis Investigative Site
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Taipei, Taiwan, 112
- Novartis Investigative Site
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Graz, Áustria, A-8036
- Novartis Investigative Site
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Graz, Áustria, 8020
- Novartis Investigative Site
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Innsbruck, Áustria, 6020
- Novartis Investigative Site
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Klagenfurt Am Woerthersee, Áustria, 9020
- Novartis Investigative Site
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Korneuburg, Áustria, 2100
- Novartis Investigative Site
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Krems, Áustria, 3500
- Novartis Investigative Site
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Leoben, Áustria, 8700
- Novartis Investigative Site
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Linz, Áustria, 4020
- Novartis Investigative Site
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Linz, Áustria, 4010
- Novartis Investigative Site
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Oberpullendorf, Áustria, 7350
- Novartis Investigative Site
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Wien, Áustria, 1090
- Novartis Investigative Site
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Wien, Áustria, 1130
- Novartis Investigative Site
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Wien, Áustria, 1160
- Novartis Investigative Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- written informed consent
- At least 18 years old.
- Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
- Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
- No evidence of disease progression
- ECOG status of 0 or 2
- Able to swallow and retain oral medication.
- Adequate hematologic, hepatic, and renal system function as follows:
Hematologic
- Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
- Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
- Platelets at least 100 X 10^9/L
- Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
- Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
- Total bilirubin up to 1.5 X ULN
- AST and ALT up to 2.5 X ULN Renal
- Serum creatinine up to 1.5 mg/dL
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance at least 50 mL/min Urine Protein
- Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis.
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.
Exclusion Criteria:
- Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
- Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) > 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
- Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Hemoptysis within 6 weeks prior to randomization.
- Endobronchial metastases.
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Investigational or anti-VEGF anticancer therapy prior to study randomization.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
- Invasive malignancies that showed activity of disease within 5 years prior to randomization
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Placebo
matched placebo tablet administered orally once daily for up to 24 months
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Matching placebo 800 mg tablet daily, for 104 weeks (24 months).
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Experimental: Pazopanib
Pazopanib tablet administered orally at 800 mg once daily for up to 24 months
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Pazopanib 800 mg tablet daily for 104 weeks (24 months)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Investigator-assessed Progression-free Survival (PFS)
Prazo: From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
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PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause.
Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions.
For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs.
Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA).
Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT.
Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.
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From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival - Median
Prazo: From the date of randomization until the date of death due to any cause up to approximately 25 months
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Overall surival is defined as the interval between the date of randomization and the date of death due to any cause.
For participants who did not die, the time to death was censored at the time of last contact.
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From the date of randomization until the date of death due to any cause up to approximately 25 months
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Overall Survival: Number of Participants Experiencing Death
Prazo: From the date of randomization until the date of death due to any cause up to approximately 25 months
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Overall surival is defined as the interval between the date of randomization and the date of death due to any cause.
For participants who did not die, the time to death was censored at the time of last contact.
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From the date of randomization until the date of death due to any cause up to approximately 25 months
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Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
Prazo: From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
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Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause.
Progression is defined according to RECIST but can also be based upon serum CA-125.
Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par.
with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par.
with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.
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From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
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3-year Progression-free Survival
Prazo: Up to 3 years after randomization
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3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization.
Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause.
Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
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Up to 3 years after randomization
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Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life.
Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent").
Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?"
Data are transformed to a scale ranging from 0 to 100.
Higher scores represent better functioning (better quality of life).
Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses attitude to disease/treatment functional symptoms, among others.
Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health?
Data are transformed to a scale ranging from 0 to 100.
Higher scores represent better functioning (better quality of life).
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses body image symptoms, among others.
Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?;
Have you been dissatisfied with your body?
Data are transformed to a scale ranging from 0 to 100.
Higher scores represent better functioning (better quality of life).
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses peripheral neuropathy symptoms, among others.
Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs?
Data are transformed to a scale from 0 to 100.
Lower scores represent better health (fewer symptoms) for symptom scales.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses AB/GI symptoms, among others.
Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?;
Did you experience any change in bowel habit as a result of your disease or treatment?;
Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn?
Data are transformed to a scale from 0 to 100.
Lower scores represent better health (fewer symptoms) for symptom scales.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses hormonal/menopausal symptoms, among others.
Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats?
Data are transformed to a scale from 0 to 100.
Lower scores represent better health (fewer symptoms) for symptom scales.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses sexual functioning symptoms, among others.
Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?;
If sexually active, to what extent was sex enjoyable for you?;
If sexually active, did you have a dry vagina during sexual activity?
Higher scores represent better functioning (better quality of life).
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Data were not analyzed due to low compliance (<50% at Baseline).
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer.
It assesses other chemotherapy SE symptoms, among others.
Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment.
Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?;
If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)?
Data are transformed to a scale from 0 to 100.
Lower scores represent better health (fewer symptoms) for symptom scales.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Data were not analyzed due to low compliance (<50% at Baseline).
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS.
The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale.
For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46.
A negative adjusted mean change from Baseline represents a worsening of quality of life.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25
Prazo: Baseline; Week 13; Months 7, 10, 13, 16, and 25
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The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression.
Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem.
Unique health states were defined by combining response levels from each of the five dimensions.
For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression.
Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health).
A negative adjusted mean change from Baseline represents a worsening of quality of life.
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
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Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm
Prazo: From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade refers to the severity of the AE.
The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
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From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade
Prazo: From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade refers to the severity of the toxicity.
The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.
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From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade
Prazo: From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade refers to the severity of the toxicity.
The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.
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From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)
Prazo: From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Participants were assessed for thyroid function abnormalities.
Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).
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From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.
- Vergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10.
- Friedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796.
- Pulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63. doi: 10.1186/s12910-016-0144-y.
- Floquet A, Vergote I, Colombo N, Fiane B, Monk BJ, Reinthaller A, Calvert P, Herzog TJ, Meier W, Kim JW, del Campo JM, Friedlander M, Pisano C, Isonishi S, Crescenzo RJ, Barrett C, Wang K, Mitrica I, du Bois A. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015 Jan;136(1):37-42. doi: 10.1016/j.ygyno.2014.11.074. Epub 2014 Nov 28.
- du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. doi: 10.1200/JCO.2014.55.7348. Epub 2014 Sep 15.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de maio de 2009
Conclusão Primária (Real)
8 de julho de 2012
Conclusão do estudo (Real)
24 de agosto de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
19 de março de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de março de 2009
Primeira postagem (Estimativa)
20 de março de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de fevereiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 110655
- 2008-004672-50 (Número EudraCT)
- CPZP034C2301 (Outro identificador: Novartis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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