- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01925274
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Madrid, Espanha, 28009
- Hospital General Universitario Gregorio Marañon
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California
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Bakersfield, California, Estados Unidos, 93309
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
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Los Angeles, California, Estados Unidos, 90095-7349
- UCLA West Medical Pharmacy
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Los Angeles, California, Estados Unidos, 90095
- Regulatory Management Only: TRIO-US Central Administration
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Los Angeles, California, Estados Unidos, 90095-7349
- Drug Management Only: UCLA West Medical Pharmacy
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Los Angeles, California, Estados Unidos, 90095
- TRIO_US
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Los Angeles, California, Estados Unidos, 90095-7349
- Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D
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Los Angeles, California, Estados Unidos, 90095
- TRIO-US Central Administration (Regulatory Management only)
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Northridge, California, Estados Unidos, 91328
- West Valley Hematology/Oncology Med Group
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Missouri
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Creve Coeur, Missouri, Estados Unidos, 63141
- Siteman Cancer Center - West County
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Estados Unidos, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, Estados Unidos, 63129
- Siteman Cancer Center - South County
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Saint Peters, Missouri, Estados Unidos, 63376
- Siteman Cancer Center - St Peters
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Nevada
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Henderson, Nevada, Estados Unidos, 89074
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Estados Unidos, 89052
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Estados Unidos, 89014
- Regulatory Office: Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
- Comprehensive Cancer Centers of Nevada
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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Washington
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Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinic Hematology and Oncology
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Richland, Washington, Estados Unidos, 99352
- Kadlec Medical Center
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Richland, Washington, Estados Unidos, 99352
- Outpatient Imaging Center
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Spokane, Washington, Estados Unidos, 99208
- Medical Oncology Associates, PS
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Spokane Valley, Washington, Estados Unidos, 99216
- Spokane Valley Cancer Center
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Aichi
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Nagoya, Aichi, Japão, 464-8681
- Aichi cancer center central hospital
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Chiba
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Kashiwa, Chiba, Japão, 277-8577
- National Cancer Center Hospital East
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Seoul, Republica da Coréia, 135-710
- Samsung Medical Center
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Seoul, Republica da Coréia, 138-736
- Asan Medical Center
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Seoul, Republica da Coréia, 110-744
- Seoul National University Hospital / Department of Internal Medicine
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Republica da Coréia, 410-769
- National Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- KRAS and NRAS wild type metastatic colorectal cancer
- Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
- Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
- At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
Exclusion Criteria:
- More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
- Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
- Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
- Prior radiation to the pelvis or abdomen
- Patients with history of interstitial lung disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Arm A
PF-05212384 plus Irinotecan
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30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle.
Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.
Outros nomes:
90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle
Outros nomes:
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Comparador Ativo: Arm B
Cetuximab plus Irinotecan
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120 minute IV infusion of cetuximab 400mg/m^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1
Outros nomes:
90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression Free Survival (PFS) as Assessed by Investigators
Prazo: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.
Median PFS was estimated based on the Kaplan-Meier method.
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From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)
Prazo: 28 days
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Unacceptable toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) was any of the following occurrences: (1) Grade 4 neutropenia >7 days, or febrile neutropenia, or Grade 4 thrombocytopenia; (2) Grade >=3 nausea/vomiting despite optimal antiemetic treatment, or Grade >=3 diarrhea despite optimal anti diarrheal treatment; (3) unmanageable Grade >=3 hyperglycemia; (4) mean QTc interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate) >501 msec in triplicate 12-lead ECG, or myocardial infarction, or ventricular arrhythmia; (5) Grade >=3 non-hematologic toxicity; (6) treatment delay of >=2 weeks due to study drug related toxicity; (7) persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses of both PF-05212384 and irinotecan during Cycle 1; (8) Grade >=2 respiratory toxicities.
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28 days
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Percentage of Participants With Objective Response
Prazo: 2 years
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Percentage of participants with objective response was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1.
Confirmed PR was defined as disappearance of all target lesions.
Confirmed PR was defined as >=30% decrease in sum of the longest dimensions of the target lesions taking the baseline sum as a reference.
Confirmed responses were those that persisted on repeat imaging study >=4 weeks after initial documentation of response.
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2 years
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Duration of Response
Prazo: 2 years
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For participants with an objective response (CR or PR), duration of response was defined as the time from first documentation of CR or PR to date of first documentation of objective progression or death.
Date of first documentation of progression and date of first documentation of CR or PR were based on Investigator's assessment of response.
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2 years
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Overall Survival (OS)
Prazo: 2 years
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Overall survival (OS) was defined as the duration from enrollment to death.
Participants last known to be alive were censored at date of last contact.
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2 years
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Prazo: Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
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An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
An SAE was defined as any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
AEs included both serious and non-serious AEs.
Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.
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Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Prazo: Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
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TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
CTCAE version 4.0 was used to grade the severity of TEAEs.
Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.
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Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
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Number of Participants With Laboratory Test (Hematology) Abnormalities
Prazo: 2 years
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The following hematology parameters were evaluated in this study: hemoglobin, white blood cells (WBC) with differential, and platelets.
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2 years
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Number of Participants With Laboratory Test (Chemistry) Abnormalities
Prazo: 2 years
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The following chemistry parameters were evaluated in this study: sodium, potassium, magnesium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, albumin, blood urea nitrogen (BUN) or urea, creatinine, total calcium, glycosylated hemoglobin (HbA1c), glucose, uric acid, phosphorus or phosphate, insulin, and C-peptide.
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2 years
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Number of Participants With Laboratory Test (Urinalysis) Abnormalities
Prazo: 2 years
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Urinalysis included urine dipstick for protein and blood: if positive, perform a microscopic analysis.
Number of participants with urine protein tested positive is presented.
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2 years
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Number of Participants With Laboratory Test (Coagulation) Abnormalities
Prazo: 2 years
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Coagulation analysis included partial thromboplastin time (PTT) and international normalized ratio (INR) or prothrombin time (PT).
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2 years
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Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria
Prazo: 2 years
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The number of participants with ECG post-baseline maximum absolute values meeting the following criteria was reported: (1) maximum QTc interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (2) maximum QTcB (QT corrected for heart rate using Bazett's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (3) maximum QTcF (QT corrected for heart rate using Fridericia's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec.
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2 years
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Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria
Prazo: 2 years
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The number of participants with ECG maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum QTc interval increase from baseline >30 msec and ≤60 msec; criterion B: maximum QTc interval increase from baseline >60 msec; criterion C: maximum QTcB interval increase from baseline >30 msec and ≤60 msec; criterion D: maximum QTcB interval increase from baseline >60 msec; criterion E: maximum QTcF interval increase from baseline >30 msec and ≤60 msec; criterion F: maximum QTcF interval increase from baseline >60 msec. |
2 years
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Maximum Plasma Concentration (Cmax) of PF-05212384
Prazo: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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Cmax of PF-05212384 was observed directly from data.
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Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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Maximum Plasma Concentration (Cmax) of Irinotecan
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Cmax of irinotecan was observed directly from data.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Maximum Plasma Concentration (Cmax) of SN-38
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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SN-38 is an irinotecan metabolite.
Cmax of SN-38 was observed directly from data.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Time for Maximum Plasma Concentration (Tmax) of PF-05212384
Prazo: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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Tmax of PF-05212384 was observed directly from data as time of first occurrence.
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Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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Time for Maximum Plasma Concentration (Tmax) of Irinotecan
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Tmax of irinotecan was observed directly from data as time of first occurrence.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Time for Maximum Plasma Concentration (Tmax) of SN-38
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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SN-38 is an irinotecan metabolite.
Tmax of SN-38 was observed directly from data as time of first occurrence.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Terminal Elimination Half Life (t½) of PF-05212384
Prazo: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
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Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
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Terminal Elimination Half Life (t½) of Irinotecan
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Terminal Elimination Half Life (t½) of SN-38
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384
Prazo: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
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AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration.
AUClast of PF-05212384 was determined using linear/log trapezoidal method.
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Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
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Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration.
AUClast of irinotecan was determined using linear/log trapezoidal method.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration.
AUClast of SN-38 (an irinotecan metabolite) was determined using linear/log trapezoidal method.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384
Prazo: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
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AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time.
AUCinf of PF-05212384 was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
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Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
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Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time.
AUCinf of irinotecan was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38
Prazo: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time.
AUCinf of SN-38 (an irinotecan metabolite) was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
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Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
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Levels of Signaling Proteins in Paired and Single Tumor Biopsies
Prazo: 2 years
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Pre defined signaling proteins included Akt (protein kinase B), p-Akt (phosphorylated Akt), p-S6 (phosphorylated ribosomal protein S6), p-Met (phosphorylated Met, a receptor tyrosine kinase), p-mTOR (phosphorylated mammalian target of rapamycin), EGFR (epithelial growth factor receptor), and p-EGFR (phosphorylated EGFR).
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2 years
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Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues
Prazo: 2 years
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Pre-defined gene sequences were those related to EGFR, PI3K (phosphoinositide-3 kinase) and other oncogenic pathways; examples included but were not limited to PIK3CA (this gene encodes the catalytic subunit of PI3K), PIK3R1 (this gene encodes the regulatory subunit of PI3K), KRAS, NRAS and BRAF (this gene encodes serine/threonine-protein kinase B-Raf) sequences and PIK3CA gene amplification.
Due to early termination of this study, these pre-defined gene sequences were not analyzed, except for KRAS and NRAS.
Number of participants who had KRAS and NRAS wild type status confirmed by the central laboratory is presented.
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2 years
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Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Prazo: 2 years
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Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used in this study to assess Health-Related Quality of Life (HRQoL) and CRC-related symptoms in participants enrolled to the randomized portion of the study.
The FACT-C is part of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system, a comprehensive and extensive set of self-reported instruments for the assessment of health-related quality of life in participants with cancer or other chronic illnesses.
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2 years
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias
- Neoplasias por local
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Doenças Intestinais
- Neoplasias Intestinais
- Doenças retais
- Neoplasias Colorretais
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores da Topoisomerase
- Agentes Antineoplásicos Imunológicos
- Inibidores de proteína quinase
- Inibidores da Topoisomerase I
- Irinotecano
- Cetuximabe
- Gedatolisibe
Outros números de identificação do estudo
- B2151005
- 2013-002095-40 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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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