- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01113957
A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer
June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)
A Phase 2 Randomized Clinical Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects With Recurrent High Grade Serous Ovarian Cancer
The purpose of this study is to determine the objective response rate of ABT-888 when given in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in subjects with recurrent high grade serous ovarian cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Safety assessments and tolerability will be assessed through electrocardiograms (ECG).
clinical laboratory tests, vital signs, Adverse Event assessments, and physical exams.
Baseline radiographic tumor assessments, including CT scans of the chest, abdomen and pelvis will be obtained.
Radiologic assessments and CA-125 measurements will also be performed every 8 weeks during dosing and following completion of dosing until disease progression.
Study visits will be conducted weekly for the first 2 cycles and on Day 1 of each subsequent cycle, at the Final Visit and 30 day Follow-up Visit.
Study visits will include physical examination, complete blood count (CBC) and chemistries.
A urinalysis tests will be performed at Screening and Final Visit.
An ECG will be performed at Screening, Cycle 1 Day 1 and at the Final Study Visit.
A left ventricular ejection fraction (LVEF) will be measured by Echocardiogram or Multiple Gated Acquisition (MUGA) scan on all subjects at Screening.
Subjects randomized to the PLD arm will have an echocardiogram or MUGA performed at the Final Study Visit and at the discretion of the Investigator throughout the study.
Adverse events will be assessed at every visit.
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia, 5000
- Site Reference ID/Investigator# 25128
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Bedford Park, Australia, 5042
- Site Reference ID/Investigator# 25130
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East Melbourne, Australia, 3002
- Site Reference ID/Investigator# 25131
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Nedlands, Australia, 6009
- Site Reference ID/Investigator# 25133
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Randwick, Australia, 2031
- Site Reference ID/Investigator# 25132
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Westmead, Australia, 2145
- Site Reference ID/Investigator# 25129
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Edmonton, Canada, T6G 1Z2
- Site Reference ID/Investigator# 25166
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Kelowna, Canada, V1Y 5L3
- Site Reference ID/Investigator# 25162
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Laval, Canada, H7M 3L9
- Site Reference ID/Investigator# 25165
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Budapest, Hungary, H-1125
- Site Reference ID/Investigator# 25135
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Haifa, Israel, 31096
- Site Reference ID/Investigator# 25138
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Tel Aviv, Israel, 64239
- Site Reference ID/Investigator# 25139
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Tel Hashomer, Israel, 52621
- Site Reference ID/Investigator# 25141
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Auckland, New Zealand, 1023
- Site Reference ID/Investigator# 25402
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Warsaw, Poland, 02-781
- Site Reference ID/Investigator# 25145
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Northwood, United Kingdom, HA6 2RN
- Site Reference ID/Investigator# 25149
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Oxford, United Kingdom, OX3 7LJ
- Site Reference ID/Investigator# 25154
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California
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Duarte, California, United States, 91010
- Site Reference ID/Investigator# 25028
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Encino, California, United States, 91436
- Site Reference ID/Investigator# 25024
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Los Angeles, California, United States, 90048
- Site Reference ID/Investigator# 25034
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Newport Beach, California, United States, 92663
- Site Reference ID/Investigator# 25037
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Illinois
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Chicago, Illinois, United States, 60637-1470
- Site Reference ID/Investigator# 25030
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Park Ridge, Illinois, United States, 60068
- Site Reference ID/Investigator# 27837
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Peoria, Illinois, United States, 61615-7828
- Site Reference ID/Investigator# 25039
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- Site Reference ID/Investigator# 25038
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New York
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New York, New York, United States, 10065
- Site Reference ID/Investigator# 25023
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7570
- Site Reference ID/Investigator# 25041
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Ohio
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Hilliard, Ohio, United States, 43026
- Site Reference ID/Investigator# 25029
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Site Reference ID/Investigator# 25543
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Site Reference ID/Investigator# 25036
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Pittsburgh, Pennsylvania, United States, 15213
- Site Reference ID/Investigator# 25042
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Texas
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Houston, Texas, United States, 77030
- Site Reference ID/Investigator# 25027
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subject must have histologically (or cytologically) confirmed recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
- Subjects must have had at least 1 platinum containing chemotherapy regimen and no more than a total of 3 DNA damaging or cytotoxic regimens in the last 5 years. Less than a full dose of a DNA damaging agent, possibly due to reasons such as toxicity or documented allergic reaction are allowed. Previous treatments with biologics (including catumaxomab, tigatuzumab, abagovomab, and bevacizumab), vaccines, immunostimulants, hormonal agents, and signal transduction inhibitors (e.g., pazopanib, sorafenib, sunitinib, temsirolimus) are allowed and are not counted towards the limit of 3.
- Subjects who are resistant to platinum-based therapy; or sensitive to but are unable to tolerate platinum-based therapy (i.e., deemed toxic or have a documented platinum allergy). Subjects must have at least a > 3 month treatment free interval from the last dose of platinum based therapy.
- Subject must be eligible for PLD treatment.
Subject has either:
- Measurable disease, defined as at least 1 unidimensionally measurable lesion on a computed tomography (CT) scan as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 OR
- Non-measurable disease with an elevation of serum CA-125 level by Gynecologic Cancer Intergroup (GCIG) criteria (baseline sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
Subject must have adequate hematologic, renal and hepatic function as follows:
- Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 x 109/L); Platelets ≥ 100,000/mm3 (100 x 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L);
- Renal function: Serum creatinine ≤ 1.5 x upper normal limit of institution's normal range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal;
- Hepatic function: Aspartate aminotransferase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x the upper normal limit of institution's normal range. For subjects with liver metastases, AST and/or ALT < 5 x the upper normal limit of institution's normal range; Bilirubin ≤ 1.5 x the upper normal limit of institution's normal range;
- Partial thromboplastin time (PTT) must be ≤ 1.5 x the upper normal limit of institution's normal range and international normalized ratio (INR) < 1.5. Subjects on anticoagulant (such as Coumadin) are allowed on study and will have PTT and INR as determined by the Investigator
- Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and a negative urine pregnancy test on Cycle 1 Day 1. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria:
- Subject has previously received a poly-ADP-ribose)-polymerase (PARP) inhibitor except a single dose from Cancer Therapy Evaluation Program (CTEP) Phase 0 (A06-161) study.
- Subjects who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin hydrocloride (HCL) or the components of PLD.
- The subject has received an anticancer agents or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
- Subject has undergone major surgery within the previous 28 days prior to study drug administration.
- Subjects with prior radiotherapy to any portion of the abdominal cavity and pelvis, unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer. Subject must have completed radiation at least 28 days prior to study drug administration and have measurable disease outside the radiation field or documented progression of lesions within a previously radiated field.
- Subjects with a known history of brain metastases.
Clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Active uncontrolled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris or cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- Any medical condition, which is in the opinion of the Study Investigator, places the subject at an unacceptably high risk for toxicities
- Subject is pregnant or lactating.
- Subjects who requires parenteral nutrition, or tube feeding or has evidence of partial bowel obstruction or perforation.
- The subject has had another active malignancy within the past five years except for any cancer in situ considered cured or non-melanoma carcinoma of the skin. Questions regarding the inclusion of individual subject should be directed to the Abbott Medical Monitor.
- Subject has previously received a poly-ADP-ribose)-polymerase (PARP) inhibitor except a single dose from Cancer Therapy Evaluation Program (CTEP) Phase 0 (A06-161) study. - Subjects who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin hydrocloride (HCL) or the components of PLD.
- The subject has received an anticancer agents or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
- Subject has undergone major surgery within the previous 28 days prior to study drug administration.
- Subjects with prior radiotherapy to any portion of the abdominal cavity and pelvis, unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer. Subject must have completed radiation at least 28 days prior to study drug administration and have measurable disease outside the radiation field or documented progression of lesions within a previously radiated field.
- Subjects with a known history of brain metastases.
Clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Active uncontrolled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris or cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- Any medical condition, which is in the opinion of the Study Investigator, places the subject at an unacceptably high risk for toxicities
- Subject is pregnant or lactating.
- Subjects who requires parenteral nutrition, or tube feeding or has evidence of partial bowel obstruction or perforation.
- The subject has had another active malignancy within the past five years except for any cancer in situ considered cured or non-melanoma carcinoma of the skin. Questions regarding the inclusion of individual subject should be directed to the Abbott Medical Monitor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
ABT-888 in combination with temozolomide
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Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally
Other Names:
Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888
Other Names:
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Active Comparator: Arm B
pegylated liposomal doxorubicin alone
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Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Objective response rate between the two treatment arms (ABT-888 + temozolomide versus the PLD) will be based on tumor measurements and CA-125 levels.
Time Frame: Screening to survival follow-up (every 3 months for 3 years)
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Screening to survival follow-up (every 3 months for 3 years)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluate progression free survival, time to progression, overall survival, 12-month survival rate, 6-month progression free survival rate, duration of response
Time Frame: Screening to survival follow-up (every 3 months for 3 years)
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Screening to survival follow-up (every 3 months for 3 years)
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Safety Assessments and tolerability (i.e. ECG, clinical laboratory tests, vital signs, AE assessments, physical exams, CT scans). See section 5 for detailed information.
Time Frame: Screening to the 30 day follow-up visit
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Screening to the 30 day follow-up visit
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Evaluate Quality of Life and performance status will be done through the use of FACT-O quality of fife questionnaire, EQ5D questionnaire and ECOG performance status.
Time Frame: Screening to survival follow-up (every 3 months for 3 years).
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Screening to survival follow-up (every 3 months for 3 years).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark D McKee, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
February 26, 2010
First Submitted That Met QC Criteria
April 29, 2010
First Posted (Estimate)
April 30, 2010
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 1, 2018
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Poly(ADP-ribose) Polymerase Inhibitors
- Antibiotics, Antineoplastic
- Temozolomide
- Doxorubicin
- Liposomal doxorubicin
- Veliparib
Other Study ID Numbers
- M10-757
- 2009-015082-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
Clinical Trials on ABT-888
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AbbVieCompletedAdvanced Solid TumorsJapan
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National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Breast Carcinoma | Ovarian Carcinoma | Pancreatic Carcinoma | Prostate Carcinoma | Recurrent Breast Carcinoma | Estrogen Receptor Negative | HER2/Neu Negative | Progesterone Receptor Negative | Triple-Negative... and other conditionsUnited States
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National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | Ovarian Epithelial TumorUnited States
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AbbVie (prior sponsor, Abbott)Prostate Cancer Clinical Trials ConsortiumCompleted
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National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid NeoplasmUnited States
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Peritoneal Carcinomatosis | Adult Solid NeoplasmUnited States, Canada
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Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI); AbbVieUnknownUnresectable Solid Neoplasm | Recurrent Solid Neoplasm | Refractory Mantle Cell Lymphoma | Aggressive Non-Hodgkin Lymphoma | Advanced Solid Neoplasm | T-Cell Non-Hodgkin LymphomaUnited States
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Georgetown UniversityAbbottUnknownMetastatic Pancreatic CancerUnited States
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AbbVieNo longer availableHigh Grade Serous Ovarian Cancer | Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound | Triple Negative Breast Cancer (TNBC) | Patients Requiring Veliparib Suspension Formulation