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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01113957




Registration number
NCT01113957
Ethics application status
Date submitted
26/02/2010
Date registered
30/04/2010
Date last updated
6/06/2018

Titles & IDs
Public title
A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer
Scientific title
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
Secondary ID [1] 0 0
2009-015082-31
Secondary ID [2] 0 0
M10-757
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-888
Treatment: Drugs - pegylated liposomal doxorubicin
Treatment: Drugs - temozolomide

Experimental: Arm A - ABT-888 in combination with temozolomide

Active comparator: Arm B - pegylated liposomal doxorubicin alone


Treatment: Drugs: ABT-888
Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally

Treatment: Drugs: pegylated liposomal doxorubicin
Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously.

Treatment: Drugs: temozolomide
Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate between the two treatment arms (ABT-888 + temozolomide versus the PLD) will be based on tumor measurements and CA-125 levels.
Timepoint [1] 0 0
Screening to survival follow-up (every 3 months for 3 years)
Secondary outcome [1] 0 0
Evaluate progression free survival, time to progression, overall survival, 12-month survival rate, 6-month progression free survival rate, duration of response
Timepoint [1] 0 0
Screening to survival follow-up (every 3 months for 3 years)
Secondary outcome [2] 0 0
Safety Assessments and tolerability (i.e. ECG, clinical laboratory tests, vital signs, AE assessments, physical exams, CT scans). See section 5 for detailed information.
Timepoint [2] 0 0
Screening to the 30 day follow-up visit
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Screening to survival follow-up (every 3 months for 3 years).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 25128 - Adelaide
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 25130 - Bedford Park
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 25131 - East Melbourne
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 25133 - Nedlands
Recruitment hospital [5] 0 0
Site Reference ID/Investigator# 25132 - Randwick
Recruitment hospital [6] 0 0
Site Reference ID/Investigator# 25129 - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Edmonton
Country [11] 0 0
Canada
State/province [11] 0 0
Kelowna
Country [12] 0 0
Canada
State/province [12] 0 0
Laval
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Israel
State/province [14] 0 0
Haifa
Country [15] 0 0
Israel
State/province [15] 0 0
Tel Aviv
Country [16] 0 0
Israel
State/province [16] 0 0
Tel Hashomer
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Poland
State/province [18] 0 0
Warsaw
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Northwood
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01113957
Trial related presentations / publications
Elit L, Hirte H. Palliative systemic therapy for women with recurrent epithelial ovarian cancer: current options. Onco Targets Ther. 2013;6:107-18. doi: 10.2147/OTT.S30238. Epub 2013 Feb 26.
Public notes

Contacts
Principal investigator
Name 0 0
Mark D McKee, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01113957