Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer
This phase I trial is studying the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride in patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer or metastatic breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with liposomal doxorubicin hydrochloride may kill more tumor cells.
Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Male Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Stage IV Breast Cancer
Triple-negative Breast Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE I STUDY OF ABT-888, PARP INHIBITOR, AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN RECURRENT GYNECOLOGIC CANCER AND BREAST CANCER|
- Recommended Phase II dose, based on incidence of DLT graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
- Progression-free survival (PFS) [ Time Frame: Time from first treatment day until objective or symptomatic progression, assessed up to 3 years ] [ Designated as safety issue: No ]Will be assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
- Overall survival (OS) [ Time Frame: Time from first treatment day until death or until last follow-up, assessed up to 3 years ] [ Designated as safety issue: No ]Will be assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
- Frequency of subjects experiencing toxicities in each stratum, assessed and graded according to terminology in the CTEP Version 4.0 of the CTCAE [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Will be tabulated. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (veliparib and liposomal doxorubicin hydrochloride)
Patients receive veliparib PO twice daily on days 1-14 and pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: ABT-888Drug: pegylated liposomal doxorubicin hydrochloride
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
I. To determine the recommended Phase II dose of ABT-888 (veliparib) given in combination with pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (PLD - 40 mg/m2 every 4 weeks) in patients with ovarian or breast cancer.
I. To determine the toxicity profile of the ABT-888 plus PLD combination. II. To determine the effects of ABT-888 on the pharmacokinetics of PLD. III. To determine the efficacy of ABT-888 plus PLD in ovarian and breast cancer.
OUTLINE: This is a multicenter, dose-escalation study of veliparib. Patients are stratified according to prior pegylated liposomal doxorubicin hydrochloride (yes vs no).
Patients receive veliparib orally (PO) twice daily on days 1-14 and pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected during courses 1-3 for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.
|United States, New York|
|Montefiore Medical Center-Weiler Division||Suspended|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467-2490|
|Contact: Joseph A. Sparano 718-904-2555 email@example.com|
|Principal Investigator: Joseph A. Sparano|
|Columbia University Medical Center||Suspended|
|New York, New York, United States, 10032|
|Mount Sinai Medical Center||Recruiting|
|New York, New York, United States, 10029|
|Contact: George Raptis 212-241-2298 firstname.lastname@example.org|
|Principal Investigator: George Raptis|
|New York University Langone Medical Center||Suspended|
|New York, New York, United States, 10016|
|Weill Medical College of Cornell University||Suspended|
|New York, New York, United States, 10065|
|Principal Investigator:||Bhavana Pothuri||Montefiore Medical Center|