Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer
Estrogen Receptor Negative
Male Breast Carcinoma
Progesterone Receptor Negative
Recurrent Breast Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma
Other: Laboratory Biomarker Analysis
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Other: Pharmacological Study
|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 of veliparib, based on incidence of dose limiting toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
- Frequency of subjects experiencing toxicities in each stratum, assessed and graded according to terminology in the Cancer Therapy Evaluation Program (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.
- Overall survival [ 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.
- Progression-free survival [ 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.
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (veliparib and liposomal doxorubicin hydrochloride)
Patients receive veliparib PO BID 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: Laboratory Biomarker Analysis
Correlative studiesDrug: Pegylated Liposomal Doxorubicin Hydrochloride
Other Names:Other: Pharmacological Study
Correlative studiesDrug: Veliparib
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 dose-escalation study of veliparib.
Patients receive veliparib orally (PO) twice daily (BID) 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.
After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145430
|United States, New York|
|Montefiore Medical Center-Einstein Campus|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467-2490|
|New York University Clinical Cancer Center|
|New York, New York, United States, 10016-4760|
|Laura and Isaac Perlmutter Cancer Center at NYU Langone|
|New York, New York, United States, 10016|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Columbia University/Herbert Irving Cancer Center|
|New York, New York, United States, 10032|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|Principal Investigator:||Bhavana Pothuri||Montefiore Medical Center - Moses Campus|