Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01145430|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Negative HER2/Neu 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 AJCC v6 and v7 Triple-Negative Breast Carcinoma||Other: Laboratory Biomarker Analysis Drug: Pegylated Liposomal Doxorubicin Hydrochloride Other: Pharmacological Study Drug: Veliparib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of ABT-888, PARP Inhibitor, and Pegylated Liposomal Doxorubicin (PLD) in Recurrent Gynecologic Cancer and Breast Cancer|
|Actual Study Start Date :||June 1, 2010|
|Actual Primary Completion Date :||May 23, 2017|
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
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Other: Pharmacological Study
- 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 ]
- 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 ]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 ]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 ]Will be assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Laura and Isaac Perlmutter Cancer Center at NYU Langone|
|New York, New York, United States, 10016|
|Mount Sinai Hospital|
|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|