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Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer

Phase I Study of ABT-888, PARP Inhibitor, and Pegylated Liposomal Doxorubicin (PLD) in Recurrent Gynecologic Cancer and Breast Cancer

NCT01145430•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after a period of improvement, or breast cancer that has spread to other parts of the body. 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, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with liposomal doxorubicin hydrochloride may kill more tumor cells.

Detailed Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of recurrent or residual epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, OR histologically confirmed metastatic breast cancer, that is estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)/neu negative (as determined by local pathology laboratory)
•Prior chemotherapy:
•* Breast cancer: patients may have received 0-2 prior chemotherapy regimens for metastatic disease; breast cancer patients may not have received prior PLD, and will not be eligible for the expanded cohort A
•* Interval between prior chemotherapy and registration for breast and ovarian cancer; there should be at least a 3 week interval between the last chemotherapy regimen and registration, and the patient should have recovered from acute toxicity related to prior therapy (6 weeks if the last regiment included BCNU or mitomycin C)
•* Dose escalating cohorts only: patients will be categorized in the following strata based upon prior PLD exposure: Stratum A -patients with ovarian cancer who have had prior PLD exposure and received at least 3 cycles of PLD without prohibitive (i.e. no grade 3 or 4 skin toxicity) and have not had progressive disease; Stratum B: patients with ovarian or breast cancer who have had no prior PLD exposure
•Eastern Cooperative Oncology Group (ECOG) performance score 0-2
•All potential subjects should be evaluated for whether breast cancer (BRCA)1-2 testing is medically appropriate; individuals who have a 10% or higher risk of having a BRCA1-2 mutation (Myriad tables at www.myriad.com) are encouraged (but not required) to have mutation testing and results known; information regarding mutation status (positive \[including specific mutation\], negative, or unknown) and projected risk of having a mutation (as determined by Myriad tables) will be collected at the time of diagnosis
•Non-measurable and/or measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or abnormal cancer antigen (CA)-125 to levels (in patients with ovarian cancer) at least 1.5 x normal documented by two independent measurements at least 4 weeks apart
•Ability to give voluntary informed consent and to comply with treatment and required tests
•Ability to tolerate oral medications
+8 more criteria

Exclusion Criteria

•Known central nervous system (CNS) metastases with active symptoms, or requiring anticonvulsive medications, or steroids
•Prior chemotherapy (except PLD in Dose Escalation Cohorts only) or any investigational agent within 3 weeks prior to registration
•Prior radiation therapy to whole pelvis or greater amount of marrow-forming bone
•Prior or current non-gynecologic or non-breast malignancy within 5 years except non-melanoma skin cancer
•Patients with active severe infection; known infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, or severe concurrent illness
•Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the patient on protocol
•Patients with history of seizure disorder requiring antiepileptics who have had a seizure episode within the last 6 months
•Pregnant (positive pregnancy test) or lactating; unwillingness to use effective means of contraception in subjects with child-bearing potential
•Evidence of complete or partial bowel obstruction or other unable to take oral medications

Locations (6)

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Columbia University/Herbert Irving Cancer Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

May 23, 2017

Last Updated

December 22, 2017

Enrollment

ACTUAL participants

Conditions

Estrogen Receptor NegativeHER2/Neu NegativeMale Breast CarcinomaProgesterone Receptor NegativeRecurrent Breast CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaStage IV Breast Cancer AJCC v6 and v7Triple-Negative Breast Carcinoma

Interventions

Laboratory Biomarker Analysis

OTHER

Pegylated Liposomal Doxorubicin Hydrochloride

DRUG

Pharmacological Study

OTHER

Veliparib

DRUG

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

NCT03723928

Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor Positive+4 more

View study

RECRUITINGPHASE2

Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer

NCT03213041

Estrogen Receptor NegativeEstrogen Receptor Positive+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

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