Phase II ABT-888 With Cyclophosphamide

Completed · Phase 2

Conditions studied: Ovarian Cancer, Primary Peritoneal Cancer, Serous Carcinoma Cancer, Triple-Negative Breast Cancer, Fallopian Tube Cancer

In brief

Background: \- The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment drug that works by causing DNA damage in cells, including cancer cells, resulting in cell death. However, because cyclophosphamide has strong and unpleasant side effects, researchers are interested in finding drugs that can be given in combination with cyclophosphamide that will allow a lower dose of cyclophosphamide to be given with similar effects. The combination of ABT-88 and cyclophosphamide may be an effective treatment for some types of cancer, such as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that often do not respond to standard therapies. Objectives: \- To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2) BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian tube cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy); or (3) low grade non-Hodgkin's lymphoma. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. Participants will be divided into two groups with different treatment subgroups. * Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or ovarian high-grade serous carcinoma, or fallopian tube cancer * Participants will receive either the combination of ABT-888 and cyclophosphamide, or cyclophosphamide alone. * Participants will take the study drug by mouth once a day for 21-day cycles of treatment, and will keep a diary to record drug doses and any side effects. * Participants will have clinic visits with blood and urine tests, imaging studies, and other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other cycles. * Group 2: Participants who have triple-negative breast cancer or non-Hodgkin's lymphoma * Participants will receive either the combination of ABT-888 and cyclophosphamide, or cyclophosphamide alone. * Participants will take the study drug by mouth once a day for 21-day cycles of treatment, and will keep a diary to record drug doses and any side effects. * Participants will have clinic visits with blood and urine tests, imaging studies, and other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other cycles. * Participants receiving only cyclophosphamide who show signs of disease progression after tumor imaging studies can receive the combination of ABT-888 with cyclophosphamide. * Treatment will continue as long as participants tolerate the drugs and the disease does not progress.

Key facts

Study ID: NCT01306032
Run by: National Cancer Institute (NCI)
People needed: 124
Starts: 2011-01-12
Expected to finish: 2016-12-15
Last updated by the study team: 2017-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Women who are pregnant or breastfeeding.
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with germ cell and borderline ovarian epithelial tumors.
Patients who have received prior cyclophosphamide should not be excluded solely because of receiving prior cyclophosphamide.
Patients with history of central nervous system (CNS) metastases who have received treatment and who have been on stable doses of anti-seizure medicine and had no seizures x 3 months will be eligible.
Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease) are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded, as are any patients who cannot swallow the capsule whole. Capsules must not be crushed or chewed; nasogastric or gastrostomy tube (G-tube) administration is not allowed.
INCLUSION OF WOMEN AND MINORITIES:
Men and women of all races and ethnic groups are eligible for this trial.

Where it is running

University of California, Davis — Davis, California, United States
H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
University of Chicago — Chicago, Illinois, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Mayo Clinic, Rochester — Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Ohio State University — Columbus, Ohio, United States
MD Anderson Cancer Center — Houston, Texas, United States
Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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