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Protocol No. NCI9782

Principal Investigator Wisinski, Kari

Phase I

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed; Institutional

Title A Phase 1 Study of Talazoparib (BMN 673) in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors

Objective The purpose of this study is to test the safety of the study drug BMN 673 at different doses in combination with carboplatin and paclitaxel to find out what effects, if any, this combination has on people.

Treatment The study drug BMN 673 has not been fully tested in people and is not FDA-approved. Carboplatin and paclitaxel have been FDA approved to treat certain cancers. Everyone in this study will receive the same chemotherapy drugs, but some may receive different doses of the study drug BMN 673 in combination with carboplatin and paclitaxel or take BMN 673 on different dosing schedules.

Description For this study, there are two dosing schedules (A and B), which differ in the number of days that you take the study drug, BMN 673 in every cycle. The cycles are 21 days long. If you are on Schedule A, you will take BMN 673 by mouth every day for the first 7 days of every cycle. If you are on Schedule B, you will take BMN 673 by mouth every day for the first 3 days of every cycle. For both schedules, you will receive IV (in the vein) carboplatin on Day 1 of each cycle and IV paclitaxel on Days 1, 8, and 15. You will receive the study drug, BMN 673, along with carboplatin and paclitaxel for 4-6 cycles. You will be given a medication diary to record when you take BMN 673 at home.

Key Eligibility
  • Patients must have histologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable
  • Patients must have measurable disease
  • Patients with central nervous system metastases are eligible if stable after therapy for at least 4 weeks and off steroid treatment for for 2 weeks
  • Patients with ovarian cancer are eligible if more than 6 months have elapsed since last carboplatin dose

Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Kidney; Leukemia; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Testicular; Thyroid; Uterus; Vagina; Vulva

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved BMN 673; PF-06944076; MDV3800 (Talazoparib); Talazoparib; carboplatin; cbdca (carboplatin); paclitaxel; paraplatin (carboplatin); taxol (paclitaxel)

Status Open

Participating Institutions UW Hospital and Clinics