A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Veliparib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Life expectancy of greater than 12 weeks.

• Adequate organ and marrow function· Measurable or non-measurable disease.

Exclusion Criteria:

• Major surgery and/or radiation within (<) 4 weeks prior to study enrollment.

• Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.

• Any investigational agents within (<) 4 weeks prior to study enrollment.

• Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.

• Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.