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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: veliparib (ABT-888)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02210663

M14-489

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20 to 99 years old

Volunteers

No Healthy Volunteers

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.