A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Advanced Solid Tumors
Conditions: Keywords
PARP, Ovarian cancer, BRCA, veliparib, Breast cancer, ABT-888, Fallopian tube, Primary peritoneal cancer
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: veliparib (ABT-888)
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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.
Site Reference ID/Investigator# 128056
Hidaka-shi, Japan
Status: Recruiting
Site Reference ID/Investigator# 129976
Hyogo, Japan
Status: Recruiting
Site Reference ID/Investigator# 128057
Tokyo, Japan
Status: Recruiting
Start Date
July 2014
Completion Date
September 2016
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page