Status:
COMPLETED
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
20-99 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02210663
Start Date
July 1 2014
End Date
July 1 2016
Last Update
May 7 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 128056
Hidaka-shi, Japan
2
Site Reference ID/Investigator# 129976
Hyōgo, Japan
3
Site Reference ID/Investigator# 128057
Tokyo, Japan