Clinical trial · Interventional
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
NCT02210663CI-TRIAL-00032810completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| veliparib (ABT-888) | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- veliparib (ABT-888)
- interventionNames
- Drug: veliparib (ABT-888)
Primary outcomes (1)
- measure
- Dose-limiting toxicities of veliparib
- timeFrame
- During the first cycle (28 days) of veliparib administration
Secondary outcomes (7)
- measure
- Change in participant physical exam measurements
- timeFrame
- Approximately 1 year
- description
- Blood pressure, pulse and body temperature
- measure
- Change in participant clinical lab results
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTNishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5. PMID 28665051