Clinical trial NCT02210663: A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Official title: A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Breast cancer
PARP
Primary peritoneal cancer
Fallopian tube
Ovarian cancer
veliparib
ABT-888
BRCA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Dose-limiting toxicities of veliparib
timeFrame: During the first cycle (28 days) of veliparib administration
Secondary outcomes:
measure: Change in participant physical exam measurements
timeFrame: Approximately 1 year
measure: Change in participant clinical lab results
timeFrame: Approximately 1 year
measure: Number of participants with adverse events
timeFrame: Approximately 1 year
measure: Preliminary tumor response
timeFrame: Participants will be followed for the duration of an expected average of 8 months.
measure: Maximum observed plasma concentration (Cmax)
timeFrame: For 24 hours following veliparib dosing.
measure: The time to Cmax (peak time, Tmax)
timeFrame: For 24 hours following veliparib dosing.
measure: The area under the plasma concentration-time curve (AUC)
timeFrame: For 24 hours following veliparib dosing.
Other outcomes:
Locations:
city: Hidaka-shi
country: Japan
facility: Site Reference ID/Investigator# 128056
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 129976
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 128057
Study officials:
affiliation: AbbVie
name: Hideyuki Hashiba, BS
role: STUDY_DIRECTOR
References:
citation: Nishikawa 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.