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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: veliparib (ABT-888)

• Registration Number: NCT02210663
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Primary Completion: 2016-01
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
veliparib (ABT-888)	veliparib (ABT-888)	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities of veliparib	During the first cycle (28 days) of veliparib administration

Secondary Outcome Measures

Name	Time	Method
Change in participant physical exam measurements	Approximately 1 year	Blood pressure, pulse and body temperature
Change in participant clinical lab results	Approximately 1 year	Hematology, Chemistry and Urinalysis
Number of participants with adverse events	Approximately 1 year	Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Preliminary tumor response	Participants will be followed for the duration of an expected average of 8 months.	According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Maximum observed plasma concentration (Cmax)	For 24 hours following veliparib dosing.	Maximum observed concentration, occurring at Tmax
The time to Cmax (peak time, Tmax)	For 24 hours following veliparib dosing.	The time at which maximum plasma concentration (Cmax) is observed.
The area under the plasma concentration-time curve (AUC)	For 24 hours following veliparib dosing.

Trial Locations

Locations (3)

Site Reference ID/Investigator# 128056; 🇯🇵 Hidaka-shi, Japan

Site Reference ID/Investigator# 128057; 🇯🇵 Tokyo, Japan

Site Reference ID/Investigator# 129976; 🇯🇵 Hyogo, Japan