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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210663
• Other study ID #: M14-489
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• veliparib (ABT-888)
Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 128056	Hidaka-shi
Japan	Site Reference ID/Investigator# 129976	Hyogo
Japan	Site Reference ID/Investigator# 128057	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities of veliparib		During the first cycle (28 days) of veliparib administration
Secondary	Change in participant physical exam measurements	Blood pressure, pulse and body temperature	Approximately 1 year
Secondary	Change in participant clinical lab results	Hematology, Chemistry and Urinalysis	Approximately 1 year
Secondary	Number of participants with adverse events	Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03	Approximately 1 year
Secondary	Preliminary tumor response	According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1	Participants will be followed for the duration of an expected average of 8 months.
Secondary	Maximum observed plasma concentration (Cmax)	Maximum observed concentration, occurring at Tmax	For 24 hours following veliparib dosing.
Secondary	The time to Cmax (peak time, Tmax)	The time at which maximum plasma concentration (Cmax) is observed.	For 24 hours following veliparib dosing.
Secondary	The area under the plasma concentration-time curve (AUC)		For 24 hours following veliparib dosing.