To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors

Phase 2

Completed

• Conditions: Solid Tumor Cancers
• Interventions: Drug: veliparib; Drug: Temozolomide

• Registration Number: NCT01193140
• Lead Sponsor: Abbott

Brief Summary

To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.

Detailed Description

An extension study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-16
• Disposition First Submitted QC: 2012-11-16
• Last Update Submitted: 2012-11-16
• Disposition First Posted: 2012-11-21
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	veliparib	-
Arm A	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors	Continuous starting with Day1 and 30 Days following last dose.	Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments

Secondary Outcome Measures

Name	Time	Method
To assess effect of veliparib/TMZ combination regimen on progression free survival, overall survival, the objective response rate, time to progression and Eastern Cooperative Oncology Group (ECOG) performance status in subjects with solid tumors	Every 12 weeks from Day1 and continuing up to 18 months following last dose.

Trial Locations

Locations (2)

Site Reference ID/Investigator# 42662; 🇺🇸 Santa Monica, California, United States

Site Reference ID/Investigator# 43022; 🇺🇸 Encinitas, California, United States