An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.

Abbott2 sites in 1 country24 target enrollmentJuly 2010

ConditionsSolid Tumor Cancers

Interventionsveliparib Temozolomide

Drugsveliparib Temozolomide

Overview

Phase: Phase 2
Intervention: veliparib
Conditions: Solid Tumor Cancers
Sponsor: Abbott
Enrollment: 24
Locations: 2
Primary Endpoint: To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

November 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Arm A

Intervention: veliparib

Arm A

Intervention: Temozolomide

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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.)