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veliparib

Phase 2

Solid Tumor Cancers | Small molecule | Oncology |Abbott Laboratories|Last Updated: Nov 21, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

veliparib · 1 trial · 1 indication

Phase 2 1
NCT01193140To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid TumorsSolid Tumor Cancers
COMPLETED24 Analytics
PHASE2COMPLETED
To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors
Solid Tumor CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -

Interventions

NameTypeDescription
veliparibDRUGDose orally twice daily for 7 days, consecutively, every cycle
TemozolomideDRUGDose orally once daily for 5 days, consecutively, every cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria 1. Subject has completed study participation in Study M11-846 2. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. 3. Subject must have adequate hematologic, renal and hepatic function per institutional normal range as follows: • Bone Marrow: Absolute neutrop...

Countries:United States
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Frequently asked questions about veliparib

What is veliparib used for?

Veliparib is an investigational small molecule being studied for the treatment of solid tumor cancers. It is being evaluated in combination with temozolomide in patients with solid tumors. The drug is currently in Phase 2 clinical development and is not yet approved for any use.

What does veliparib target?

Veliparib is a small molecule being studied in oncology. The specific molecular target of veliparib has not been disclosed in the available information. It is being evaluated in combination with temozolomide for the treatment of solid tumor cancers.

Who makes veliparib?

Veliparib is being developed by Abbott Laboratories, which trades under the ticker ABT. The company is conducting clinical trials to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors.

What phase is veliparib in?

Veliparib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial evaluating veliparib in combination with temozolomide in solid tumor cancers has been completed.

What clinical trials is veliparib in?

Veliparib has one completed clinical trial, NCT01193140, titled "To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors." This Phase 2 study enrolled 24 participants in the United States and was not randomized or blinded.