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veliparib

Phase 3

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

veliparib development status

Highest phase Phase 3 run by AbbVie (NCT02163694)
Phase scored for ABTPhase 2
Registered trials 33 across 10 sponsors since Sep 2007

veliparib target and mechanism

Molecular targetPARP1, PARP3, PARP2
Target classInhibitor
ModalitySmall molecule

Also known as ABT-888

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

veliparib clinical trials

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?

Veliparib is an investigational small molecule drug being developed by Abbott Laboratories for solid tumor cancers. It is designed as an inhibitor of the PARP1, PARP2, and PARP3 enzymes. Veliparib has reached Phase 2 clinical development and is not approved for commercial use.

What is veliparib used for?

Veliparib is being studied for the treatment of solid tumor cancers. Its clinical testing has focused on use in combination with temozolomide, a chemotherapy agent, in adult patients with solid tumors. It remains an investigational therapy and is not approved for any indication.

What does veliparib target?

Veliparib targets the poly(ADP-ribose) polymerase enzymes PARP1, PARP2, and PARP3. It acts as an inhibitor of these targets. PARP enzymes are involved in DNA repair processes, and inhibiting them is the basis for studying veliparib in solid tumor cancers.

Who makes veliparib?

Veliparib is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor behind the clinical development program for this PARP inhibitor in solid tumor cancers.

What phase is veliparib in?

Veliparib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. Its development has focused on solid tumor cancers in combination with temozolomide.

What clinical trials is veliparib in?

Veliparib has been evaluated in the completed Phase 2 trial NCT01193140, titled a study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors. That trial enrolled 24 participants in the United States and has completed.