NCT01193140CompletedPhase 2
An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Experimental
Intervention: veliparib (Drug)
Arm A
Experimental
Intervention: Temozolomide (Drug)
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.)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid TumorsOvarian CancerSolid TumorsGastric CancerColon CancerLung CancerBreast CancerNCT02033551AbbVie47
Completed
Phase 3
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung CancerSquamous Non-Small Cell Lung CancerNCT02106546AbbVie970
Completed
Not Applicable
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast CancerMetastatic Triple Negative Breast CancerNCT02158507University of Alabama at Birmingham20
Active, not recruiting
Phase 2
Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 MutationsAnaplastic AstrocytomaMalignant GliomaGlioblastomaNCT03581292National Cancer Institute (NCI)38
Terminated
Phase 2
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid TumorsLocally Advanced or Metastatic Solid TumorsGenes, BRCA 1NCT03565991Pfizer202