An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Veliparib
- Conditions
- Breast Cancer
- Sponsor
- AbbVie
- Enrollment
- 47
- Locations
- 5
- Primary Endpoint
- Number of subjects with adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- •For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
- •If the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
- •Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
Exclusion Criteria
- •Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
- •Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
- •Uncontrolled nausea/vomiting/diarrhea;
- •Active uncontrolled infection;
- •Symptomatic congestive heart failure;
- •Unstable angina pectoris or cardiac arrhythmia;
- •Psychiatric illness/social situation that would limit compliance with study requirements;
- •Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
- •Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.
- •Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
Arms & Interventions
Arm A - Veliparib Monotherapy
Subjects in this arm will be dosed with Veliparib continuous dosing.
Intervention: Veliparib
Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Intervention: Veliparib
Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Intervention: Carboplatin
Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Intervention: Paclitaxel
Arm C Veliparib in Combination with Modified FOLFIRI
Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.
Intervention: Veliparib
Arm C Veliparib in Combination with Modified FOLFIRI
Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.
Intervention: FOLFIRI
Outcomes
Primary Outcomes
Number of subjects with adverse events
Time Frame: Measured up to 30 days after the last dose of study drug.
Secondary Outcomes
- Objective Response Rate (ORR)(Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.)
- Overall Survival (OS)(Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.)
- Time to Disease Progression (TTP)(Assessed at each visit up to 18 months after the last subject has enrolled in the study.)
- Progression Free Survival (PFS)(Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.)
- Clinical Laboratory Tests(Up to 18 months.)
- Electrocardiogram(Up to 18 months.)
- Tumor Assessment(Up to 18 months.)