A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Veliparib

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.

• Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.

• The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.