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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Gastric Cancer; Colon Cancer; Lung Cancer; Solid Tumors; Ovarian Cancer

Treatments: Drug: Paclitaxel; Drug: FOLFIRI; Drug: Veliparib; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02033551

M14-144

2013-003137-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Arm A - Veliparib Monotherapy

Experimental group

Description:

Subjects in this arm will be dosed with Veliparib continuous dosing.

Treatment:

Drug: Veliparib

Arm B - Veliparib in Combination with Carboplatin & Paclitaxel

Experimental group

Description:

Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.

Treatment:

Drug: Veliparib

Drug: Carboplatin

Drug: Paclitaxel

Arm C Veliparib in Combination with Modified FOLFIRI

Experimental group

Description:

Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.

Treatment:

Drug: Veliparib

Drug: FOLFIRI