To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors

NCT ID: NCT01193140

Last Updated: 2012-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-11-30

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

Conditions

Solid Tumor Cancers

Keywords

veliparib; relapsed and refractory tumors; Temodar; temozolomide; ABT-888; Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

veliparib

Intervention Type: DRUG

Dose orally twice daily for 7 days, consecutively, every cycle

Temozolomide

Intervention Type: DRUG

Dose orally once daily for 5 days, consecutively, every cycle

Interventions

veliparib

Dose orally twice daily for 7 days, consecutively, every cycle

Intervention Type: DRUG

Temozolomide

Dose orally once daily for 5 days, consecutively, every cycle

Intervention Type: DRUG

Other Intervention Names

ABT-888; Temodar

Eligibility Criteria

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 neutrophil count (ANC ≥ 1,500/mm3 (1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L); • Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal; • Hepatic function: AST and ALT ≤ 2.5 × the ULN range. For subjects with liver metastases, AST and ALT < 5 × the ULN range; Bilirubin ≤ 1.5 × the ULN range. • Partial Thromboplastin Time (PTT) must be ≤ 1.5 × the ULN range and INR < 1.5. Subjects on anticoagulant therapy (such as Coumadin) will have an appropriate PTT and INR as determined by the Investigator.

4. Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to initiation of treatment and a negative urine pregnancy test on Cycle 1 Day 1 and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. • Total abstinence from sexual intercourse (minimum one complete menstrual cycle); • Vasectomized partner; • Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; • Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); • IUD (Intrauterine Device).

Exclusion Criteria

1. Subject has received anticancer agent(s) or an investigational agent (except for veliparib) within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.

2. Subject has undergone major surgery within the previous 28 days prior to study drug administration.

3. Subject has received radiotherapy within 28 days prior to study drug administration.

4. Clinically significant and uncontrolled major medical condition(s) including but not limited to: • 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.

5. Subject is pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhardwaj Dessai, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 43022

Encinitas, California, United States

Site Reference ID/Investigator# 42662

Santa Monica, California, United States

Countries

United States

Other Identifiers

M12-273

Identifier Type: -

Identifier Source: org_study_id