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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01193140
First received: July 28, 2010
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.


Condition Intervention Phase
Solid Tumor Cancers
Drug: veliparib
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments


Secondary Outcome Measures:
  • 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 [ Time Frame: Every 12 weeks from Day1 and continuing up to 18 months following last dose. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: veliparib
Dose orally twice daily for 7 days, consecutively, every cycle
Other Name: ABT-888
Drug: Temozolomide
Dose orally once daily for 5 days, consecutively, every cycle
Other Name: Temodar

Detailed Description:

An extension study to evaluate the safety of veliparib in combination with temozolomide in subjects with solid tumors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193140

Locations
United States, California
Site Reference ID/Investigator# 43022
Encinitas, California, United States, 92024
Site Reference ID/Investigator# 42662
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Abbott
Investigators
Study Director: Bhardwaj Dessai, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01193140     History of Changes
Other Study ID Numbers: M12-273
Study First Received: July 28, 2010
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
veliparib
relapsed and refractory tumors
Temodar
temozolomide
ABT-888
Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014