A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients
1 other identifier
interventional
41
0 countries
N/A
Brief Summary
This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedNovember 21, 2017
January 1, 2012
2.8 years
September 5, 2007
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Tolerated Dose
Duration of Study
Safety and Tolerability
Duration of Study
Pharmacokinetic Profile
Duration of Study
Study Arms (1)
Open Label
EXPERIMENTALWithin each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ.
Interventions
Eligibility Criteria
You may qualify if:
- Dose escalation and expanded safety cohorts
- Evaluable disease, histologically confirmed malignancy (metastatic or unresectable) and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective
- ECOG Performance Score less than or equal to 2
- Adequate hematologic, renal and hepatic function
- Normal sodium, calcium and magnesium levels
- Voluntarily signed informed consent
- Expanded Safety Cohorts Only
- Population:
- Metastatic melanoma (MM)
- Hepatocellular carcinoma (HCC) Child Pugh Category A and B classification only
- BRCA deficient tumor status\*: advanced breast cancer (with soft tissue disease), or advanced ovarian cancer, or advanced primary peritoneal cancer, or advanced fallopian tube cancer\*
- \*Patients must have histologically or cytologically confirmed solid tumors with a positive genetic test result documenting BRCA 1 or BRCA 2 mutation status, to be considered eligible.
- Serial tumor biopsies: Required for all subjects enrolled in one of the Expanded Low Dose Safety Cohorts.
You may not qualify if:
- Dose Escalation and Expanded Safety Cohorts
- Known central nervous system (CNS) metastases or CNS primary cancer.
- Previous or current malignancies at other sites, except: adequately treated in situ carcinoma of cervix uteri; basal/squamous cell carcinoma of skin; previous malignancy considered cured.
- Previous history or current seizure disorder.
- Clinically significant and uncontrolled major medical condition(s) or any medical condition that places the subject at an unacceptably high risk for toxicities.
- Transplant recipients and patients receiving combination anti-retroviral therapy for HIV due to the use of immunosuppressant therapies.
- Lactating or pregnant female.
- Chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy will not be allowed within either 4 weeks, or 5 half lives of a targeted therapy prior to study drug administration (Study Day 1).
- Prior therapy with regimens containing dacarbazine (DTIC) or TMZ is not permitted.
- Anti-cancer therapy is not permitted during the treatment portion of the study.
- Hormone therapy, bisphosphonates or LHRH-agonists for prostate cancer are permitted prior to and during the study.
- Significant adverse event or toxicity due to previous anti-cancer treatment that has not recovered to within one grade level (not to exceed Grade 2) of baseline.
- Expanded Safety Cohorts Only:
- MM Only: Prior treatment with DNA damaging agents or cytotoxic chemotherapy including carboplatin, cisplatin, fotemustine, paclitaxel, vincristine, TMZ and DTIC.
- Prior therapy with biologic agents (including IL-2, interferon, bevacizumab, vaccines and immunostimulants) and signal transduction inhibitors (including sorafenib, erlotinib, sutent and elesclomol) are allowed.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (1)
Nuthalapati S, Munasinghe W, Giranda V, Xiong H. Clinical Pharmacokinetics and Mass Balance of Veliparib in Combination with Temozolomide in Subjects with Nonhematologic Malignancies. Clin Pharmacokinet. 2018 Jan;57(1):51-58. doi: 10.1007/s40262-017-0547-z.
PMID: 28497258RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bhardwaj Desai, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 10, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2010
Last Updated
November 21, 2017
Record last verified: 2012-01