- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526617
A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients
A Phase I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Lower Dose Expanded Safety Cohorts Only
- Anti-coagulant restrictions for subjects that have tumor biopsies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open Label
Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ.
|
Oral capsules
Oral capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose
Time Frame: Duration of Study
|
Duration of Study
|
Safety and Tolerability
Time Frame: Duration of Study
|
Duration of Study
|
Pharmacokinetic Profile
Time Frame: Duration of Study
|
Duration of Study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Liver Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Liver Neoplasms
- Fallopian Tube Diseases
- Neuroendocrine Tumors
- Nevi and Melanomas
- Neoplasms
- Carcinoma, Hepatocellular
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Temozolomide
- Veliparib
Other Study ID Numbers
- M06-862
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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