Overview
A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Abbott
AbbVieTreatments:
Dacarbazine
Temozolomide
Veliparib
Criteria
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.