A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00526617

Purpose

A Phase 1, multicenter, dose-escalation study evaluating the safety and tolerability of the PARP inhibitor ABT-888 in combination with Temozolomide in subjects with metastatic melanoma and non-hematologic malignancies, including BRCA deficient breast and ovarian cancer.

Condition	Intervention	Phase
Non-Hematologic Malignancies (Solid Tumor) Metastatic Melanoma (MM) BRCA Deficient Breast Cancer BRCA Deficient Ovarian Cancer	Drug: ABT-888 Drug: Temozolomide	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Melanoma Ovarian Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM)

Further study details as provided by Abbott:

Primary Outcome Measures:

Maximum Tolerated Dose [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
Safety and Tolerability [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
Pharmacokinetic Profile [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	August 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ.	Drug: ABT-888 Oral capsules Drug: Temozolomide Oral capsules

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: Advanced BRCA deficient breast cancer (with soft tissue disease), advanced BRCA deficient ovarian cancer, and metastatic melanoma.
- Tumor biopsies: Required for subjects with Metastatic Melanoma enrolled in the Expanded Low Dose Safety Cohort.

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.
- Prior therapy with dacarbazine (DTIC) or temozolomide (TMZ).
- Anti-cancer including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within either 4 weeks, or 5 half lives of a targeted therapy, prior to Study Day 1.
- 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.
- 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.
- Subject is receiving combination anti-retroviral therapy for HIV.
- Lactating or pregnant female
Expanded Safety Cohorts Only
- Prior cytotoxic chemotherapy limitations: Metastatic melanoma - may not have received more than one (1) treatment.
- Anti-coagulant restrictions for subjects that have tumor biopsies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526617

Contacts

Contact: Debra L Rehwinkel	(847) 937-5254	debra.rehwinkel@abbott.com
Contact: Betsy B Gamlin	(847) 938-3630	betsy.gamlin@abbott.com

Locations

United States, Arizona
Mayo Clinic Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mayo Clinic Clinical Trials Referral Office 507-538-7623
United States, Minnesota
Mayo Clinic Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Referral Office 507-538-7623

Sponsors and Collaborators

Abbott

More Information

Responsible Party:	Abbott ( Joyce Steinberg, MD, Global Medical Director )
Study ID Numbers:	M06-862
Study First Received:	September 5, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00526617
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Solid Tumor
Melanoma
BRCA deficient breast and ovarian cancer

Temozolomide (TMZ)
ABT-888
Mayo Clinic

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Temozolomide
Melanoma

Neuroendocrine Tumors
Genital Diseases, Female
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Endocrinopathy
Nevus
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009