A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00804908

Purpose

The purpose of this study is to evaluate the efficacy of ABT-888 in combination with Temozolomide versus Temozolomide alone in subjects with metastatic melanoma.

Condition	Intervention	Phase
Skin Cancer Melanoma Metastatic Melanoma	Drug: temozolomide Drug: ABT-888 Drug: Placebo	Phase II

MedlinePlus related topics: Cancer Melanoma Skin Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma

Further study details as provided by Abbott:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Radiographic evaluation every 2 months, clinical evaluation monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: Every 12 weeks after final visit up to 18 months ] [ Designated as safety issue: No ]
12-month survival rate [ Time Frame: Every cycle (28 days) ] [ Designated as safety issue: No ]
6-month progression free survival rate [ Time Frame: Every cycle (28 days) ] [ Designated as safety issue: No ]
Time to disease progression [ Time Frame: Every cycle (28 days) ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2009
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator TMZ + ABT-888 at 20 mg BID	Drug: temozolomide 200 mg/m2 temozolomide daily for 5 days every 28 days Drug: ABT-888 Either 20 mg or 40 mg BID for 7 days every 28 days
2: Active Comparator TMZ + ABT-888 at 40 mg BID	Drug: temozolomide 200 mg/m2 temozolomide daily for 5 days every 28 days Drug: ABT-888 Either 20 mg or 40 mg BID for 7 days every 28 days
3: Placebo Comparator TMZ + Placebo	Drug: temozolomide 200 mg/m2 temozolomide daily for 5 days every 28 days Drug: Placebo Placebo BID for 7 days every 28 days

Eligibility

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

Criteria

Inclusion Criteria:

Histologically (or cytologically) confirmed metastatic melanoma.
Unresectable Stage III or Stage IV metastatic melanoma.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Subjects with no active brain metastases.
28 days since prior anti-cancer therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
Adequate hematologic, renal and hepatic function.
Partial Thromboplastin Time (PTT) is <= 1.5 x upper normal limit of institution's normal range and INR < 1.5.
Subject's with significant fluid retention may be allowed at the discretion of the PI.
Life expectancy > 12 weeks.
Females must not be pregnant.
Voluntarily signed informed consent.

Exclusion Criteria:

Lactate Dehydrogenase (LDH) > 2 x Upper Limit of Normal (ULN).
Ocular malignant melanoma.
History of CNS metastases or leptomeningeal disease.
Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).
Prior DNA damaging agents or cytotoxic chemotherapy.
Prior Whole Brain Radiation Therapy.
Received an investigational agent within 28 days of study.
History of seizure disorder and/or taking medication for seizure disorder.
Active malignancy within the past 5 years, except cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
Medical condition that would cause a high risk for toxicities.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804908

Contacts

Contact: Nancy Falotico	847-937-0370	nancy.falotico@abbott.com
Contact: Robin A Schuster	847-935-8782	robin.schuster@abbott.com

Locations

United States, Florida

Lakeland, Florida, United States, 33805
United States, Illinois

Park Ridge, Illinois, United States, 60068
United States, Texas

Houston, Texas, United States, 77024

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Vincent Giranda, MD

Abbott

More Information

Responsible Party:	Abbott ( Vincent Giranda, M.D, Ph.D. )
Study ID Numbers:	M10-440
Study First Received:	December 1, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00804908
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Skin Cancer
Melanoma
Metastatic Melanoma

MM
ABT-888
temozolomide

Study placed in the following topic categories:

Neuroectodermal Tumors
Skin Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Skin Neoplasms
Temozolomide
Neuroendocrine Tumors
Melanoma

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

ClinicalTrials.gov processed this record on January 16, 2009