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

Sponsor:	Abbott
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Skin Cancer

Drug Information available for: Temozolomide ABT 888

U.S. FDA Resources

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 4 weeks or as needed after subject is registered as off-study, 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:	346
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 TMZ + ABT-888 at 20 mg BID	Drug: temozolomide 150 mg/m2 temozolomide daily for 5 days every 28 days Other Name: Temodar, Temodal Drug: ABT-888 Either 20 mg or 40 mg BID for 7 days every 28 days Other Name: ABT-888
Active Comparator: 2 TMZ + ABT-888 at 40 mg BID	Drug: temozolomide 150 mg/m2 temozolomide daily for 5 days every 28 days Other Name: Temodar, Temodal Drug: ABT-888 Either 20 mg or 40 mg BID for 7 days every 28 days Other Name: ABT-888
Placebo Comparator: 3 TMZ + Placebo	Drug: temozolomide 150 mg/m2 temozolomide daily for 5 days every 28 days Other Name: Temodar, Temodal Drug: Placebo Placebo BID for 7 days every 28 days Other Name: Placebo

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 history of brain metastases demonstrated by a baseline MRI,or subjects with a history of previously treated brain metastases who have history of operable/SRS treatable brain metastases and completed surgical resection/stereotactic radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to Day 1.
have baseline MRI that shows no evidence of active intercranial disease
have discontinued taking medications for symptom management of brain metastases at least 7 days prior to Day 1
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

Show 57 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Yan Luo, M.D, Ph.D., MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00804908 History of Changes
Other Study ID Numbers:	M10-440, 2008-004941-27
Study First Received:	December 1, 2008
Last Updated:	December 29, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Abbott:

Skin Cancer, Melanoma, Metastatic Melanoma, MM, ABT-888, temozolomide

Additional relevant MeSH terms:

Skin Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

Nevi and Melanomas
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012