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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00804908
First received: December 1, 2008
Last updated: October 20, 2014
Last verified: October 2014
  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
Melanoma
Metastatic Melanoma
Skin Cancer
Drug: temozolomide
Drug: ABT-888
Drug: Placebo
Phase 2

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:


Further study details as provided by AbbVie:

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: December 2014
Estimated Primary Completion Date: December 2014 (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
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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 57 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mark D McKee, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, 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: October 20, 2014
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 AbbVie:
ABT-888
Skin cancer
MM
Temozolomide
Melanoma
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Skin Diseases
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014