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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00612664 |
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Date of registration:
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30/01/2008 |
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Primary sponsor: |
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Public title:
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Phase II, 2nd Line Melanoma - RAND Monotherapy
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Scientific title:
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A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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158 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00612664 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Brazil
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Canada
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Denmark
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France
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Germany
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Italy
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must have been previously treated with one line of systemic anti-cancer
therapy (non-experimental or experimental) for metastatic disease, and relapsed,
failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has
been administered as an adjuvant and/or neoadjuvant therapy, the subject must have
documented disease progression from the last treatment and also received one
additional line of systemic therapy for metastatic disease.
- Men and women, who are at least 18 years of age
Exclusion Criteria:
- Ocular or mucosal melanoma
- Complete surgical resection of all identifiable sites of disease
- Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain
metastasis are not eligible unless brain metastases are ruled out by computerized
axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable
brain metastasis and those who were previously treated with radiotherapy or surgery
must have no current evidence of symptomatic brain metastasis and are off steroid
therapy for at least 4 weeks prior to randomization
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma
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Intervention(s)
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Drug: Anti-CD137 (4-1BB) (BMS-663513)
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Primary Outcome(s)
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Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
[Time Frame: every 6 weeks starting at week 12 after randomization]
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Secondary Outcome(s)
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1-year survival
[Time Frame: end of study]
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Biomarkers
[Time Frame: throughout the study]
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Disease control rate
[Time Frame: end of study]
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Disease response rate
[Time Frame: end of study]
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Pharmacodynamics
[Time Frame: throughout the study]
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Pharmacokinetics
[Time Frame: throughout the study]
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Safety profiles
[Time Frame: throughout the study]
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Secondary ID(s)
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CA186-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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