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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate

Outcome Time Frame:

every 6 weeks starting at week 12 after randomization

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA186-006

NCT ID:

NCT00612664

Start Date:

March 2008

Completion Date:

October 2009

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Providence Portland Medical CenterPortland, Oregon  97213-3635
The Angeles Clinic & Research InstituteLos Angeles, California  90404
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Yale University School Of MedicineNew Haven, Connecticut  06520
University of TexasHouston, Texas  77225
Harry & Jeanette Weinberg Cancer Inst At Franklin SquareBaltimore, Maryland  21237
Dana-Farber Cancer InstBoston, Massachusetts  02115
Mem Sloan-Ket Can CtrNew York, New York  10021
Blumenthal Cancer Center, Carolinas Medical CenterCharlotte, North Carolina  28204