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A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib. SECONDARY OBJECTIVES: I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease. III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma. OUTLINE: This is a multicenter study. Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Providence Hospital
Mobile, Alabama, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Start Date
July 1, 2009
Primary Completion Date
October 22, 2013
Completion Date
March 19, 2026
Last Updated
March 20, 2026
72
ACTUAL participants
Dinaciclib
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT03698019
NCT04462406
Data Source & Attribution
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