Dinaciclib in Treating Patients With Stage IV Melanoma
A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Listed as NCT00937937, this observational or N/A phase trial focuses on Acral Lentiginous Melanoma and Cutaneous Nodular Melanoma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 54 times since 2009, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
54 versions recorded-
May 4, 2026 — Present [daily]
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First recorded
Jul 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .