NCT00937937

Dinaciclib in Treating Patients With Stage IV Melanoma

A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acral Lentiginous Melanoma
• Cutaneous Nodular Melanoma
• Lentigo Maligna Melanoma
• Low-CSD Melanoma
• Mucosal Melanoma
• Recurrent Melanoma
• Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions

Type	Name	Description
DRUG	Dinaciclib	Given IV

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-10-22
• Completion: 2026-03-19
• First posted: 2009-07-13
• Last updated: 2026-03-20
• Results posted: 2016-07-22

Locations

190 sites across 1 country: United States