A Phase 1/2 Study of SCH727965 in Patients With Malignant Melanoma
I. To determine the recommended phase 2 dose of SCH727965 administered as a 4-hour infusion
every other week in patients with advanced malignant melanoma. (Phase I) II. To determine
the 1-year overall survival of patients with malignant melanoma treated with SCH727965 at
the dose and schedule derived in the phase 1 part of the study. (Phase II)
I. To characterize the safety profile and toxicities of SCH727965 administered as a 4-hour
infusion every other week.
II. To determine the pharmacokinetics of SCH727965 administered as a 4-hour infusion every
III. To determine the proportion of patients with malignant melanoma who are alive without
progression of disease 6 months after beginning treatment with SCH727965 at the dose and
schedule derived in the phase 1 part of the study.
IV. To determine the objective response rate to SCH727965 of patients with malignant
melanoma enrolled to part 2 of the study.
V. To document cdk2, combined cdk2/1 and cdk9 inhibition in surrogate tissues and tumor.
VI. To correlate the degree of change of pharmacodynamic parameters in post-treatment
compared to pre-treatment samples with clinical outcome.
VII. To correlate the degree of change of parameters defining cdk2, cdk2/1 and cdk9
inhibition with pharmacokinetic parameters.
VIII. To correlate pre-treatment cdk2 levels with the degree of change of parameters
measuring cdk2 inhibition.
IX. To correlate pre-treatment cdk2 levels with clinical outcome. X. To correlate tumor p53
status with clinical outcome.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the
absence of disease progression and unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase-2 dose of SCH727965
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|