A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects With Advanced Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
Both
Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma
Trial Information
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects With Advanced Malignancies
Inclusion Criteria:
- Age >=18 years, either sex, any race.
- Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or
multiple myeloma.
- There must be no known standard therapy, or disease must be refractory to standard
therapy.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
Exclusion Criteria:
- Symptomatic brain metastases or primary central nervous system malignancy.
- Previous radiation therapy to >25% of the total bone marrow.
- Previous treatment with SCH 727965.
- Known HIV infection.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity
Outcome Time Frame:
End of trial
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
P04630
NCT ID:
NCT00871910
Start Date:
October 2006
Completion Date:
February 2010
Related Keywords:
- Solid Tumors
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
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