A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
| Registry | NCT00871663 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 123 (Actual) |
| Sponsor | Merck Sharp & Dohme LLC (Industry) |
| Conditions | Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic. B-Cell |
| Interventions | SCH 727965 (Drug) |
| Dates | start 2006-08-01, primary completion 2012-10-01, completion 2012-10-01, first posted 2009-03-30, last updated 2015-04-20 |
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All trials for Solid Tumors All trials for Lymphoma, Non-Hodgkin All trials of SCH 727965
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Advanced solid tumors | Experimental | Drug: SCH 727965 | Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts |
| Non-Hodgkin's lymphoma and multiple myeloma | Experimental | Drug: SCH 727965 | Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965 |
| B cell chronic lymphocytic leukemia | Experimental | Drug: SCH 727965 | Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts |
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Age >=18 years, either sex, any race.
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
* There must be no known standard therapy, or disease must be refractory to standard therapy
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters
* For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
* Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
* Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.
* Subjects with multiple myeloma must have measurable disease defined as:
* Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
* Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
* serum free light chain ratio greater than 5 times the normal ratio limit; and/or
* measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
* bone marrow involvement greater than 30%.
* For B-cell chronic lymphocytic leukemia (B-CLL):
* Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
* Disease must be evaluable according to NCI-WG response criteria.
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.