Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00871663
First received: March 26, 2009
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors Lymphoma, Non-Hodgkin Multiple Myeloma Leukemia, Lymphocytic, Chronic. B-Cell |
Drug: SCH 727965 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity. [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]
- In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes. [ Time Frame: End of trial ] [ Designated as safety issue: No ]
| Enrollment: | 123 |
| Study Start Date: | August 2006 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Advanced solid tumors
Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts
|
Drug: SCH 727965
Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
|
|
Experimental: Non-Hodgkin's lymphoma and multiple myeloma
Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965
|
Drug: SCH 727965
Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
|
|
Experimental: B cell chronic lymphocytic leukemia
Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts
|
Drug: SCH 727965
Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00871663 History of Changes |
| Other Study ID Numbers: | P04629 |
| Study First Received: | March 26, 2009 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 21, 2013