Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871663
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Lymphoma, Non-Hodgkin Multiple Myeloma Leukemia, Lymphocytic, Chronic. B-Cell Drug: SCH 727965 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity. [ Time Frame: End of trial ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications of Results:
Other Publications:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00871663     History of Changes
Other Study ID Numbers: P04629
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Multiple Myeloma
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, B-Cell