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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Leukemia, Lymphocytic, Chronic. B-Cell; Multiple Myeloma; Solid Tumors; Lymphoma, Non-Hodgkin

Treatments: Drug: SCH 727965

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871663

P04629

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 3 patient groups

Advanced solid tumors

Experimental group

Description:

Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts

Treatment:

Drug: SCH 727965

Non-Hodgkin's lymphoma and multiple myeloma

Experimental group

Description:

Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965

Treatment:

Drug: SCH 727965

B cell chronic lymphocytic leukemia

Experimental group

Description:

Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts

Treatment:

Drug: SCH 727965