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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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.