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

This is an interventional treatment trial for Solid Tumors Read More

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.