Status:
COMPLETED
Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumors
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00871663
Start Date
August 1 2006
End Date
October 1 2012
Last Update
April 20 2015
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