Status:
COMPLETED
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms
Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed s...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
- Participant must have Performance Status 0 or 1.
- Participant must have adequate organ function.
- Exclusion Criteria
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
- Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
- Participant has known hypersensitivity to the components of study drug or its analogs.
- Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00880568
Start Date
April 1 2009
End Date
January 1 2011
Last Update
February 19 2015
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