A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasm
Both
Neoplasm
Trial Information
A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors
Inclusion Criteria:
- Patients must be at least 18 years of age, with adequate organ function, and an ecog
performance of <2
Exclusion Criteria:
- No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study
participation
- Patients must not have primary central nervous system tumor
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.
Outcome Time Frame:
18 Months
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
2007_016
NCT ID:
NCT00496353
Start Date:
July 2007
Completion Date:
November 2008
Related Keywords:
- Neoplasm
- Neoplasm Malignant
- Neoplasms
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