Status:
COMPLETED
Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasm
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid t...
Eligibility Criteria
Inclusion
- Has histologically- or cytologically-confirmed metastatic or locally advanced solid tumor(s) that has (have) failed to respond to standard therapy, or for which adequate standard therapy does not exist
- Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression in the literature (e.g. prostate, pancreatic, colon, lung and breast)
- Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Demonstrates adequate organ function
Exclusion
- Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
- Is concurrently using growth hormone (GH), or growth hormone inhibitor
- Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has any primary CNS tumor - any symptomatic ascites or plural effusion
- Has a history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the participant's participation, or pose an additional risk to the participant
- Is pregnant or breast-feeding
Key Trial Info
Start Date :
August 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00694356
Start Date
August 4 2008
End Date
April 28 2009
Last Update
August 8 2018
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