Status:
TERMINATED
A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This purpose of the study is to determine what dose of JNJ-38877605 is safe and if JNJ-38877605 has any effect in patients with advanced or refractory solid tumors for which there are not alternative ...
Detailed Description
JNJ-38877605 is a new drug being developed for the treatment of cancer. It is an inhibitor of mesenchymal epithelial transition (Met) kinase, a substance identified in many cancers. This is the first ...
Eligibility Criteria
Inclusion
- Confirmed advanced or refractory solid tumor no longer eligible for approved therapies
- Eastern Cooperative Oncology Group performance status test score of \<=2
- Must meet protocol lab criteria which will include lab assessment of adequate bone marrow function, liver function, and renal function.
Exclusion
- Any medical condition that requires wound healing during the study (for example chronic leg ulcers, gastric ulcer disease, or expected major surgery)
- Major surgery within 3 weeks before enrollment
- Decreased or deficient coagulability of blood (for example genetic defects such as protein Z deficiency) or compliance problems in subjects required to take anticoagulants (e.g., coumarin derivates, acetylsalicylic acid) which could result in decreased or deficient coagulability
- Chemotherapy (for nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other investigational agent within 3 weeks before study drug administration
- antibody therapy within 3 months before administration of JNJ-38877605
- brain metastases
- History of uncontrolled heart disease within 12 months before enrollment or any protocol-defined cardiovascular abnormalities
- Patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00651365
Start Date
February 1 2008
End Date
December 1 2010
Last Update
March 8 2013
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