Status:
COMPLETED
A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these pat...
Detailed Description
JNJ-26854165 is a new drug in development and belongs to a class of drugs that act on the specific protein present in cells. It may stop cancer cells from growing or kill cancer cells. In this study, ...
Eligibility Criteria
Inclusion
- Confirmed solid malignancy, in advanced, incurable stage or not responsive to available therapies
- performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2
- life expectancy \> 3 months
- must consent to skin biopsies
- must meet protocol-defined criteria for lab assessments and heart function.
Exclusion
- Known central nervous system metastasis
- chemotherapy, radiotherapy, immunotherapy or use of any investigational agent within 2 weeks before dosing
- treatment within last 6 months or expected to require treatment with amiodarone derivates during study participation
- currently treated and/or expected to require treatment with warfarin/coumarine derivates during study participation
- history of uncontrolled heart disease or uncontrolled arterial hypertension
- eye abnormality at screening examination
- \>70% stenosis of lumen on Carotid duplex assessment at screening.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00676910
Start Date
November 1 2006
End Date
February 1 2010
Last Update
March 26 2010
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