A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.