|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00676910 |
|
Date of registration:
|
08/05/2008 |
|
Primary sponsor: |
|
|
Public title:
|
A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.
|
|
Scientific title:
|
A Phase I Study to Determine the Safety, Pharmacology, and Pharmacodynamics of JNJ26854165 in Subjects With Advanced Stage and/or Refractory Solid Tumors |
|
Date of first enrolment:
|
November 2006 |
|
Target sample size:
|
71 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00676910 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Belgium
|
Spain
| | | | | | |
|
Contacts
|
|
Name:
|
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Neoplasms
|
|
Intervention(s)
|
|
Drug: JNJ-26854165
|
|
Primary Outcome(s)
|
|
Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
|
|
Secondary Outcome(s)
|
|
Determine how JNJ-26854165 is absorbed, broken down and eliminated and the effect of food on these processes. Explore how JNJ-26854165 effects the body and the disease.Determine how JNJ-26854165 interacts with other specific drugs.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|