NCT00676910

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 patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 26, 2010

Status Verified

March 1, 2010

First QC Date

May 8, 2008

Last Update Submit

March 24, 2010

Conditions

Neoplasms

Keywords

Advanced CancerMalignanciesNeoplasmsIncurable Solid Cancers

Outcome Measures

Primary Outcomes (1)

  • Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.

Secondary Outcomes (1)

  • 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.

Interventions

JNJ-26854165DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

JNJ 26854165

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

November 1, 2006

Study Completion

February 1, 2010

Last Updated

March 26, 2010

Record last verified: 2010-03