Status:

COMPLETED

Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors

Lead Sponsor:

Incyte Corporation

Conditions:

Solid Tumors and Hematologic Malignancy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with ...

Eligibility Criteria

Inclusion

  • Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

  • Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
  • Evidence of venous thrombosis by flow Doppler examination at Screening
  • A history of thrombosis or a coagulation disorder
  • Patients with a contraindication to use of low dose warfarin and/or aspirin.
  • Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
  • Brain metastases or spinal cord compression
  • Impaired renal function
  • Inadequate bone marrow reserve

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00820560

Start Date

January 1 2005

End Date

January 1 2009

Last Update

January 17 2018

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Aurora, Colorado, United States

2

Baltimore, Maryland, United States

3

Philadelphia, Pennsylvania, United States

4

Nashville, Tennessee, United States

Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors | DecenTrialz