Trial | NCT00820560  Report issue

Title

Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB007839 Following Multiple Oral Doses in Patients With Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    incb7839 ...

  • Study Participants

    41
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 prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
Study Started
Jan 31
2005
Primary Completion
Jan 31
2009
Study Completion
Jan 31
2009
Last Update
Jan 17
2018

Drug INCB007839

INCB007839 100 or 200 mg/dose as IR capsules

INCB07839 100mg, immediate release (IR) capsules Experimental

INCB07839 200 mg IR capsules Experimental

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted