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

Incyte

Status and phase

Completed

Phase 1

Conditions

Solid Tumors and Hematologic Malignancy

Treatments

Drug: INCB007839

Study type

Interventional

Funder types

Industry

Identifiers

NCT00820560

INCB 7839-201

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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