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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors and Hematologic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INCB07839 100mg, immediate release (IR) capsules

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

INCB007839 100 or 200 mg/dose as IR capsules

INCB07839 200 mg IR capsules

Group Type EXPERIMENTAL

INCB007839

Intervention Type DRUG

INCB007839 100 or 200 mg/dose as IR capsules

Interventions

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INCB007839

INCB007839 100 or 200 mg/dose as IR capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No