Know Cancer

or
forgot password

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 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments

Outcome Time Frame:

Baseline through study completion

Safety Issue:

No

Principal Investigator

William V Williams, MD

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation

Authority:

United States: Food and Drug Administration

Study ID:

INCB 7839-201

NCT ID:

NCT00820560

Start Date:

January 2005

Completion Date:

January 2009

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Denver, Colorado  
Baltimore, Maryland  21287