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

Solid Tumors and Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820560
• Other study ID #: INCB 7839-201
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2009
• Last updated: January 15, 2018
• Start date: January 2005
• Est. completion date: January 2009

Study information

• Verified date: January 2018
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors and Hematologic Malignancy

Intervention

Drug:
• INCB007839
INCB007839 100 or 200 mg/dose as IR capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments		Baseline through study completion
Secondary	Evaluation of response rates as measured by RECIST criteria		At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Secondary	Evaluation of PSA laboratory values for response		Baseline and every visit through study termination
Secondary	Evaluation of PD markers for HER2 and ErbB ligand levels		Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.