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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820560
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors and Hematologic Malignancy Drug: INCB007839 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: INCB07839 100mg, immediate release (IR) capsules Drug: INCB007839
INCB007839 100 or 200 mg/dose as IR capsules
Experimental: INCB07839 200 mg IR capsules Drug: INCB007839
INCB007839 100 or 200 mg/dose as IR capsules


Outcome Measures
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Primary Outcome Measures :
  1. Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments [ Time Frame: Baseline through study completion ]

Secondary Outcome Measures :
  1. Evaluation of response rates as measured by RECIST criteria [ Time Frame: At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle. ]
  2. Evaluation of PSA laboratory values for response [ Time Frame: Baseline and every visit through study termination ]
  3. Evaluation of PD markers for HER2 and ErbB ligand levels [ Time Frame: Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820560


Locations
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United States, Colorado
Aurora, Colorado, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: William V Williams, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00820560    
Other Study ID Numbers: INCB 7839-201
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases