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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00820560
First received: January 8, 2009
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Solid Tumors
Drug: INCB007839
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments [ Time Frame: Baseline through study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Evaluation of PSA laboratory values for response [ Time Frame: Baseline and every visit through study termination ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820560

Locations
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
Study Director: William V Williams, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00820560     History of Changes
Other Study ID Numbers: INCB 7839-201
Study First Received: January 8, 2009
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014