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OpenTrials
Completed

NCT Number: NCT00820560

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

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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Key information

Conditions

Solid Tumors and Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INCB007839

Drug

INCB007839 100 or 200 mg/dose as IR capsules

Primary outcomes

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

    Time frame: Baseline through study completion

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2009
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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