Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors and Hematologic Malignancy | Drug: INCB007839 | Phase 1 |
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 |
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 |
- Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments [ Time Frame: Baseline through study completion ]
- 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. ]
- Evaluation of PSA laboratory values for response [ Time Frame: Baseline and every visit through study termination ]
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | William V Williams, MD | Incyte Corporation |
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 |
Hematologic Neoplasms Neoplasms Neoplasms by Site Hematologic Diseases |