Back to resultsOpen-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
Primary Purpose
Solid Tumors and Hematologic Malignancy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INCB007839
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors and Hematologic Malignancy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
INCB07839 100mg, immediate release (IR) capsules
INCB07839 200 mg IR capsules
Arm Description
Outcomes
Primary Outcome Measures
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Secondary Outcome Measures
Evaluation of response rates as measured by RECIST criteria
Evaluation of PSA laboratory values for response
Evaluation of PD markers for HER2 and ErbB ligand levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00820560
Brief Title
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors and Hematologic Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB07839 100mg, immediate release (IR) capsules
Arm Type
Experimental
Arm Title
INCB07839 200 mg IR capsules
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
INCB007839
Intervention Description
INCB007839 100 or 200 mg/dose as IR capsules
Primary Outcome Measure Information:
Title
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Time Frame
Baseline through study completion
Secondary Outcome Measure Information:
Title
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.
Title
Evaluation of PSA laboratory values for response
Time Frame
Baseline and every visit through study termination
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William V Williams, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Aurora
State/Province
Colorado
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
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