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

NCT00820560 | Completed Phase 1

• 1 other identifier: INCB 7839-201
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

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.

Conditions

Solid Tumors and Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

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

  Baseline through study completion

Secondary Outcomes (3)

• Evaluation of response rates as measured by RECIST criteria

  At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.

• Evaluation of PSA laboratory values for response

  Baseline and every visit through study termination

• Evaluation of PD markers for HER2 and ErbB ligand levels

  Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.

Study Arms (2)

INCB07839 100mg, immediate release (IR) capsules

EXPERIMENTAL

Drug: INCB007839

INCB07839 200 mg IR capsules

EXPERIMENTAL

Drug: INCB007839

Interventions

INCB007839 DRUG

INCB007839 100 or 200 mg/dose as IR capsules

INCB07839 100mg, immediate release (IR) capsules; INCB07839 200 mg IR capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• William V Williams, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (4)