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

January 15, 2018 updated by: Incyte Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Time Frame: Baseline through study completion
Baseline through study completion

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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
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.
Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: William V Williams, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 7839-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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