Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

January 18, 2018 updated by: Incyte Corporation

A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer

The primary objectives of this study is to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not conducted.

In Part 2, the randomized portion, the objective is to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone.

The secondary objectives of this study (Part 2) are to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

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
    • Arizona
      • Hot Springs, Arizona, United States
    • California
      • Los Angeles, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Orlando, Florida, United States
    • Michigan
      • Detroit, Michigan, United States
    • Mississippi
      • Pascagoula, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • North Carolina
      • Goldsboro, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Texas
      • Round Rock, Texas, 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:

  1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
  2. Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  4. Life expectancy of ≥12 weeks.

Exclusion Criteria:

  1. Received prior treatment with docetaxel.

  2. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:

    1. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
    2. Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
  3. Peripheral neuropathy ≥ Grade 3.
  4. Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
  5. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
  6. Unwilling to be transfused with blood components.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Itacitinib plus docetaxel
Drug: Itacitinib
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
Other Names:
  • INCB039110
Drug: docetaxel
Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: Baseline through 21 days; the end of cycle 1.
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
Baseline through 21 days; the end 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: Amit Pande, M.D., 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 (Actual)

September 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 39110-203

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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