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

Sponsor
Incyte Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02257619
Collaborator
(none)
9
Enrollment
16
Locations
1
Arm
19
Actual Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Dose Limiting Toxicities (DLTs) [Baseline through 21 days; the end of cycle 1.]

      Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.

    4. 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.

    5. Peripheral neuropathy ≥ Grade 3.

    6. 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.

    7. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.

    8. Unwilling to be transfused with blood components.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hot Springs Arizona United States
    2 Los Angeles California United States
    3 Washington District of Columbia United States
    4 Orlando Florida United States
    5 Detroit Michigan United States
    6 Pascagoula Mississippi United States
    7 Kansas City Missouri United States
    8 Omaha Nebraska United States
    9 Lebanon New Hampshire United States
    10 Goldsboro North Carolina United States
    11 Cleveland Ohio United States
    12 Gettysburg Pennsylvania United States
    13 Hershey Pennsylvania United States
    14 Pawtucket Rhode Island United States
    15 Spartanburg South Carolina United States
    16 Round Rock Texas United States

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Amit Pande, M.D., Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02257619
    Other Study ID Numbers:
    • INCB 39110-203
    First Posted:
    Oct 6, 2014
    Last Update Posted:
    Jan 25, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Incyte Corporation
    Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Jan 25, 2018