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Trial record 5 of 18 for:    INCB039110

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

This study has been terminated.
(Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.)
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02257619
First received: September 26, 2014
Last updated: July 3, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to determine if INCB039110, in combination with docetaxel, is safe and effective in the treatment of non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: INCB039110 Drug: Placebo Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Part 1: Determination of the safe and tolerable dose of INCB039110 in combination with docetaxel as measured by the number of dose-limiting toxicities (DLTs) observed. Safety and tolerability of the regimen will be assessed the end of cycle 1 [ Time Frame: Baseline through 21 days; the end of cycle 1. ]
  • Part 2: Overall Survival (OS) [ Time Frame: Randomization through death due to any cause. Approximately 25 months. ]
    OS is defined as the time between the date of randomization and the date of death due to any cause.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 25 months. ]
    PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner.

  • Objective Response Rate [ Time Frame: Baseline through the end of study. Approximately 25 months. ]
    Objective response rate determined by radiographic disease assessments per RECIST v1.1, by investigator assessment.

  • Duration of Response [ Time Frame: Baseline through end of study. Approximately 25 months. ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.

  • Disease Control [ Time Frame: Baseline through end of study. Approximately 25 months. ]
    Disease control determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.

  • Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments [ Time Frame: Baseline through approximately 30 days post treatment discontinuation. Assessed after approximately 25 months. ]

Enrollment: 9
Study Start Date: June 2014
Study Completion Date: August 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110 plus docetaxel Drug: INCB039110
INCB039110 tablets administered orally at dose defined in the protocol for Part 1 of the study and the dose selected from Part 1 based on the data available for use in Part 2 of the study.
Drug: docetaxel
Administered as an intravenous infusion in the clinic at the frequency defined in the protocol for Part 1 of the study and the dose selected from Part 1 based on the data available for use in Part 2 of the study.
Placebo Comparator: Placebo plus docetaxel Drug: Placebo
Matching placebo tablets to be administered by mouth at dose defined in the protocol for Part 1 of the study and the dose selected from Part 1 based on the data available for use in Part 2 of the study.
Drug: docetaxel
Administered as an intravenous infusion in the clinic at the frequency defined in the protocol for Part 1 of the study and the dose selected from Part 1 based on the data available for use in Part 2 of the study.

Detailed Description:

This population will consist of subjects with stage IIIB, IV or recurrent NSCLC who have been previously treated. The study consists of two parts, Part 1 and Part 2. Part 1 is an open label, safety run-in, which is designed to confirm the safety and tolerability of INCB039110 in combination with docetaxel and to select a dose to be evaluated in Part 2. During Part 1 subjects will receive open label INCB039110 and docetaxel.

In Part 2 of the study, subjects will be randomized to receive either INCB039110 or placebo and docetaxel. The dose and frequency of INCB039110 and docetaxel administered will be determined from Part 1 of the study. INCB039110/placebo will be self-administered each day during the entire cycle. This part of the study will be conducted in a double-blind, randomized manner.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257619

Locations
United States, Arizona
Hot Springs, Arizona, United States
United States, California
Los Angeles, California, United States
United States, District of Columbia
Washington, D.C., District of Columbia, United States
United States, Florida
Orlando, Florida, United States
United States, Michigan
Detroit, Michigan, United States
United States, Mississippi
Pascagoula, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, North Carolina
Goldsboro, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Gettysburg, Pennsylvania, United States
Hershey, Pennsylvania, United States
United States, Rhode Island
Pawtucket, Rhode Island, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, Texas
Round Rock, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Amit Pande, M.D. Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02257619     History of Changes
Other Study ID Numbers: INCB 39110-203
Study First Received: September 26, 2014
Last Updated: July 3, 2017

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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2017