Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments incb039110, placebo, docetaxel
Phase phase 2
Targets JAK, JAK1
Sponsor Incyte Corporation
Start date June 2014
End date February 2016
Trial size 150 participants
Trial identifier NCT02257619, INCB 39110-203

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
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
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.
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 25 months.
Objective Response Rate
time frame: Baseline through the end of study. Approximately 25 months.
Duration of Response
time frame: Baseline through end of study. Approximately 25 months.
Disease Control
time frame: Baseline through end of study. Approximately 25 months.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.