Clinical trial NCT02257619: Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NSCLC (Non-small Cell Lung Carcinoma)
Keywords: Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Baseline through 21 days; the end of cycle 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: Pascagoula
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Goldsboro
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Gettysburg
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Spartanburg
country: United States
state: South Carolina
city: Round Rock
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Amit Pande, M.D.
role: STUDY_DIRECTOR
References: