NSCLC (Non-small Cell Lung Carcinoma) Clinical Trial
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
Verified date | January 2018 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 9 |
Est. completion date | April 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). | Baseline through 21 days; the end of cycle 1. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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