A Phase 2 Study of INCB039110 in combination with docetaxel in advanced Non-Small Cell Lung Cancer

Phase 1

• Conditions: Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.; MedDRA version: 17.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004812-24-ES
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-03
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

-Male or female, 18 years or older.
-Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV or recurrent.
-mGPS of 1 or 2 as defined below:
-mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ? 35 g/L
-mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L.
-Radiographically measurable or evaluable disease.
-Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease (not including neoadjuvant and/or adjuvant therapy with some exceptions).
-Prior systemic regimens must include a platinum based therapy. Investigational agents used in combination with standard platinum therapies are allowed.
-Tumors with driver mutations (EGFR mutation positive or ALK fusion oncogene positive) are allowed provided they also had prior treatment with a tyrosine kinase inhibitor (TKI).
-Maintenance therapy after first-line chemotherapy is allowed provided that the maintenance therapy did not include docetaxel or other taxane.
-Subjects who completed a platinum-containing regimen as adjuvant, neoadjuvant, or part of a course of chemoradiation therapy within the 6 months before screening are allowed.
-Prior treatment of advanced or metastatic disease with immune targeted therapy is allowed.
-Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

-Received prior treatment with a taxane.
-Chronic or current active infectious disease requiring systemic
antibiotics, antifungal, or antiviral treatment.-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 months prior to study entry, defined as:
-No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
-Asymptomatic and off all corticosteroids and anticonvulsants for at least 3 months prior to study entry.
- Grade 3 peripheral neuropathy.
-Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
-Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
If the subject has any of the following, they are excluded.
-Absolute neutrophil count < 1.5 × 109/L.
-Platelet count < 100 × 109/L.
-Hemoglobin < 9 g/dL (transfusion are permitted to achieve baseline hemoglobin level.)
-ALT/AST > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
-Alkaline phosphatase >2.5 x ULN.
- Subjects with ALT or AST elevation > ULN AND alkaline phosphatase > ULN.
-Total bilirubin > ULN.
-Creatinine clearance <50 mL/min measured or calculated by Cockroft-Gault equation or glomerular filtration rate (GFR) < 50 mL/min/1.73 m2 as calculated using modification of diet in renal disease (MDRD).
-Currently receiving therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin therapy after 1 week or 5 half-lives, whichever is longer.
-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 non-invasive malignancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified