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-DE
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-05
• Last Update Posted: 3 April 2017

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.
- Measurable lesions may be in the field of prior radiation; however, there must be at least a 4-week period between the last radiation treatment and demonstration of interval progression of the lesion compared with the baseline scan documenting disease status for the lesion to be considered measurable.
- Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease (not including neoadjuvant and/or adjuvant therapy except as noted below).
- 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.
= 3 weeks or 5 half-lives (whichever is longer) have elapsed from the completion of previous systemic therapy regimen (including maintenance therapy or immunotherapy) prior to the initiation of therapy and subjects must have recovered or be at a new stable baseline from any related toxicities prior to dosing.
- 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

1. Received prior treatment with a taxane.
2. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
3. 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:
a. No evidence of new or enlarging CNS metastasis or new neurological symptoms
attributable to CNS metastases.
b. Asymptomatic and off all corticosteroids and anticonvulsants for at least 1 month prior to study entry.
4. Peripheral neuropathy = Grade 3.
5. 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.
6. 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:
a. ANC < 1.5 × 109/L.
b. Platelet count < 100 × 109/L.
c. Hemoglobin < 9 g/L (transfusion are permitted to achieve baseline hemoglobin level.)
d. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
e. Alkaline phosphatase (ALP) > 2.5 × ULN.
f. Subjects with ALT or AST elevation > ULN and ALP > ULN.
g. Total bilirubin > ULN.
h. Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation or GFR < 50 mL/min/1.73 m2 as calculated using modification of diet in renal disease (MDRD).
7. Significant, concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
8. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
9. Concurrent 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 study treatment after 1 week or 5 half-lives, whichever is longer.
10. Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days before first dose of study treatment.
11. 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.
12. Known HIV infection, or HBV or HCV viremia or at risk for HBV reactivation. HBV DNA and HCV RNA must be undetectable. At risk for HBV reactivation is defined as HBSAg positive or anti-HBc antibody positive.
13. Pregnant or actively breastfeeding women.
14. Unwilling to be transfused with blood components.
15. Known hypersensitivity to any of the active substances or any of their excipients, including a JAK inhibitor or docetaxel.

Study & Design

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