Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 April 2017 |
Main ID: |
EUCTR2013-004812-24-DE |
Date of registration:
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05/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2 Study of INCB039110 in combination with docetaxel in advanced Non–Small Cell Lung Cancer
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Scientific title:
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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 - INCB39110 with docetaxel in NSCLC |
Date of first enrolment:
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12/12/2014 |
Target sample size:
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172 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004812-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Canada
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European Union
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France
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Germany
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Hong Kong
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Hungary
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Ireland
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Korea, Republic of
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Information Centre
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Address:
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Rt 141 & Henry Clay Road
DE 19880
Wilmington
United States |
Telephone:
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18554633463 |
Email:
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RegAffairs@incyte.com |
Affiliation:
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Incyte Corporation |
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Name:
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Information Centre
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Address:
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Rt 141 & Henry Clay Road
DE 19880
Wilmington
United States |
Telephone:
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18554633463 |
Email:
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RegAffairs@incyte.com |
Affiliation:
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Incyte Corporation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
MedDRA version: 17.1
Level: PT
Classification code 10029522
Term: Non-small cell lung cancer stage IV
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.1
Level: PT
Classification code 10029521
Term: Non-small cell lung cancer stage IIIB
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.1
Level: PT
Classification code 10029515
Term: Non-small cell lung cancer recurrent
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Code: INCB039110 Pharmaceutical Form: Tablet Current Sponsor code: INCB039110 Other descriptive name: INCB039110 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: •To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS. •To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response. •To evaluate and compare disease control of INCB039110 in combination with docetaxel versus INCB039110 alone. •To evaluate and compare the safety and tolerability of INCB039110 in combination with docetaxel versus docetaxel alone.
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Main Objective: Safety Run-In Phase (Part 1): • To evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation. Randomized Phase (Part 2): • To evaluate and compare the OS of subjects with previously treated advanced or metastatic NSCLC when treated with INCB039110 in combination with docetaxel versus docetaxel alone.
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Primary end point(s): Safety run-in Phase (Part 1): - Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters. - Determination of a MTD (MTD is defined as the highest dose level tested that is considered tolerated on the basis of fewer than 3 DLTs in a cohort of up to 9 subjects) of INCB039110 in combination with docetaxel.
Randomized Phase (Part 2) - Overall survival determined from the date of randomization until death due to any cause.
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Timepoint(s) of evaluation of this end point: The primary endpoint is OS, defined as number of days from randomization to death. Once a total of 69 events has been observed, which is expected after an enrollment period of 12 months, and 5 months of follow-up after the last subject is randomized.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Secondary efficacy analysis will be conducted for the intent-to-treat population.
Progression-free survival will be determined from the randomization date until the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause if earlier.
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Secondary end point(s): •Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner.
•Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.
•Safety and tolerability through assessment of AEs and changes in safety assessments and laboratory parameters.
•Disease control as measured by the percentage of patients whose best response was not progressive disease (PD) (ie, complete response [CR], partial response [PR], or stable disease [SD] per RECIST v1.1). Stable disease will be included if it occurs at least 6 weeks after randomization.
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Secondary ID(s)
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2013-004812-24-IE
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INCB39110-203
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Source(s) of Monetary Support
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Incyte Corporation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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