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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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14 March 2016 |
Main ID: |
EUCTR2009-012595-27-NL |
Date of registration:
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22/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 VERSUS STANDARD OF CARE CHEMOTHERAPY (PEMETREXED OR DOCETAXEL) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
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Scientific title:
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PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 VERSUS STANDARD OF CARE CHEMOTHERAPY (PEMETREXED OR DOCETAXEL) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS |
Date of first enrolment:
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22/06/2010 |
Target sample size:
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318 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012595-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Bulgaria
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Netherlands
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Poland
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic 2. Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as determined by an ALK break apart FISH assay and defined by an increase in the distance of 5’ and 3’ ALK probes or the loss of the 5’ probe 3. Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy. Patients must be considered appropriate candidates for additional chemotherapy with either single-agent pemetrexed or single-agent docetaxel Includes patients who received one prior platinum-based chemotherapy for treatment of de novo Stage IIIB/IV NSCLC. - Includes patients who have received one prior platinum-based chemotherapy in the adjuvant setting following surgical resection for early disease and whose disease has recurred within 6 months of completion of prior chemotherapy - Includes patients who received one prior platinum-based chemotherapy in combination with radiation therapy for Stage III locoregional disease and whose disease has recurred within 6 months of completion of prior chemotherapy - Includes patients who received 2 prior platinum-based chemotherapy regimens, if the first regimen was given as adjuvant therapy or was given in combination with radiation therapy for locally advanced disease - Includes patients who have received prior treatment with an EGFR tyrosine kinase inhibitor, such as erlotinib or gefitinib, providing these patients have also received only one prior platinum-based chemotherapy regimen as in one of the scenarios described above 4. Patients with brain metastases are eligible if treated and neurologically stable for at least 2 weeks and is not taking any medications contraindicated in Exclusion Criteria #12-14 5. Any prior chemotherapy or major surgeries must have been completed at least 4 weeks prior to initiation of study medication. Any prior radiation or minor surgeries/procedures must have been completed at least 2 weeks prior to the initiation of study medication. Any acute toxicity must have recovered to = Grade 1 (except alopecia) 6. Tumors must have measurable disease as per RECIST (version 1.1); 7. Female or male, 18 years of age or older (for patients enrolled in Japan: consent from a legally acceptable representative is required for all patients who are under 20 years old) 8. ECOG performance status 0-2 9. Adequate organ function as defined by the following criteria: Hepatic function - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST and ALT =5 x ULN if liver function abnormalities are due to underlying malignancy; however, for patients who if randomly assigned to Arm B must receive docetaxel, ALT and/or AST must not be > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN -Total serum bilirubin =1.5 x ULN however for patients who if randomly assigned to Arm B must receive docetaxel, total serum bilirubin must be = 1 x ULN Bone marrow function - Absolute neutrophil count (ANC) =1500/µL - Platelets =100,000/µL - Hemoglobin =8.0 g/dL Renal function - Creatinine clearance (based on modified Cockcroft-Gault formula) = 45 ml/min 10. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the t
Exclusion criteria: 1. Current treatment on another therapeutic clinical trial 2. Prior therapy specifically directed against ALK 3. Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease 4. Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. 5. Ongoing cardiac dysrhythmias of NCI CTCAE Grade =2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec 6. Previous treatment with PF-02341066 7. Patients who if randomly assigned to Arm B must receive pemetrexed and who have NSCLC with predominantly squamous cell carcinoma 8. Patients who if randomly assigned to Arm B must receive docetaxel and who have peripheral neuropathy with Grade > 2 9. Patients who if randomly assigned to Arm B must receive docetaxel and who have had a hypersensitivity reaction to medications formulated with polysorbate 80 10. [Deleted per Amendment #7] 11. Pregnancy or breastfeeding. 12. Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to amprenavir, atazanavir, clarithromycin, delavirdine, diltiazem, erythromycin, indinavir, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil, voriconazole, and grapefruit or grapefruit juice 13. Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, tipranavir, ritonavir, and St. John’s wort. 14. Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited aripiprazole, ergotamine, halofantrine, pimozide, triazolam, astemizole*, cisapride*, and terfenadine* (* withdrawn from U.S. market) 15. Prior malignancy (other than current NSCLC): patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer) within the last 3 years 16. For Japan only: patients who have following complications or symptoms: - Serious wound such as chronic wound, or grade =3 gastrointestinal ulcer - Serious gastrointestinal symptoms such as grade =3 diarrhea 17. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS MedDRA version: 12.0
Level: LLT
Classification code 10061873
Term: Non-small cell lung cancer
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Intervention(s)
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Product Name: Not Applicable Product Code: crizotinib Pharmaceutical Form: Tablet INN or Proposed INN: crizotinib CAS Number: 877399-52-5. Current Sponsor code: PF-02341066 Other descriptive name: IUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin- Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Name: Not Applicable Product Code: crizotinib Pharmaceutical Form: Tablet INN or Proposed INN: crizotinib CAS Number: 877399-52-5. Current Sponsor code: PF-02341066 Other descriptive name: IUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin- Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Alimta (pemetrexed) Product Name: Pemetrexed Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: pemetrexed CAS Number: 137281-23-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
Trade Name: Taxotere (docetaxel) Product Name: Docetaxel Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: docetaxel CAS Number: 114977-28-5 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 80-
Trade Name: Taxotere (docetaxel) Product Name: Docetaxel Pharmaceutical Form: Intravenous infusion INN or Proposed INN: docetaxel CAS Number: 114977-28-5 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 20-
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Primary Outcome(s)
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Main Objective: Primary Objective: •To demonstrate that PF-02341066 (Arm A) is superior to standard of care chemotherapy, pemetrexed or docetaxel (Arm B), in prolonging PFS in patients with advanced NSCLC whose tumors harbor a translocation or inversion event involving the ALK gene locus and who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based
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Primary end point(s): Primary Endpoint: ? PFS based on RECIST version 1.1 (confirmed by independent radiology review) Secondary Endpoints: ? 6-months and 1-year OS, OS, ORR (confirmed by independent radiology review), DCR at 6 and 12 weeks, DR ? Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities ? Plasma concentrations of PF-02341066 ? QTc ? Types of EML4-ALK fusion variants and ALK protein expression ? Plasma concentrations of soluble c-Met ectodomain and HGF scatter proteins ? TTD in patient reported pain, dyspnea, and cough ? HRQoL, lung cancer disease/treatment-related symptoms, and general health status
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Secondary Objective: Secondary Objectives: •To compare secondary measures of clinical efficacy including overall survival (OS), objective response rate (ORR), and disease control rate (DCR) between the two treatment groups, and evaluate duration of response (DR) •To assess the safety and tolerability of PF-02341066 compared to pemetrexed or docetaxel •To compare PRO of HRQoL, disease/treatment-related symptoms of lung cancer, and general health status in both treatment arms •To characterize the effects of PF-02341066 at therapeutic doses on QTc interval in this patient population •To determine PK in this patient population using POPPK methods and explore correlations between PK, response and/or safety findings •To explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript •To correlate modulation of soluble biomarkers to PK and outcome measures
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Secondary ID(s)
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A8081007
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2009-012595-27-GB
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Source(s) of Monetary Support
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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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