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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17 July 2017 |
Main ID: |
EUCTR2014-000370-19-ES |
Date of registration:
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31/07/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2/3 clinical study to evaluate the safety and efficacy of the study medication CO-1686 compared to erlotinib in subjects with Non-Small Cell Lung Cancer
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Scientific title:
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TIGER-1: A Randomized, Open-label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) - TIGER-1 |
Date of first enrolment:
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26/10/2015 |
Target sample size:
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1200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000370-19 |
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: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Erlotinib
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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France
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Germany
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Hong Kong
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Israel
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Italy
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Korea, Republic of
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Spain
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Taiwan
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United States
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Contacts
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Name:
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Dr Lindsey Rolfe
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Address:
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Sheraton House, Castle Park
CB3 0AX
Cambridge
United Kingdom |
Telephone:
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900 811 335 |
Email:
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info@clovisoncology.com |
Affiliation:
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Clovis Oncology UK Ltd |
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Name:
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Dr Lindsey Rolfe
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Address:
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Sheraton House, Castle Park
CB3 0AX
Cambridge
United Kingdom |
Telephone:
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900 811 335 |
Email:
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info@clovisoncology.com |
Affiliation:
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Clovis Oncology UK Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent NSCLC 2. Documented evidence of a tumor with one or more activating EGFR mutations excluding exon 20 insertion 3. Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of planned randomization and have tissue available to send to sponsor lab or are able to undergo a biopsy during Screening and provide tissue to sponsor lab 4. Measureable disease according to RECIST Version 1.1 5. Life expectancy of at least 3 months 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 7. Age >= 18 years (in certain territories, the minimum age requirement may be higher; e.g., age >= 20 years in Japan and Taiwan) 8. Adequate hematological and biological function, confirmed by the following laboratory values e.g. Bone Marrow Function, Hepatic Function, Renal function and Electrolyte within normal range 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900
Exclusion criteria: 1. Documented evidence of an exon 20 insertion activating mutation in the EGFR gene 2. Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization 3. Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment -Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first day of study treatment, Cycle 1 Day 1 (C1D1) 4. Known pre-existing interstitial lung disease (ILD) 5. Brain metastases 6. Treatment with prohibited medications [e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment (except corticosteroids and megesterol acetate), or immunotherapy] =< 14 days prior to first day of study treatment, Cycle 1 Day 1 (C1D1) 7. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval if that treatment cannot be either discontinued or switched to a different medication (not known to affect QT interval) prior to C1D1 8.Prior treatment with EGFR TKIs, CO-1686 or other drugs that target mutant EGFR 9. Cardiac abnormalities or history 10. Non-study related surgical procedures =< 7 days prior to C1D1. In all cases, the patient must be sufficiently recovered and stable before treatment administration. 11. Females who are pregnant or breastfeeding 12. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of CO-1686 and 2 weeks after the last dose of erlotinib 13. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism) 14. Any other reason the investigator considers the patient should not participate in the 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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First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 18.0
Level: LLT
Classification code 10029514
Term: Non-small cell lung cancer NOS
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: CO-1686 Product Code: CO-1686 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not applicable CAS Number: 1446700-26-0 Current Sponsor code: CO-1686 Other descriptive name: CO-1686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125-
Product Name: CO-1686 Product Code: CO-1686 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not applicable CAS Number: 1446700-26-0 Current Sponsor code: CO-1686 Other descriptive name: CO-1686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Trade Name: Tarceva Product Name: Erlotinib Product Code: Erlotinib Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ERLOTINIB CAS Number: 183321-74-6 Other descriptive name: ERLOTINIB HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Trade Name: Tarceva Product Name: Erlotinib Product Code: Erlotinib Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ERLOTINIB CAS Number: 183321-74-6 Other descriptive name: ERLOTINIB HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Tarceva Product Name: Erlotinib Product Code: Erlotinib Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ERLOTINIB CAS Number: 183321-74-6 Other descriptive name: ERLOTINIB HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-
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Primary Outcome(s)
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Main Objective: To compare the antitumor efficacy of oral single-agent CO-1686 with that of erlotinib as measured by PFS, when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced/metastatic NSCLC
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Timepoint(s) of evaluation of this end point: From start of treatment until it is clear that no further clinical benefit can be achieved.
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Primary end point(s): PFS according to RECIST Version 1.1 as determined by investigator review (invPFS)
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Secondary Objective: - To compare secondary measures of clinical efficacy ORR, DR,and OS following treatment with CO-1686 versus erlotinib - To assess PFS, ORR, DR, and OS in patients with baseline T790M mutations based on central allele-specific polymerase chain reaction (PCR) EGFR mutation assay - To assess quality of life (QOL) using the patient-reported outcomes (PRO) of European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13), the Dermatology Life Quality Index (DLQI), and the EQ-5D instrument in patients receiving CO-1686 versus erlotinib ? To evaluate safety and tolerability of CO-1686 versus erlotinib in patients with advanced/metastatic NSCLC whose tumors have EGFR-activating mutations ? To determine PK of CO-1686 in this patient population using population PK (POPPK) methods and explore correlations between PK, exposure, response, and/or safety findings
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: From start of treatment until it is clear that no further clinical benefit can be achieved.
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Secondary end point(s): - ORR and DR according to RECIST 1.1 as determined by investigator review, and OS - invPFS, ORR, DR, and OS in patients with baseline T790M mutations confirmed by central EGFR mutation assay - Change from baseline in QOL as measured using the PRO of EORTC QLQ-C30, EORTC QLQ-LC13, the DLQI, and the EQ-5D following treatment with CO-1686 versus erlotinib - Treatment-emergent AEs, laboratory abnormalities and ECG abnormalities - Plasma PK parameters for CO-1686 based on sparse sampling
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Secondary ID(s)
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2014-000370-19-DE
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CO-1686-022
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Source(s) of Monetary Support
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Clovis Oncology, Inc.
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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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