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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30 April 2019 |
Main ID: |
EUCTR2015-004104-33-DE |
Date of registration:
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19/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluation of FKB238 and Avastin® in patients with advanced/recurrent non-squamous non-small cell lung cancer
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Scientific title:
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A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients with Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer in Combination of Paclitaxel and Carboplatin - AVANA |
Date of first enrolment:
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13/09/2016 |
Target sample size:
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730 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004104-33 |
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: yes Placebo: no 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): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Belarus
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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Croatia
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France
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Georgia
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Germany
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Greece
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Hungary
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Italy
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Japan
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Korea, Republic of
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Peru
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Philippines
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Poland
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Romania
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Russian Federation
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Serbia
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Spain
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Taiwan
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Thailand
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Turkey
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Ukraine
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United States
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Vietnam
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Contacts
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Name:
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Clinical Trial Information
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Address:
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1 Francis Crick Avenue
CB2 0AA
Cambridge
United Kingdom |
Telephone:
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NA |
Email:
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Clinical-Trial@centusbio.com |
Affiliation:
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Centus Biotherapeutics Limited |
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Name:
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Clinical Trial Information
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Address:
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1 Francis Crick Avenue
CB2 0AA
Cambridge
United Kingdom |
Telephone:
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NA |
Email:
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Clinical-Trial@centusbio.com |
Affiliation:
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Centus Biotherapeutics Limited |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Patients aged 18 years or older • Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease • Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC • Existence of at least 1 measurable lesion by response evaluation criteria • Adequate haematological, renal and liver function
Other inclusion criteria may apply. 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria: • Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumours and mixed adenosquamous carcinomas of predominantly squamous nature • Any unresolved toxicities from prior systemic therapy • Known sensitising EGFR mutations or EML4-ALK translocation positive mutations • Previous dosing with vascular endothelial growth factor (VEGF) inhibitor • Known hypersensitivity to active ingredients or any excipients of the IPs and combination chemotherapy • Use of prohibited concomitant medication • Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection • Fertile men or women of childbearing potential not using adequate contraception
Other exclusion criteria may apply.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer
MedDRA version: 20.0
Level: HLT
Classification code 10029664
Term: Non-small cell neoplasms malignant of the respiratory tract cell type specified
System Organ Class: 100000004864
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Intervention(s)
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Product Code: FKB238 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Current Sponsor code: FKB238 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Other descriptive name: Avastin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Main Objective: To demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR
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Timepoint(s) of evaluation of this end point: From randomisation to study treatment discontinuation
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Primary end point(s): Overall Response Rate (by Response Evaluation Criteria [RECIST] v1.1) assessed as the rate of the best response (complete response [CR] or partial response [PR])
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Secondary Objective: To compare FKB238 and EU-Avastin through: - Overall response rate at week 19 - Progression-free Survival - Overall Survival - Duration Of Response - Disease Control Rate To compare the safety of FKB238 and EU-Avastin To compare the ADAs produced by FKB238 and EU-Avastin To compare the serum trough concentration (Ctrough) of FKB238 and EU-Avastin
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Secondary Outcome(s)
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Secondary end point(s): • Overall response rate (ORR) (by RECIST v1.1) at week 19, defined as the rate of the best response of Complete Response (CR) or Partial Response (PR) assessed at week 19 • Progression-free Survival (PFS), defined as the time from randomisation to the first documented disease progression (PD) or death, whichever occurs first • Overall Survival (OS), defined as the time from randomisation to death from any cause • Duration Of Response (DOR), defined as the time from the first documented Partial Response (PR) or Complete Response (CR) (by RECIST v1.1) to the first documented objective PD or death, whichever occurs first • Disease Control Rate (DCR), defined as the rate of CR, PR, Stable Disease (SD) (=6 weeks) • Safety as evaluated through Adverse Events (AEs), vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram (ECG), Eastern Collaborative Oncology Group Performance Status (ECOG PS), and physical examination • Immunogenicity (presence of ADAs) • Pharmacokinetics (PK) (Ctrough)
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Timepoint(s) of evaluation of this end point: • PFS: from randomisation to the first documented disease progression (PD), death or data cut-off, whichever occurs first • OS: from randomisation to death from any cause or data cut-off • DOR: from the first documented Partial Response (PR) or Complete Response (CR) (by RECIST v1.1) to the first documented objective PD or death, whichever occurs first • DCR: the rate of CR, PR, Stable Disease (SD) (=6 weeks) • Safety: from signature of informed consent, up to and including 30-day follow-up after last dose of study treatment • Immunogenicity: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first • PK: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first
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Secondary ID(s)
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FKB238-002
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122990
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Source(s) of Monetary Support
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Centus Biotherapeutics Limited
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Ethics review
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Status: Approved
Approval date:
Contact:
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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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