Trial record 1 of 1 for:
Centus
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (AVANA)
This study is currently recruiting participants.
Verified July 2017 by Centus Biotherapeutics Limited
Sponsor:
Centus Biotherapeutics Limited
ClinicalTrials.gov Identifier:
NCT02810457
First Posted: June 23, 2016
Last Update Posted: July 24, 2017
Information provided by (Responsible Party):
Centus Biotherapeutics Limited
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Purpose
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
| Condition | Intervention | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: FKB238 (bevacizumab) Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 NSCLC in Combination of Paclitaxel and Carboplatin |
Resource links provided by NLM:
Further study details as provided by Centus Biotherapeutics Limited:
Primary Outcome Measures:
- Overall Response Rate (ORR) assessed as the proportion of subjects with a best overall response (BOR) of either Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
Secondary Outcome Measures:
- Progression-free Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
- Overall Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
- Duration Of Response [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
- Disease Control Rate (DCR) assessed as the proportion of subjects with a best overall response (BOR) of either Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
Other Outcome Measures:
- Adverse events (AEs) [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Vital signs [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Hematology [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Clinical chemistry [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Urinalysis [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Electrocardiogram [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Eastern Collaborative Oncology Group Performance Status [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Physical examination [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
- Proportion of patients developing Anti-drug antibodies (ADAs) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
- Serum trough concentration [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
| Estimated Enrollment: | 730 |
| Study Start Date: | June 2016 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FKB238 / paclitaxel / carboplatin
Drug: FKB238 15 mg/kg IV infusion on Day 1 of a 21-day cycle Drug: Paclitaxel 200 mg/m2 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles Drug: Carboplatin Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles
|
Drug: FKB238 (bevacizumab) Drug: Paclitaxel Drug: Carboplatin |
|
Active Comparator: Avastin / paclitaxel / carboplatin
Drug: Avastin 15 mg/kg IV infusion on Day 1 of a 21-day cycle Drug: Paclitaxel 200 mg/m2 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles Drug: Carboplatin AUC = 6.0 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles
|
Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin |
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 RECIST v1.1
- Adequate hematological, renal and liver function
- Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
- Life expectancy longer than 6 months
Exclusion Criteria:
- Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
- Any unresolved toxicities from prior systemic therapy
- Known sensitizing EGFR mutations or EML4-ALK translocation positive mutations
- Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
- Known hypersensitivity to any excipients of the Investigational Products (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 inclusion/exclusion criteria may apply.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810457
Contacts
| Contact: Clinical Trial Information | Clinical-Trials@centusbio.com |
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Sponsors and Collaborators
Centus Biotherapeutics Limited
Investigators
| Study Director: | Centus Biotherapeutics Limited | Centus Biotherapeutics Limited |
More Information
| Responsible Party: | Centus Biotherapeutics Limited |
| ClinicalTrials.gov Identifier: | NCT02810457 History of Changes |
| Other Study ID Numbers: |
FKB238-002 2015-004104-33 ( EudraCT Number ) |
| First Submitted: | June 3, 2016 |
| First Posted: | June 23, 2016 |
| Last Update Posted: | July 24, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Centus Biotherapeutics Limited:
|
Cancer Bevacizumab Carboplatin Paclitaxel |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Paclitaxel Albumin-Bound Paclitaxel Bevacizumab |
Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |