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)
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| ClinicalTrials.gov Identifier: NCT02810457 |
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Recruitment Status :
Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : July 3, 2018
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Sponsor:
Centus Biotherapeutics Limited
Information provided by (Responsible Party):
Centus Biotherapeutics Limited
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: FKB238 (bevacizumab) Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 731 participants |
| 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 |
| Study Start Date : | June 2016 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: FKB238 (bevacizumab) Drug: Paclitaxel Drug: Carboplatin |
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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
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Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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
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Sponsors and Collaborators
Centus Biotherapeutics Limited
Investigators
| Study Director: | Centus Biotherapeutics Limited | Centus Biotherapeutics Limited |
| Responsible Party: | Centus Biotherapeutics Limited |
| ClinicalTrials.gov Identifier: | NCT02810457 History of Changes |
| Other Study ID Numbers: |
FKB238-002 2015-004104-33 ( EudraCT Number ) |
| First Posted: | June 23, 2016 Key Record Dates |
| Last Update Posted: | July 3, 2018 |
| Last Verified: | February 2018 |
Keywords provided by Centus Biotherapeutics Limited:
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Cancer Bevacizumab Carboplatin Paclitaxel |
Additional relevant MeSH terms:
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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 |