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A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Biocad
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT01763645
First received: December 27, 2012
Last updated: August 31, 2016
Last verified: August 2016
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Purpose
BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Avastin. Also study includes pharmacokinetics assessment.
| Condition | Intervention | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Bevacizumab Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | International Multicenter Randomized Double Blind Phase III Trial Comparing Safety and Efficacy of BCD-021 (CJSC BIOCAD, Russia) and Paclitaxel + Carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and Paclitaxel + Carboplatin in Inoperable or Advanced Non-squamous Non-small-cell Lung Cancer (NSCLC) Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Biocad:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: Day 127 ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Area Under the Curve After the First Test Drug Administration [ Time Frame: up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h) ]primary outcome measure for pharmacokinetics (PK) substudy
Secondary Outcome Measures:
- Complete Response Rate [ Time Frame: Day 127 ]secondary outcome measure for efficacy evaluation
- Partial Response Rate [ Time Frame: Day 127 ]secondary outcome measure for efficacy evaluation
- Stabilization Rate [ Time Frame: Day 127 ]secondary outcome measure for efficacy evaluation
- Progression Rate [ Time Frame: Day 127 ]secondary outcome measure for efficacy evaluation
- Occurrence of Anti-bevacizumab Antibodies [ Time Frame: Day 1 (before the drug administration), Day 15, 64 and 127 ]Secondary outcome measure for immunogenicity assessment
| Enrollment: | 138 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BCD-021 (CISC BIOCAD)
BCD-021 is a product code for bevacizumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Drug: Bevacizumab
Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
Other Names:
Drug: Paclitaxel
Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally)
Other Name: Taxacad
Drug: Carboplatin
Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).
|
|
Active Comparator: Avastin (F. Hoffmann-La Roche Ltd)
In this arm patients will receive 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
|
Drug: Bevacizumab
Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
Other Names:
Drug: Paclitaxel
Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally)
Other Name: Taxacad
Drug: Carboplatin
Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent;
- Newly diagnosed histologically or cytologically confirmed NSCLC excluding squamous NSCLC (mixed cancer types should be classified according to the prevalent cell type);
- IIIb or IV stage of NSCLC (TNM classification version 6);
- Age ≥ 18 years and age ≤ 75 years (both inclusive);
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, (not declining within 2 weeks prior to the first dose of investigational product);
- Life expectancy - 12 weeks or more from the moment of randomization;
- Presence of at least 1 measurable tumour with a size not less than 1 cm (revealed with CT slice thickness not more than 5 mm), as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, no ascites, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only lesion;
- Patients should be able to follow the Protocol procedures (according to Investigator's assessment);
- Patients must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 6 months after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization, or patients who are postmenopausal (documented) for the past 2 years. Reliable contraceptive measures include two methods of contraception, including one barrier method
Exclusion Criteria:
- Squamous NSCLC;
- Proven coagulopathy, clinically significant hemorrhage in the past including nasal hemorrhage;
- absolute neutrophil count <1500/mm3;
- Platelets <100 000/mm3;
- Hemoglobin < 90 g/L;
- Creatinine level ≥1.5 mg/dL;
- Bilirubin level ≥1.5 × upper limit of normal (ULN);
- Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN (≥5 × ULN for patients with liver metastases);
- Alkaline phosphatase level ≥5 × ULN;
- Current therapeutic anticoagulation treatment, aspirin (more than 325 mg/day), nonsteroidal anti-inflammatory drugs, antiplatelet agents or protracted treatment with these drugs less than 1 month before entering the study;
- Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medical correction methods (low salt diet, physical exercise);
- Any previous anticancer therapy (chemotherapy, radiation therapy , surgery etc.) of metastatic NSCLC;
- Radiation or hormone therapy within 21 days prior to randomization;
- Major surgery 28 days before inclusion into the study;
- Previous antiangiogenic therapy;
- Hypersensitivity to taxanes, platinum agents, recombinant murine proteins, contrast agents, premedication agents specified by Protocol (dexamethasone, diphenhydramine, ranitidine) or excipients of investigational products;
- NSCLC metastases in central nervous system excluding metastases non-progressing without glucocorticosteroids within 4 weeks before inclusion into the trial;
- Cardiovascular system pathology (CHF stage III-IV according to New York Heart Association (NYHA) classification);
- Pregnancy or lactation;
- Conditions limiting patient's adherence to Protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);
- Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0;
- Simultaneous participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;
- Any other concomitant cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;
- Acute or active chronic infections;
- Hepatitis C virus, hepatitis B virus, HIV, or syphilis infections;
- Obstacles in intravenous administration of study drugs
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01763645
Show 44 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763645
Show 44 Study Locations
Sponsors and Collaborators
Biocad
More Information
Additional Information:
| Responsible Party: | Biocad |
| ClinicalTrials.gov Identifier: | NCT01763645 History of Changes |
| Other Study ID Numbers: |
BCD-021-02 |
| Study First Received: | December 27, 2012 |
| Results First Received: | March 30, 2016 |
| Last Updated: | August 31, 2016 |
Keywords provided by Biocad:
|
NSCLC bevacizumab pharmacokinetics |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms 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 |
ClinicalTrials.gov processed this record on September 21, 2017