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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

Information source: Biocad
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: Bevacizumab (Drug); Paclitaxel (Drug); Carboplatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Biocad

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Overall response rate

Area under the curve after the first test drug administration

Secondary outcome:

Complete response rate

Partial response rate

Stabilization rate

Progression rate

Relative number (%) of chemotherapy cycles, postponed due to adverse events (AE)

Treatment discontinuation rate due to AE

Occurrence and titer of anti-bevacizumab antibodies

Cmax

Tmax

T1/2

AE incidence and severity

AEs grade 3-4 incidence

minimal serum bevacizumab concentration

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

metastatc 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

Locations and Contacts

Brest Regional Clinical Dispensary, Brest, Belarus

Gomel Regional Clinical Oncology Dispensary, Gomel, Belarus

Grodno Regional Clinical Hospital, Grodno, Belarus

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk, Belarus

HCG Bangalore Institute of Oncology, Bangalore 560027, India

M.S.Ramaiah Memorial Hospital, Bangalore 560054, India

Narayana Hrudayalaya Hospitals, Bangalore 560099, India

Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk 163045, Russian Federation

Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk 454000, Russian Federation

State-financed Health Institution "Chelyabinsk Region Clinical Oncology Dispansary", Chelyabinsk, Russian Federation

State Healthcare Facility "Kursk Regional Oncology Dispensary", Kursk 305035, Russian Federation

State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health", Moscow Region 143423, Russian Federation

Federal State Institution "Moscow Institute of Cancer Research named after P.A. Hertsen" Ministry of Health of Russian Federation, Moscow 194044, Russian Federation

Institution of Russian Academy of Medical Sciences "Russian Cancer Research Center named after N.N. Blokhin", Moscow 115478, Russian Federation

Murmansk Regional Oncology Dispensary, Murmansk 183047, Russian Federation

Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center", Nizhny Novgorod 603006, Russian Federation

State Healthcare Facility "Nizhny Novgorod Regional Oncology Dispensary", Nizhny Novgorod, Russian Federation

City Clinical Hospital №1, Novosibirsk 630047, Russian Federation

Regional State Health Institution "Orlov Oncology Dispansary", Orel 302020, Russian Federation

State Health Institution "Region Oncology Dispansary", Penza 440071, Russian Federation

Perm Region Oncology Dispensary, Perm 614066, Russian Federation

Federal Government Budgetary Institution "Rostov Institute of Cancer Research" of Ministry of Health of Russian Federation, Rostov-on-Don 314019, Russian Federation

Saint Petersburg City Clinical Oncology Center, Saint Petersburg 197022, Russian Federation

State-financed Health Institution "Samara Region Clinical Oncology Dispansary", Samara 443031, Russian Federation

Oncology Dispensary 2, Sochi 354057, Russian Federation

St. Petersburg Research and Practice Center for Secondary Care in Oncology, St. Petersburg 197758, Russian Federation

St. Petersburg State Medical University n.a. I. P. Pavlov, St. Petersburg 197022, Russian Federation

Military Medical Academy named after S.M. Kirov, St.Petersburg, Russian Federation

N.N.Petrov Oncology Research Center, St.Petersburg 197758, Russian Federation

Russian scientific center of radiology and surgery technologies, St.Petersburg, Russian Federation

State-financed Health Institution "Stavropol Region Clinical Oncology Dispansary", Stavropol 355047, Russian Federation

Volgograd District Oncology Dispensary №1, Volgograd 400138, Russian Federation

Volgograd Regional Oncology Dispensary №3, Volgograd 404130, Russian Federation

State Health Institution "Voronezh Region Clinical Oncology Dispansary", Voronezh 394000, Russian Federation

Donetsk City Oncology Dispensary, Donetsk, Ukraine

Donetsk Regional Antitumor Center, Donetsk, Ukraine

Kharkiv Regional Clinical Oncology Center, Kharkiv, Ukraine

Kryvyi Rih Oncology Dispensary, Kryvyi Rih, Ukraine

Lviv State Regional Cancer Diagnostic and Treatment Center, Lviv, Ukraine

City Hospital № 2, Makiivka, Ukraine

Poltava Regional Clinical Oncology Dispensary, Poltava, Ukraine

Zakarpatskyi Clinical Oncology Dispensary, Uzhhorod, Ukraine

Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia, Ukraine

Zaporizhia Regional Clinical Oncology Dispensary, Zaporizhia, Ukraine

Additional Information

Starting date: October 2012
Last updated: February 2, 2015

Page last updated: August 20, 2015

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