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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: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2016/01/006522
Date of registration: 14-01-2016
Prospective Registration: Yes
Primary sponsor: Pfizer Limited
Public title: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous non small cell lung cancer.
Scientific title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER - N/A
Date of first enrolment: 22-02-2016
Target sample size: 798
Recruitment status: Closed to Recruitment of Participants
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13266
Study type:  Interventional
Study design:  Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
 
Phase:  Phase 3
Countries of recruitment
Argentina Australia Brazil Bulgaria Chile Croatia Czech Republic France
Germany Greece Hong Kong Hungary India Italy Japan Malaysia
Netherlands Peru Philippines Poland Romania Russian Federation Slovakia South Africa
Spain Taiwan Thailand Turkey Ukraine United States of America
Contacts
Name: Dr Seema Pai   
Address:  Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai, MAHARASHTRA,400051 400051 Mumbai, MAHARASHTRA India
Telephone: 08826422322
Email: Seema.Pai@pfizer.com
Affiliation:  Pfizer Limited
Name: Dr Seema Pai   
Address:  Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai,MAHARASHTRA,400051, India 400051 Mumbai, MAHARASHTRA India
Telephone: 08826422322
Email: Seema.Pai@pfizer.com
Affiliation:  Pfizer Limited
Key inclusion & exclusion criteria
Inclusion criteria: 1.Male and female patients age >=18 years of age, or >= age of consent in the region.

2.Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC) for which they had not received chemotherapy for metastatic disease.

3.Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.

4.At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

5.For patients with recurrent disease, at least 6 months must have elapsed since completing adjuvant or neoadjuvant treatment.

6.Patients must have had a baseline scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest, abdomen, and other disease sites, as clinically indicated, to assess disease burden performed within 28 days prior to randomization.

7.Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.

8.Screening laboratory values within the following limits (where deviation of up to 10% is acceptable for any single value if in the investigatorâ??s opinion the patient does not have an increased safety risk):

Bone Marrow Function

a.Absolute neutrophil count (ANC) >=1.5 x 109 cells/L (1500/mm3);

b.Platelet count >=100 x 109 cells/L (100,000/mm3);

c.Hemoglobin >=9.0 g/dL (90 g/L);



Renal Function

d.Serum creatinine <=1.5 x upper limit of normal (ULN);

e.Urine dipstick proteinuria <2+ (ie, either 0, trace, or 1+). If urine dipstick is >1+ then a 24 hour urine for protein must have demonstrated urinary excretion of <=500 mg of protein per day;



Liver Function

f.Total bilirubin <=1.5 x ULN ( <3 ULN if Gilbertâ??s disease);

g.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <= 3 x ULN (<= 5 x ULN if liver metastases are present).

9.Recovery (to Grade 1 or baseline) from all clinically significant adverse effects of prior therapies (excluding alopecia).

10.Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.

11.Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

12.Male and female subjects of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least 6 months after the last dose of assigned treatment (bevacizumab-Pfizer or bevacizumab-EU).

Female subjects who are not of childbearing potential (ie, meet at least 1 of the following criteria):

•Have undergone a documented hysterectomy and/or bilateral oophorectomy;

•Have medically confirmed ovarian failure; or

•Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratoryâ??s reference range for postmenopausal women.


Exclusion criteria: Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

1. Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.

2. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation.

3. Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.

4. History of other cancer within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ of the breast, cervical carcinoma in situ, or basal or squamous cell skin cancer.

5. Prior systemic therapy for metastatic disease.

6. History of hemoptysis (more than 2.5 mL per event) in the last 3 months or severe bleeding. Evidence of current thrombotic or bleeding disorders. Systemic anticoagulation or chronic therapy with prescription non-steroidal anti-inflammatory drugs (NSAIDs), aspirin more than 325 mg, or other non-selective NSAIDs above the maximum allowed over the counter (OTC) dose, and/or coagulation abnormalities (eg, INR more than 1.5 and aPTT greater than ULN within 1 week prior to randomization). [Some NSAIDs have effects on platelet function (see Prescribing Information for the specific NSAID). In the event that a patientâ??s NSAID therapy exceeds the maximum dose of OTC medication, the investigator should contact the Sponsor for approval of patient inclusion. Approval will be based on the type of NSAID therapy, the dose, and the patientâ??s other known risk factors.]

7. Medically uncontrolled hypertension or systolic blood pressure more than 150 mmHg or diastolic blood pressure more than 100 mmHg.

8. Peripheral motor or sensory neuropathy with value of more than or equal to 2.

9. Major surgery, radiotherapy, or any investigational agents, within 4 weeks before the administration of the first dose of study treatment. Planned major surgery during the treatment period.

10. Any unhealed wound or bone fracture.

11. Infection requiring a course of systemic anti-infective agents within 3 weeks prior to randomization. Patients must be off of antibiotics for 7 days.

12. Comorbidities that would increase the risk of toxicity as per the investigatorâ??s discretion.

13. Concurrent administration of other anticancer therapies. Bisphosphonate or Rank-Ligand inhibitor therapy for pre-existing bone metastases or osteoporosis is allowed.

14. Known central nervous system (CNS) metastases, as evidenced by appropriate scans, clinical symptoms, cerebral edema, and/or progressive growth.

15. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of more than or equal to 3, unstable angina, or myocardial infarction within 12 months before first dose of study treatment. Clinically significant cardiovascular disease, peripheral vascular disease, transient ischemic attack, cerebrovascular accident.

16. History of severe hypersensitivity reaction to any of the products to be administered during the study, including mammalian cell derived drug products, taxanes, bevacizumab, murine proteins, or excipients in their formulations.

17. Clinical contraindication to treatment with steroids preventing use as part of paclitaxel premed


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- NSCLC â?? Non Small Cell Lung Cancer
Intervention(s)
Intervention1: Bevacizumab-Pfizer(PF-06439535): Patients will be randomized to receive either bevacizumab-Pfizer or bevacizumab-EU in a 1:1 ratio. Dosing will be determined based on the body weight of the patient at the beginning of each 21-day cycle.
Bevacizumab-Pfizer and bevacizumab-EU will be administered once at the start of every 21-day cycle. The initial dose is 15 mg/kg delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be
administered over 30 minutes. If during the shortened infusions, infusion related reactions occur, the length of the infusion can be lengthened at the discretion of the clinician.
Bevacizumab-Pfizer or bevacizumab-EU will continue to be administered on Day 1 of every 3-week cycle after the chemotherapy has been discontinued. Bevacizumab-Pfizer or bevacizumab-EU will be administered until RECIST 1.1 defined disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, or withdrawal of consent occurs. No dose reduction is planned for bevacizumab-Pfizer orbevacizumab-EU.

Control Intervention1: Bevacizumab-EU(AVASTIN): Patients will be randomized to receive either bevacizumab-Pfizer or bevacizumab-EU in a 1:1 ratio. Dosing will be determined based on the body weight of the patient at the beginning of each 21-day cycle.
Bevacizumab-Pfizer and bevacizumab-EU will be administered once at the start of every 21-day cycle. The initial dose is 15 mg/kg delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolera
Primary Outcome(s)
Objective Response Rate (ORR), evaluating the best response achieved by Week 19 and subsequently confirmed by 6 weeks thereafter, inaccordance with Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1.

Timepoint: Every 6 weeks (±7 days) until Week 25 (based on date of randomization).

Secondary Outcome(s)
Safety characterized by type, incidence, severity, timing, seriousness,

and relationship to study therapy of adverse events, including cardiotoxicity and infusion-related reactions, and laboratory abnormalities;

Duration of response,1 year progression-free survival

rate and 1-year survival rate

Peak and trough bevacizumab-Pfizer and bevacizumab-EU

concentrations at selected cycles

Incidence of anti-drug (bevacizumab) antibodies, including neutralizing antibodiesTimepoint: 1 Year
Secondary ID(s)
B7391003
Source(s) of Monetary Support
Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States of America
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/07/2015
Contact:
Ethics Committee Mahatma Gandhi Cancer Hospital and Research Institute Institutional Review Board
Status: Approved
Approval date: 03/08/2015
Contact:
HCG- Central Ethics Committee
Status: Approved
Approval date: 10/08/2015
Contact:
Shatabdi Hospital Ethics Committee
Status: Approved
Approval date: 19/08/2015
Contact:
Institutional Ethics Committee Bhagwan Mahaveer Cancer Hospital and Research Centre
Status: Approved
Approval date: 07/09/2015
Contact:
Ethics Committee- Krishna Shalby Hospital
Status: Approved
Approval date: 12/09/2015
Contact:
Noble Hospital Institutional Ethics Committee
Status: Approved
Approval date: 19/09/2015
Contact:
Sahyadri Hospitals Ltd.Ethics Committee
Status: Not Approved
Approval date:
Contact:
Human Ethics Committee Regional Cancer Centre
Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee â?? 1,Tata memorial Hospital
Status: Not Approved
Approval date:
Contact:
The Ethics Committee, S.M.S Medical College and attached hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
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