CTRI/2015/03/005653 [Registered on: 25/03/2015] Trial Registered Retrospectively
Last Modified On:
19/05/2015
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Crossover Trial
Public Title of Study
A randomized, open label, multi centric, 2 treatment, 2 period, 2 sequence, single dose, crossover, BE study of Paclitaxel protein-bound particles for injectable suspension 100mg/vial and Abraxane 100mg/vial (Albumin bound Paclitaxel 260mg/m2) IV infusion in patients with metastatic breast cancer
Scientific Title of Study
A randomized, open label, multi centric, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial manufactured by Sindan Pharma for Actavis LLC, USA and Abraxane 100 mg/vial (Albumin bound Paclitaxel 260 mg/m2) intravenous infusion Abraxis BioScience LLC, New Jersey in patients with metastatic breast cancer
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ACTA/PAC/2013 Version 4 February 10, 2015
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Bhupesh SPednekar
Designation
Project Manager
Affiliation
Lotus Labs Pvt. Ltd
Address
Lotus House
# 07, Jasma Bhavan Road
Millers Tank Bed Area
Opp. Guru Nanak Bhavan
Vasanth Nagar
Bangalore
Bangalore KARNATAKA 560 052 India
Phone
42708400
Fax
Email
saravanan_g@lotuslabs.com
Details of Contact Person Scientific Query
Name
DrSharath Sekar Shivamogga
Designation
Medical advisor
Affiliation
Lotus Labs Pvt. Ltd
Address
Lotus House
# 07, Jasma Bhavan Road
Millers Tank Bed Area
Opp. Guru Nanak Bhavan
Vasanth Nagar
Bangalore
Bangalore KARNATAKA 560 052 India
Phone
08042708400
Fax
Email
sharath_ss@lotuslabs.com
Details of Contact Person Public Query
Name
DrSharath Sekar Shivamogga
Designation
Medical advisor
Affiliation
Lotus Labs Pvt. Ltd
Address
Lotus House
# 07, Jasma Bhavan Road
Millers Tank Bed Area
Opp. Guru Nanak Bhavan
Vasanth Nagar
Bangalore
KARNATAKA 560 052 India
Phone
08042708400
Fax
Email
sharath_ss@lotuslabs.com
Source of Monetary or Material Support
Actavis LLC
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
USA
Primary Sponsor
Name
Actavis LLC
Address
Morris Corporate Center III
400 Interpace Parkway,
Parsippany, NJ 07054 USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 9
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Singaraju Mallik
BIBI General Hospital and Cancer Centre
Room no. 308, Department of Radiation Oncology, 3rd floor, BIBI General Hospital and Cancer Centre,
16-3-991/1/C, Government Printing Press Road,
Malakpet, Hyderabad-500024,
Telangana, India. Hyderabad ANDHRA PRADESH
04024528144
drmallik.onco@gmail.com
Dr Gururaj Deshpande
City Cancer Centre
Department of Surgical Oncology, 1st floor, City Cancer Centre, 33-25-33, Suryarao Pet, Vijaywada-520002, Andhra Pradesh, India Krishna ANDHRA PRADESH
08662436661
drgururajdeshpande@gmail.com
Dr Krishnan
Dr. Rai Memorial Medical Centre
Department of Oncology, Basement floor, Dr. Rai Memorial Medical Centre,
No: 562, Century Plaza, Anna Salai,
Teynampet, Chennai-600061,
Tamilnadu, India Chennai TAMIL NADU
044-24349860
krishnan_dr@yahoo.com
Dr Arun Seshachalam
GVN Cancer Institute (a Unit of GVN Hospital)
Department of Medical Oncology, ground floor, GVN Cancer Institute (a Unit of GVN Hospital), No. 46, Singarathope, Trichy - 620 008. Tamil Nadu, India Tiruchirappalli TAMIL NADU
09626010005
drarunonco@gmail.com
Dr Vijay Bhaskar
Meenakshi Mission Hospital and Research Centre
Department of Oncology,
Meenakshi Mission Hospital and Research Centre,
Lake Area, Melur Road, Madurai-625107,
Tamilnadu, India. Madurai TAMIL NADU
91-452-4263000
drvijaybhaskar@gmail.com
Dr Minish Jain
Noble Hospital
Consultation OP room, 6th Floor, Department of Oncology,
Noble Hospital 153, Magarpatta City Road Hadapsar Pune 411013, Maharashtra, India Pune MAHARASHTRA
9823133390
minishjain009@gmail.com
Dr Ghanshyam Biswas
Sparsh Hospital and Critical Care
Consultation Room No. 1, Department of Surgical Oncology, Ground Floor, Sparsh Hospital and Critical Care A/407, Sahid Nagar, Bhubaneshwar 751007, Orissa, India. Khordha ORISSA
9937500878
drgbiswas@yahoo.com
Dr CT Sateesh
Sri Venkateshwara Hospital
Consultation Room, 3rd Floor, Department of Medical Oncology,
Sri Venkateshwara Hospital # 86, Hosur main road, Madiwala Bangalore 560068, Karnataka, India Bangalore KARNATAKA
9686679406
smohyderabad@gmail.com
Dr Lokanatha
Srinivasan Cancer Care Hospital
Consultation Room No. 1, Second Floor,
Srinivasan Cancer Care Hospital, 236/1, 2nd floor, Vijayshree Layout, Arekere, Bannerghatta Road, Bangalore 560076, Karnataka, India. Bangalore KARNATAKA
Abraxane 100 mg/vial (Albumin bound Paclitaxel) intravenous infusion Abraxis BioScience LLC, New Jersey
Dose- 260 mg/m2, Frequency- In every 21 days (1 cycle), Mode of Administration-IV
Duration of the trial- 8 months
Intervention
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial manufactured by Sindan Pharma for Actavis LLC, USA
Dose- 260 mg/m2, Frequency- In every 21 days (1 cycle), Mode of Administration-IV
Duration of the trial- 8 months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Female
Details
i. Female patients aged between 18 - 60 years of age (inclusive) with histological or cytological confirmation of diagnosis of breast cancer.
ii.Female patients with metastatic breast cancer (No known CNS metastasis) after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. If the patient is already receiving Paclitaxel, at least two more cycles of Paclitaxel should be required for completing the course of chemotherapy, for inclusion in the study.
iii. Life expectancy of more than 6 months as judged by the Investigator.
iv. ECOG (Eastern Cooperative Oncology Group) performance status of 2 or less.
v. Adequate renal function defined as Serum Creatinine ≤1.5 times ULN
vi. Previous chemotherapy and or radiotherapy should be completed 4 weeks prior to start of first IMP administration for the current study
vii. Previous hormonal treatment should be completely washed out prior to start of IMP administration
viii. Satisfactory medical assessment done by investigator to ensure that there are no clinically significant and relevant abnormalities (of medical history, physical examination and ECG, clinical or laboratory evaluation (haematology, biochemistry, serology and urinalysis). Patients must have Hemoglobin ≥ 9 gm/dl for inclusion in the study
ix. Postmenopausal women with amenorrhea for at least 12 consecutive months
x. Female patients of child bearing potential must agree to use one of the following contraceptive measures during and for at least three months after cessation of therapy:
a. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
b. IUD in place for at least 3 months.
c. Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 4 days following the last dose.
d. Abstinence
e. Other birth control methods deemed acceptable by the investigator
xi. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions
xii. Patient must have provided signed and dated Informed consent given in written form in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before initiating any study-related procedures
ExclusionCriteria
Details
i. History or presence of significant current or recurrent disease (other than breast cancer) that could affect the action or disposition of the investigational product, or clinical or laboratory assessments.
ii. History or presence of significant current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment (other than breast cancer) or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
iii. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease.
iv. Patients with medical conditions that preclude administration of chemotherapy [uncontrolled intercurrent illness like unstable angina, myocardial infarction (within 6 months prior to study entry), congestive heart failure, serious cardiac arrhythmias, uncontrolled diabetes, autoimmune disease, or any uncontrolled systemic disease (e.g. recurrent pleural effusion / ascites, active infections, patients with immune deficiency disorders) or patients already on immunosuppressive drugs] or any other significant co-morbid conditions as determined by the investigator (s).
v. Patients with liver impairment - serum transaminase levels (alanine transaminase [ALT] and/or aspartate transaminase [AST]) greater than 2.5 times the upper limit of normal (ULN) concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN
vi. Patients with absolute neutrophil count of < 1,500 cells/mm3 & platelet < 1,00,000 /mm3 during screening
vii. Serum albumin < 3 gm/dl
viii. Presence of Left ventricular ejection fraction (LVEF) of <50% as determined by Echocardiography (ECHO)/ Multiple Gated Acquisition scan (MUGA).
ix. Previous documented history of QTc prolongation with other medication or patient with congenital QT prolongation or patient with Patients with QTc ≥ 470 ms (where QTc based on Bazett’s correction method) or patient with any other significant cardiac disease.
x. Presence of left bundle branch block (LBBB) and with significant atrioventricular block (AV block).
xi. Current (within 2 weeks of the start of the study) or regular use of any medication (including over the counter [OTC], herbal or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessment.
xii. Clinical illness other than breast cancer, radiotherapy or any major surgery within 4 weeks before the start of the study.
xiii. Patients with known CNS metastasis.
xiv. Positive urine drug screening, HIV, VDRL/RPR, Hepatitis B & C tests.
xv. Patients with severe fluid retention e.g. pleural effusion, pericardial effusion or ascites.
xvi. Patients previously been randomized into this study and subsequently withdrawn
xvii. Known or suspected intolerance or Hypersensitivity to Paclitaxel or any of the excipients or any other taxane
xviii. Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study.
xix. Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period.
xx. Patient unable to be closely followed for social, Geographic or psychological reasons.
xxi. Patients who have taken medication that are either substrates or inhibitor/inducer of CYP3A4/CYP2C8 enzyme < 3 weeks prior to start of IP or require as concomitant medication
xxii. Patients with pre-existing sensory neuropathy of a severity > grade 3 as defined in National Cancer Institute Common Toxicity Criteria (CTC)
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC0-t and AUC0-∞
• The study duration for each patient will be of approximately 50 days (14 days of screening+21 days of washout including P-I dosing +15 days of follow up period)
To summarize the treatment emergent adverse events in patients
Throughout the study
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/03/2015
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a randomized, open
label, two way cross over, bioequivalence study comparing Paclitaxel
protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
manufactured by Sindan Pharma for Actavis LLC, USA and Abraxane 100 mg/vial (Albumin bound Paclitaxel)
intravenous infusion Abraxis BioScience LLC, New Jersey in Patients with metastatic breast
cancer. This study will be conducted in multi centre sites in India. The
primary objective of this study is to show bioequivalence of Paclitaxel
protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
manufactured by Sindan Pharma for Actavis LLC and Abraxane100 mg/vial (Albumin bound Paclitaxel)
intravenous infusion Abraxis BioScience LLC in patients with metastatic breast
cancer.
Secondary objective
is to summarize the treatment emergent adverse events in patients with metastatic
breast cancer.