| CTRI Number |
CTRI/2009/091/000441 [Registered on: 04/08/2009] |
| Last Modified On: |
11/01/2020 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the pharmacokinetic comparison of two formulations for Intravenous Infusion of Paclitaxel in Indain Patients with Metastatic Breast Cancer. |
|
Scientific Title of Study
|
An open label, balanced, randomized, two period, two treatment, two sequence, and two way crossover study to evaluate safety and pharmacokinetic comparison of intravenous infusion of paclitaxel Lipid Suspension and Taxol® in patients with Metastatic Breast Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 357-08 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Rajesh CN |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Clinical Trial Management - Lambda Therapeutic Research Ltd.
Lambda House , Opp. Gujarat High court, Plot No. 38, S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202022 |
| Email |
rajeshcn@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Netal Desai |
| Designation |
Manager, Medical Services |
| Affiliation |
Lambda Therapeutics Ltd. |
| Address |
Lambda Therapeutic Research Ltd
Lambda House , Opp. Gujarat High court, Plot No. 38, S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202022 |
| Email |
netaldesai@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Rajesh CN |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Clinical Trial Management - Lambda Therapeutic Research Ltd.
Lambda House , Opp. Gujarat High court, Plot No. 38, S.G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202022 |
| Email |
rajeshcn@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Limited
Chinubhai Centre, Ashram Road, Ahmedabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380009Phone: (079) 26576655; Fax: (079) 26578862 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GN Patel |
Jeevandip Hospital |
302, 3rd floor, AYUSH doctor house, Near Param Doctor House, Station to lal darwaja road, Near Resham Bhuvan-395003
Surat
GUJARAT |
02612413131
gnonco@gmail.com |
| Dr Chiramana Haritha |
M S Patel Cancer Centre |
Dept. of Medical Oncology, M S Patel Cancer Centre,Shree Krishna Hospital, Gokal Nagar-388325
Anand
GUJARAT |
02692222130
ritu80@rediffmail.com |
| Dr J K Singh |
Mahavir Cancer Sansthan |
Department of Medical Oncology, Phulwari Sharif-801505
Patna
BIHAR |
06122253956
drjksingh147@hotmail.com |
| Dr Kirushna Kumar |
Meeneakshi Mission Hospital and Rearch Centre |
Department of Medical Oncology, Meeneakshi Mission Hospital and Rearch Centre,Lake Area, Melur Road-625107
Madurai
TAMIL NADU |
09787713004
drkskk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethical Review Board, Meenakshi Mission Hospital and Research Centre |
Approved |
| Ethics Review Board, Mahavir Cancer Institute and Research Center |
Approved |
| Heart First Ethics Committee |
Approved |
| Human Research Ethics Committee of H.M. Patel Center for Medical Care & Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Metastatic Breast Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paclitaxel lipid suspension |
175 mg/m2 IV infusion over 3 hours |
| Comparator Agent |
Taxol® (Paclitaxel Injection of Bristol-Myers Squibb) |
175 mg/m2 IV infusion over 3 hours |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
- Female & > or =18 years and < 65 years of age and having a body mass index (BMI) at least 17 calculated as weight in kg/(height in meter)2 with histopathologically/cytologically confirmed metastatic breast cancer, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2, adequate bone marrow, renal and hepatic functions, recovery from any toxic effects incurred from previous chemotherapy as judged by the investiagator and with life expectancy of at least 3 months.
- The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures.
- For patient with child bearing potential: Patient should not be pregnant or nursing, having negative pregnancy test at screening, and must be using effective form of birth control measure during and for 1 month after study participation.
|
|
| ExclusionCriteria |
| Details |
- History of hypersensitivity to paclitaxel injection or other drugs containing polyoxyethylated castor oil. Like cyclosporine or teniposide
- Any cardiac conditions
- History of drug addiction within last 1 year
- History of brain metastasis
- Preexisting motor or sensory neurotoxicity of severity > or = grade 2 as defined by NCI criteria
- Serum bilirubin > 2 times ULN, or if SGOT and/or SGPT > 2 times ULN
- The neutrophil count < 1,500 cells/mm3 and platelet count < 100,000 cells/mm3
- HIV infection
- Any other condition that in investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
- Donation of blood (1 unit of 350 ml) within 90 days prior to receiving the first dose of study medicine
- Known existing uncontrolled coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterise the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in patients of metastatic breast cancer. |
Multiple time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients |
throughout the studyperiod |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to characterize the pharmacokinetic profile of paclitaxel with two formulations for intravenous infusion of paclitaxel in 16 Indian patients of metastatic breast cancer.
Secondary objective is to monitor the safety of the Indian patients who are exposed to the investigational products.
The investigational hypothesis is that the new formulation for paclitaxel infusion manufactured by Intas Pharmaceuticals Ltd. is bioequivalent to Taxol i.e. 90% confidence intervals for In-transformed pharmacokinetic parameters Cmax and AUC0-t falls within the acceptance range of 80.00-125.00 percentage for paclitaxel.
Both interventions will be given at the interval of 21 days.
After completion of study (two cycles) additional two cycles of paclitaxel injection will be administered to the patients for completing the compassionate use of a total four treatment cycles for each Indian patient.
The first patient is expected to be enrolled in 2nd week of August. |