| CTRI Number |
CTRI/2014/06/004668 [Registered on: 13/06/2014] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Bioequivalence study comparing Gemcitabine injection (Manufactured by: Intas Pharmaceuticals Ltd.) to the reference listed drug Gemzar injection (Eli Lilly and Company) in patients with Pancreatic or Ovarian Cancer |
|
Scientific Title of Study
|
A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, single dose bioequivalence study comparing Gemcitabine injection (Manufactured by: Intas Pharmaceuticals Ltd.) to the reference listed drug Gemzar injection (Eli Lilly and Company, Indianapolis, IN 46285, USA) in patients with Pancreatic or Ovarian Cancer |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 311-13,Version 01 Dated 06 Jun 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheejith K |
| Designation |
Project manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202021 |
| Email |
Sheejith@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath K |
| Designation |
AGM |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202021 |
| Email |
manjunathk@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath K |
| Designation |
AGM |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202020 |
| Fax |
07940202021 |
| Email |
manjunathk@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Intas Pharmaceuticals Ltd,
2nd Floor, Chinubhai Center,
Ashram Road, Ahmedabad
380-009, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipti Rani Samanta |
Acharya Harihar Regional Cancer Centre |
Department of Medical Oncology,Medical Road, Mangalabag,
Cuttack-753007
Cuttack
ORISSA |
9437032728
diptiranisamanta@rediffmail.com |
| Dr M Gopichand |
City Cancer Centre |
Consulting Room, Ground Floor, # 33-25-33
Ch. Venkatya Krishnayya Street, Suryaraopet
Vijayawada- 520002
Krishna
ANDHRA PRADESH |
9885256059
mgopichand@yahoo.com |
| Dr Rajnish Nagarkar |
Curie Manavta Cancer Center |
Consulting Room,Ground Floor, Opp.Mahamarg Bus Stand,Mumbai Naka-422004
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Ananda Selvakumar |
Meenakshi Mission Hospital & Research Centre |
"Department of Radiation Oncology Radiation & Clinical Oncologist,
Lake Area, Melur Road,Madurai -625 107
Madurai
TAMIL NADU |
9824333759
drask81@yahoo.co.in |
| Dr Jayanti Patel |
Nirmal Hospital Pvt Ltd |
"Room No. 109, First Floor,
Ring Road, Civil Street, Near Kadiwala School-395002
Surat
GUJARAT |
9825121347
pateldrjayanti@gmail.com |
| Dr K C Lakshmaiah |
Srinivasam Cancer Care Hospitals India Pvt. Ltd. |
Medical Oncology, #236/1, Vijayashree Layout,
Arekere, Bannerghatta Main Road-560076
Bangalore
KARNATAKA |
9448055949
kcluck@gmail.com |
| Dr Tanveer Maksud |
Unique Hospital- Multispecialty & Research Institute |
Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002
Surat
GUJARAT |
9909918887
tanveermaksud@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Acharya Harihar Regional Cancer Centre Institutional Ethics committee,Dr Dipti Rani Samanta |
Approved |
| Ethics Committee,Dr. Tanveer Maksud |
Approved |
| Institutional Ethics committee Meenakshi Mission Hospital & Research Centre,Dr. Ananda Selvakumar |
Approved |
| Institutional Ethics committee,Dr. M. Gopichand |
Approved |
| Manavta Clinical Research Institute, Professional Ethics Committee,Dr. Rajnish Nagarkar |
Approved |
| Nirmal Hospital Pvt Ltd Ethics committee, Dr. Jayanti Patel |
Approved |
| Srinivasam Cancer Care Hospitals - IEC,Dr. K C Lakshmaiah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gemcitabine Injection Concentrate-1gm/10 ml |
For Ovarian Cancer:
Dose- 1000mg/m2,
Frequency- Day 1 and 8 of each 21 day cycle,
Mode of Administration- IV,
Duration of treatment- Up to 6 treatment cycles.
For Pancreatic Cancer:
Dose- 1000mg/m2,
Frequency- Once weekly,
Mode of Administration- IV,
Duration of treatment- Up to 7 weeks.
|
| Comparator Agent |
Gemzar® Injection powder, lyophilized, 1 gm/vial |
For Ovarian Cancer:
Dose- 1000mg/m2,
Frequency- Day 1 and 8 of each 21 day cycle,
Mode of Administration- IV,
Duration of treatment- Up to 6 treatment cycles.
For Pancreatic Cancer:
Dose- 1000mg/m2,
Frequency- Once weekly,
Mode of Administration- IV,
Duration of treatment- Up to 7 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Able to give written informed consent for participation in the trial.
2. Male and female patients between the ages of 18 and 65 years.
3. Patients with Histo-pathologically or through Fine Needle Aspiration Cytology (FNAC) confirmed
 Locally Advanced (non-resectable Stage II or Stage III) or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Gemcitabine as first line treatment)
‘OR’
 Pancreatic cancer patients previously treated with 5-FU
‘OR’
 Advanced Ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy (Gemcitabine in combination with Carboplatin)
4. Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
5. Patients if already on Radiotherapy, a gap of at least one week shall be maintained between the last day of radiotherapy and the day of screening
6. Patients with life expectancy of at least 2 months
7. Able to comply with study requirement in opinion of Principal Investigator.
8. Adequate hepatic, renal and hematopoietic function.
9. ECOG Performance Status- 0, 1 or 2
10. In case of female patient the serum pregnancy test at screening visit must be negative. |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity reaction to Gemcitabine and any ingredient of the formulation.
2. Use of any recreational drugs or history of drug addiction.
3. History of psychiatric disorders.
4. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
5. Known case of HIV infection.
6. Pregnant or breast-feeding women.
7. The receipt of an investigational drug or product, or participation in a drug research study within a period of 60 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
8. Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
9. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile of the sponsor’s test formulation relative to that of reference formulation in patients and to assess the bioequivalence |
Blood samples will be collected at following time points:
Pre-infusion (within 60 minutes prior to infusion), 5, 15 and 30 min during the infusion and 5 min, 10 min, 20 min, 0.5 hrs, 0.75 hrs, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 6 hrs, 8 hrs and 10 hrs post-infusion (total 16 samples) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product |
Screening, Day 0 (check in for period I), Day 07 (check in for period II), End of study. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
17/06/2014 |
| 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="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Gemcitabine injection is a cytotoxic drug. It would
not be appropriate to conduct this study on healthy volunteers. Therefore the
bioequivalence study is proposed to be carried out on patients of Pancreatic or
Ovarian cancer, who in the opinion of their treating physicians are candidates
for Gemcitabine injection therapy. A sample size of 44 patients would
be sufficient to establish bioequivalence between formulations with adequate
power. Primary Objective: To characterize the pharmacokinetic profile of the
sponsor’s test formulation relative to that of reference formulation in
patients and to assess the bioequivalence Secondary Objective:
To monitor the safety of the patients,
who are exposed to the Investigational Medicinal Product |