| CTRI Number |
CTRI/2009/091/000506 [Registered on: 09/09/2009] |
| Last Modified On: |
30/08/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Imatinib In Adjuvant GIST |
|
Scientific Title of Study
|
A multi-center, single arm, Phase II study of adjuvant imatinib mesylate (glivec®) in patients following the resection of primary gastrointestinal stromal tumor (GIST) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSTI571BIC08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Manish Mistry |
| Designation |
Medical Director |
| Affiliation |
|
| Address |
Novartis India Limited
Sandoz House, 5th Floor, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958303 |
| Fax |
02224954112 |
| Email |
mahish.mistry@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Manish Mistry |
| Designation |
Medical Director |
| Affiliation |
|
| Address |
Novartis India Limited
Sandoz House, 5th Floor, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958303 |
| Fax |
02224954112 |
| Email |
manish.mistry@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharmaceuticals AG Basal Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis India Ltd |
| Address |
Sandoz House, 1st floor,
Shivsagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai 400 018.
India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Harsh Dua |
Indraprastha Apollo Hospital |
Sarita Vihar,,Mathura Road-110076
New Delhi
DELHI |
01126925858
01141677024
drharshdua@yahoo.co.in |
| Dr. Chaitanyanad Koppiker |
Jehangir Hospital & Research Center |
Jehangir Clinical Development Center,Jehangir Hospital Premises, 32 Sassoon Road-411001
Pune
MAHARASHTRA |
02026059318
02026059319
Chaitanyanand Koppiker <koppiker@gmail.com> |
| Dr. Suresh Advani |
S. L. Raheja Hospital |
Raheja Rugnalaya Marg,Mahim (W), -400016
Mumbai
MAHARASHTRA |
02224445526
02224442486
shadvani2000@yahoo.com |
| Dr. Chirag Desai |
Vedanta Institute of Medical Sciences |
Hemato-oncology Clinic,Stadium Commerce College Road, Navrangpura,-380009
Ahmadabad
GUJARAT |
91796673 6673
917966736677
chiragdesai.oncology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of Heart Care Clinic |
Approved |
| Ethics Committee On Clinical Trial |
Approved |
| Hirabai Cowasji Jehangir Medical Research Institute And Jehangir Clinical Development Center Ethics Committee |
Approved |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Primary Gastrointestinal Stromal Tumor (GIST), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Imatinib |
400mg |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Histologically proven diagnosis of primary GIST (without peritoneal or distant metastasis) with positive immunostaining for KIT (CD117);
2. Undergone complete gross resection of a primary GIST within 70 days prior to enrollment (includes R0 (negative microscopic margins) and R1 (positive microscopic margins);
3. Intermediate and high risk patients based on Corless criteria
4. Patient must be 18 years of age or older
5. WHO performance status 0 or 1 (Appendix 1)
6. Patient must have a post-operative CT scan with IV and PO contrast or MRI (optional) with contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to registration.
7. Patient must have the following post-operative laboratory values confirmed within 14 days prior to registration:
a. Creatinine ≤ 1.5 times the institution ULN (upper limit of normal)
b. WBC ≥ 2,000/mm3
c. Platelets ≥ 100,000/mm3
d. Total Bilirubin ≤ 1.5 times the institution ULN.
NOTE: Patients with elevated bilirubin secondary to Gilbert?s disease are eligible to participate in the study.
e. AST ≤ 2.5 times the institution ULN
f. ALT ≤ 2.5 times the institution ULN
g. Female of childbearing potential must have negative serum pregnancy test.
NOTE: Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of reproductive potential.
8. Patient or the patient?s legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
9. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration (non-US sites are exempt from HIPAA regulations).
10. If patient is a cancer survivor, ALL of the following criteria apply:
a. Patient has undergone potentially curative therapy for all prior malignancies.
b. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone).
c. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
|
|
| ExclusionCriteria |
| Details |
1. Patient has received post-operative chemotherapy.
2. Patient has received post-operative radiation therapy.
3. Patient has received post-operative investigational treatment.
4. Patient has received prior therapy with imatinib, or any other molecular targeted or biological therapy.
5. Patient has had an active infection requiring antibiotics within 14 days prior to registration.
6. Patient has objective evidence of residual disease on the postoperative CT scan or MRI (optional) of the abdomen or pelvis.
7. Patient, if female and breastfeeding. NOTE: It is not known whether imatinib or its metabolites are excreted in human milk. However, in lactating female rats administered 100mg/kg, a dose approximately equal to the maximum clinical dose of 800mg/day based on body surface area, imatinib and /or its metabolites were extensively excreted in milk. It is estimated that approximately 1.5% of a maternal dose is excreted into milk, which is equivalent to a dose to the infant of 30% the maternal dose per unit body weight. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breastfeeding while taking imatinib.
8. Patient has New York Heart Association Class 3 or 4 cardiac disease (Appendix 3)
9. Patient is taking full dose warfarin. NOTE: The use of mini-dose warfarin (1 mg orally per day) for prevention of central line-associated deep venous thrombosis is permitted.
10. Presence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Recurrence Free Survival Rate in patients with resected primary GIST who are
treated with adjuvant imatinib for a duration of 2 years |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To compare Recurrence Free Survival, Overall Survival, and Time to
Recurrence of patients with resected primary GIST who are treated
with adjuvant imatinib for a duration of 2 years with historical data
- To assess the safety of imatinib given as adjuvant therapy for 2
years in patients with resected primary GIST |
2 Years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
08/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/09/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Number patients proposed to be recruited from India is 10.
Tentative date of enrollment will in August. |