| CTRI Number |
CTRI/2009/091/000214 [Registered on: 19/05/2009] |
| Last Modified On: |
17/07/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study safety and effects of P276-00 in combination with Gemcitabine in treatment of pancreatic cancer . |
Scientific Title of Study
Modification(s)
|
A Phase I/II study to evaluate safety and efficacy of P276-00 in combination with Gemcitabine in patients with cancer of pancreas (Acronym: SAVIOR). |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| P276-00/28/08 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrAjay Mehta |
| Designation |
|
| Affiliation |
|
| Address |
entral India Cancer Research Institute, 11, Shankar Nagar, West High Court Road, Nagpur - 440 010
entral India Cancer Research Institute, 11, Shankar Nagar, West High Court Road, Nagpur - 440 010
Nagpur
MAHARASHTRA
440010
India |
| Phone |
09949385000 |
| Fax |
|
| Email |
ajayonco@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Himanshu Parikh |
| Designation |
|
| Affiliation |
Vice President- Clinical Research (R & D) |
| Address |
Piramal Life Sciences Limited, 1, Nirlon Complex,
Off Western Express Highway,Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02230818600 |
| Fax |
912230818703 |
| Email |
himanshu.parikh@piramal.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjeev C Hegde |
| Designation |
General Manager- Clinical Development |
| Affiliation |
|
| Address |
Piramal Healthcare Limited
9th Floor, R-Tech Park,
Nirlon Complex,
Off. Western Express Highway,
Goregaon East,
Mumbai, Maharashtra 400 063
India
Piramal Healthcare Limited
9th Floor, R-Tech Park,
Nirlon Complex,
Off. Western Express Highway,
Goregaon East,
Mumbai, Maharashtra 400 063
India
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02230275245 |
| Fax |
|
| Email |
sanjeev.hegde@piramal.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Piramal Life Sciences Limited Mumbai. |
|
Primary Sponsor
Modification(s)
|
| Name |
Piramal Life Sciences Limited |
| Address |
Nirlon complex,Off Western Express Highway,Goregaon(East), Mumbai- 400063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Ravi Kumar Saxena |
Global Hospital, Lakdi-Ka-Pool, Hyderabad-500004, India. |
,-500004
Hyderabad
ANDHRA PRADESH |
9949385000
|
| Dr Raj Nagarkar |
Curie Manavata Cancer Centre, Opp. Mahamarya Bus Stand, Mumbai Naka, Nashik- 422 004, Maharashtra |
,-422 004
Nashik
MAHARASHTRA |
9823061929
drrajnagarkar@yahoo.com |
| DrAmol Bapaye |
Deenanath Mangeshkar Hospital & Research Centre,Erandwane,Pune-411004 |
,-411004
Pune
MAHARASHTRA |
9822053654
amolbapaye@vsnl.com |
| Dr.Ajay Mehta |
entral India Cancer Research Institute, 11, Shankar Nagar, West High Court Road, Nagpur - 440 010 |
,-440 010
Nagpur
MAHARASHTRA |
ajayonco@hotmail.com |
| Dr. J S Rajkumar |
Lifeline Mutispecilaity Hospital, Perungudi Chennai - 600096 |
,-600096
Chennai
TAMIL NADU |
4442454545- ext 752
|
| Dr. Kirushna Kumar |
Meenakshi Mission Hospital & Reasearch Centre. Lake Area. Melur. Madurai-625107 |
,-625107
Madurai
TAMIL NADU |
9842113003
drksak@yahoo.com |
| Dr.Anita Ramesh |
Sri RamaChandra Medical Centre, No1, Ramachandra Nagar, Porur, Chennai- 600 116 |
,-600 116
Chennai
TAMIL NADU |
9840758567
anitachandra100@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Central India Cancer Research Institute, Nagpur - 440 010 |
Approved |
| Curie Manavata Cancer Centre, Nashik- 422 004, Maharashtra |
Approved |
| Deenanath Mangeshkar Hospital & Research Centre, Pune-411004 |
Approved |
| Global Hospital, Lakdi-Ka-Pool, Hyderabad-500004 |
Approved |
| Lifeline multispeciality hospital, chennai 600096, Tamil Nadu |
Approved |
| Meenakshi Mission Hospital & Reasearch Centre, Lake Area. Melur. Madurai-625107 |
Approved |
| Sri RamaChandra university, Porur, Chennai- 600 116 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Newly diagnosed inoperable locally advanced or metastatic infiltrating ductal adenocarcinoma of pancreas. , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Gemcitabine |
Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m 2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each. |
| Comparator Agent |
Nil |
Nil |
| Intervention |
P276-00 |
P276-00 will be administered as an intravenous infusion in 200 ml 5% dextrose over 30 min from days 1 to 5 per 21 day cycle at a starting dose of 100 mg/m2/day. Subsequent dose escalations will be as follows:- 140 mg/m 2/day (level 2) x 5 q 3 weeks185 mg/ m 2/day (level 3) x 5 q 3 weeks. Treatment will be given for 6 cycles. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Histologically or cytologically confirmed diagnosis of infiltrating ductal adenocarcinoma of pancreas. 2. Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas. 3.Locally advanced inoperable pancreatic cancer. 4. Patients of either sex, aged > or = 18 years.5. Karnofsky performance status of > or = 60%. 6. Adequate bone marrow reserve: white blood cell (WBC) count > or = 4 x 109/l, Absolute neutrophil count (ANC) > or = 1.5 x 109/l, platelets > or =100 x 109/l, hemoglobin > or = 10 g/dl.7. Adequate liver function: bilirubin < or = 1.5 times the upper normal value, ALT/AST/ alkaline phosphatase less than 3 times the upper normal value (unless due to liver metastases in which case bilirubin less than 3 times the upper normal value, ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit). 8. Adequate renal function: creatinine < or = 1.5 times the upper normal value.9. If female a)Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of at least 2 approved contraceptive methods (at least one should be a barrier method) during and for 4 weeks after stopping the study treatment. b) Negative urine beta HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.10. Additional inclusion criterion only for part B: Patient should satisfy at least one of the following criteria on cycle 1 day 1:a) Karnofsky performance status of 60 or 70 b)Baseline analgesic consumption of > or = 10 morphine equivalent per day c) Baseline pain intensity score of > or = 20 mm |
|
| ExclusionCriteria |
| Details |
1. Inability / unwillingness to give consent
2. Pregnant or breast feeding women
3. Brain metastasis (active or inactive)
4. Serious concomitant systemic disorders including, but not limited to active infection, congestive heart failure, cardiac arrhythmia, psychiatric illness etc that are incompatible with the study (at the discretion of the investigator)
5.Patients known to be suffering from infection with HIV,Tuberculosis,Hepatitis C or Hepatitis B.
6. Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment or who have not recovered (to grade 1) from adverse effects of the investigational agent received prior to this period.
7. Patients with QTc 450 msec on 12-lead standard electrocardiogram (ECG)
8. Major surgery within 2 weeks prior to protocol
treatment
9. Radiotherapy to 10% of bone marrow
10. Patients with clinically significant 3rd space fluid
1.accumulation (ascites, pleural effusion)
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas. |
At the end of study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate pharmacokinetic parameters of P276-00. |
At the end of study |
| To evaluate exploratory biomarkers associated with use of P276-00 and Gemcitabine. |
At the end of study |
| To characterize toxicities of P276-00 in combination with Gemcitabine. |
At the end of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="23"
Sample Size from India="23"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/06/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study is an open label multicenter trial to evaluate safety and efficacy of P276-00 in combination with Gemcitabine in subjects with locally advanced or metastatic pancreatic cancer. Primary objective in part A is to determine maximum tolerated dose (MTD) of P276-00 in combination with Gemcitabine and in part B to evaluate efficacy of this combination in subjects with locally advanced or metastatic pancreatic cancer. In part A cohort of 3 subjects will be enrolled at starting dose level of P276-00 which is 100 mg/m2/ day to be given intravenously (IV) from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. If this dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till MTD of P276-00 in combination with Gemcitabine is determined. In part B ten subjects will be evaluated at this MTD of P276-00 in combination with Gemcitabine to evaluate for efficacy. Dose of Gemcitabine will be same in both parts of the study which is 1000mg/m2 over 30mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. Subjects will be treated for six cycles of P276-00 in combination with Gemcitabine or until evidence of disease progression or unacceptable toxicity. Safety evaluations will be performed at regular intervals by means of record of vital parameters, physical examination and laboratory investigations for hematology and biochemistry. Efficacy assessment will be performed by means of weekly record of pain intensity, analgesic consumption, change in weight and performance status for evaluation of clinical benefit response and by means of CT scans at the end of every 2 cycles for evaluation of tumor response by RECIST (Response Evaluation Criteria in Solid Tumors) |