CTRI/2011/06/001837 [Registered on: 28/06/2011] Trial Registered Prospectively
Last Modified On:
18/06/2015
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the safety and efficacy of ON 01910.Na in combination with gemcitabine in patients with previously untreated Metastatic pancreatic cancer
A Phase III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
04-22(AGICC 11PAN01)
Protocol Number
NCT01360853
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Suresh Hariram Advani
Designation
Director, Department of Oncology
Affiliation
Address
Director, Department of Oncology
Jaslok Hospital & Research Centre 15, Dr. G. Deshmukh Marg,
City: Mumbai
State: Maharashtra
Postal Code: 400026
Country: India
Amrita Institute of Medical Sciences and Research Centre, Cochin
Professor and Chief Consultant of Medical oncology,
Amrita Institute of Medical Sciences and Research Centre,
Amrita lane, Ponekkara P.O., Edapally,
Cochin- 68204, Kerala, India
Ernakulam KERALA
Basavatarakam Indo-American Cancer Hospital & Research Institute, Hyderabad
Senior Consultant Medical Oncologist
Basavatarakam Indo-American Cancer Hospital & Research Institute,
Road No. 14, Banjara Hills,
Hyderabad-500034, Andhra Pradesh, India
Hyderabad ANDHRA PRADESH
Grant Medical Foundation, Ruby Hall Clinic,
New Cancer Building,
3rd Floor, 40, Sassoon Road
City: Pune
State: Maharashtra
Postal Code: 411001
Country: India.
Pune MAHARASHTRA
020-66455495 020-26124529 minishjain009@gmail.com
Dr Suresh Hariram Advani
Jaslok Hospital & Research Centre
Jaslok Hospital & Research Centre
15, Dr. G.Deshmukh Marg, Mumbai 400026, India
Mumbai MAHARASHTRA
Associate Professor, Department of Radiotherapy,
Regional Cancer Centre
Medical College Campus,
Thiruvananthapuram -695001, Kerala, India Thiruvananthapuram KERALA
Cancer Specialist and Chemotherapist,Shatabdi Superspeciality Hospital,
Suyojit City Centre, Opp. Mahamarg Bus Stand, Mumbai Naka
Nashik-422005, Maharashtra, India
Nashik MAHARASHTRA
Ethics Committee Lifeline Multispeciality Hospital 5/639, Old Mahabalipuram Road Perungudi, Chennai- 600096 Tamil Nadu, India
Approved
Ethics Committee , Jaslok Hospital & Research Centre , 15, Dr. Deshmukh Marg, Mumbai , 400026, India
Approved
Ethics Committee V.S Hospital. 13, East Spurtank Road, Chetpet Chennai - 600031 Tamil Nadu, India
Approved
Human Ethics Committee, Regional Cancer Centre, Medical College Campus, Trivendrum-695001, Kerala, India
Approved
Institutional Ethics Committee Poona Medical Research Foundation 40, Sassoon Road Pune- 411001 Maharashtra, India
Approved
Institutional Ethics Committee Chittaranjan National Cancer Institute, 37,S.P. Mukherjee Road, Kolkata - 700020
Approved
Institutional Ethics Committee Ethics Committee Office, Room No. 6, Administrative Block, Basement, Hero DMC Heart Institute, Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab, India.
Approved
Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre, Amrita lane, Ponekkara P.O., Edapally, Cochin- 68204, Kerala, India
Approved
Institutional Ethics Committee, Indo American Cancer Institute & Research Centre, Road No 14, Banjara Hills, Hyderabad -500 034, Andhra Pradesh, India
Approved
Institutional Review Board Mahatma Gandhi Cancer Hospital & Research institute, 1/7 MVP Colony, Visakhapatnam- 530017 Andhra Pradesh, INDIA
Approved
Institutional Review Board, Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai 400012
Approved
Shatabdi Hospital Ethics Committee, Shatabdi Superspeciality Hospital, Suyojit City Centre, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik-422005, Maharashtra, India
Gemcitabine 1000mg/m2 weekly for 3 weeks of 4 weeks cycle (on day 1, 8 & 15 of the 4 week cycle)
Route of Administration: Intravenous
Intervention
Gemcitabine 1000mg/m2 +
ON 01910. Na 1800mg/m2
Gemcitabine 1000mg/m2 weekly for 3 weeks of 4 weeks cycle (on day 1, 8 & 15 of the 4 week cycle)
+
ON 01910. Na 1800mg/m2 twice weekly for 3 week cycle (on day 1, 4, 8, 11, 15 & 18 of the 4 week cycle)
Route Of Administration: Intravenous
1. Patients at least 18 years old with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
2. Patients must have received no prior chemotherapy for pancreatic cancer.
3. Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥ 15 mm in the short axis.
4. ECOG Performance Status of 0, 1, or 2.
5. Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL, with a minimum calculated glomerular filtration rate (GFR) of 40 mL/min.
6. Patients must have adequate liver function as defined by total bilirubin ≤ 2.0 mg/dL and transaminase levels no higher than 3.0 times the institutions upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN.
7. All patients must have a serum albumin ≥ 3.0 g/dL.
8. Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥ 1,500/mm3, a platelet count ≥ 100,000/mm3, and hemoglobin 9 g/dL.
9. Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease).
10. Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients. Male patients with female partners with reproductive potential will utilize birth control methods (e.g., condom use) while participating in this trial;
11.Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin pregnancy test at Screening.
12.Willing to adhere to the prohibitions and restrictions specified in this protocol.
13.Patient must have signed an informed consent document.
ExclusionCriteria
Details
Patients with any of the following will not be enrolled in the study:
1. Patients with unresectable locally advanced disease without evidence of disease elsewhere;
2. Life expectancy of less than 12 weeks;
3. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension or seizure disorder;
4. Active infection not adequately responding to appropriate therapy.
5. Symptomatic or clinically evident ascites.
6. Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia (e.g., previous syndrome of inappropriate antidiuretic hormone hypersecretion [SIADH], chronic diuretic use, etc.)
7. Female patients who are pregnant or lactating.
8. Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
9. Evidence of brain metastases. A CT scan or magnetic resonance imaging (MRI) of the brain should be obtained in patients with symptoms suggestive of brain metastases;
10. Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of an investigational agent, chemotherapy, radiotherapy, or immunotherapy.
11. Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Overall Survival Time
This is the time from randomization to death of patient from any cause.
ON 01910.Na Population Pharmacokinetics for all patients in Arm A at pre-dose, 1 hour after starting the ON 01910.Na infusion, and just before the end of the ON 01910.Na infusion
On Cycle 1 Day 1 and Cycle 1 Day 15
Full ON 01910.Na and gemcitabine pharmacokinetics in a subset of 10 patients in the combined treatment group only
•predose,i.e.,before starting gemcitabine infusion
•15min after starting gemcitabine infusion
•30min,immediately before ending gemcitabine infusion
•45min after starting ON01910.Na infusion
•60min after ON01910.Na infusion start
•2hr30min,immediately before ending ON01910.Na infusion
•2hr45min, 3hr, 3hr30min, 4hr30min,6hr30min and 10hr30min after ending ON01910.Na infusion
Total Sample Size="400" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a randomized, controlled study for comparing the safety and efficacy of Gemcitabine alone versus ON 01910.NA in combination with Gemcitabine previously untreated Metastatic pancreatic cancer. The study will be conducted at three sites in India and also conducted in USA. The primary objective of study is to compare the Overall survival in two arms and Secondary objectives are to compare the Progression Free Survival time, Objective Response Rate, Safety and Quality of life in two arms. Additional secondary objectives are Pharmacokinetics in treatment group and Biomarker analysis on archival tissue.