| CTRI Number |
CTRI/2009/091/000568 [Registered on: 05/08/2009] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A Dose tolerability and Efficacy Study of RX-0201 plus Gemcitabine in Metastatic Pancreatic Cancer |
Scientific Title of Study
Modification(s)
|
A Dose tolerability and Efficacy Study of RX-0201 plus Gemcitabine in Metastatic Pancreatic Cancer |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| RX-0201-P2-A-07 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director, Clinical Project Management |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
Associate Director, Clinical Project Management
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 607
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shubhangi Desai |
| Designation |
Head Clinical Operations - Asia Pacific |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 610
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
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Source of Monetary or Material Support
Modification(s)
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Primary Sponsor
Modification(s)
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| Name |
Rexahn Pharmaceuticals Inc |
| Address |
9620 Medical Center Drive, Suite 100, RockvilleMD 20850, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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|
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Countries of Recruitment
|
India
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr TP Sahoo |
Jawaharlal Nehru Cancer Hospital |
Jawaharlal Nehru Cancer Hospital and Research Centre,
Idgah Hills,
Bhopal-462001
Bhopal
MADHYA PRADESH |
917552738325
tarini73@rediffmail.com |
| Dr Krishnaprasad |
Kasturba Medical College |
N. G. Road,
Ambedkar Circle, Attavar,
Mangalore-575001
Bangalore
KARNATAKA |
08242425092
drkrishnaprasad@hotmail.com |
| Dr P Ravi Mohan |
King George Hospital |
Dept. of Medicine, New Block,
King George Hospital,
Andhra Medical College,
Visakhapatanam,
A.P-530002
Visakhapatnam
ANDHRA PRADESH |
918916667205
oncoravi@rediffmail.com |
| Dr Kirushna Kumar |
Meenakshi Mission Hospital and Research Centre |
Department of Medical Oncology,
Meenakshi Mission Hospital and Research Centre, Lake Area,
Melur Road,
Madurai, 625020
Madurai
TAMIL NADU |
914522586353
drkskk@yahoo.com |
| Dr D C Doval |
Rajiv Gandhi Cancer Institute and Research Centre |
Rajiv Gandhi Cancer Institute and Research Centre
D-10, Sector-V, Rohini
Delhi- 110085
New Delhi
DELHI |
911127051037
dcdoval@gmail.com |
| Dr Sajeed Rahuman |
Regional Cancer Centre |
Post Box- 2417,
Thiruvananthapuram - 695 011
Kerala
Thiruvananthapuram
KERALA |
914712443498
sajerose@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethical Review Board, Meenakshi Mission Hospital and Research Centre, Madurai |
Approved |
| Human Ethics Committee, Regional Cancer Centre, Thiruvananthapuram |
Approved |
| Institutional Ethics Committee, Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal |
Approved |
| Institutional Ethics Committee, Kasturba Medical College, Manglore |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatanam |
Approved |
| Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre, Delhi |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Comparator Agent |
Gemcitabine |
Dose : 1000 mg/msquare Duration : 30 min IV infusion on Day 1, Day 8 and Day 15 followed by 1 week rest (1 Cycle duration is 28 days) |
| Intervention |
RX-0201 |
Dose : 250 mg/msquare/day
Duration : Continuous IV infusion for 14 days followed by 7 days of rest ( 1 Cycle duration is 21 days) |
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Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who:
1. Provide written informed consent prior to the initiation of study procedures.
2. Are greater than 18 years of age
3. Have metastatic pancreatic cancer.
4. Have at least a measurable lesion by RECIST criteria.
5. Have a Karnofsky Performance Status of greater than 70.
6. Have at least a 6-month life expectancy as assessed by the investigator.
7. Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD).
8. Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug. The agreed method of birth control by sunject will be discussed and documented in the source document of subject during the screening phase of the study. |
|
| ExclusionCriteria |
| Details |
Subjects who:
1. Are unwilling or unable to provide informed consent.
2. Are unwilling or unable to comply with the requirements of the protocol.
3. Have been treated with another investigational agent.
4. Have any of the following screening laboratory values:
i. Hemoglobin less than 8.0 grams/deciliter (g/dL)
ii. Absolute neutrophil count (ANC) less than 1500/microliter
iii. Platelet count less than 100,000/microL
iv. Serum creatinine greater than 1.5 x the institutional upper limit of normal (IULN) creatinine.
v. Serum bilirubin greater than 1.5 X IULN
vi. Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis)
vii. Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis)
viii. Have a prothrombin time greater than 1.25 x IULN on screening laboratory assessments.
ix. Lack Lewis antigens
x. HCV, and HBsAg positive Subjects
xi. CA 19-9 less than 75 U/ml
5. Have received either warfarin or heparin treatment within 21 days before Day 1 (the first day of dosing; except for line dose of prophylactic warfarin or heparin).
6. Have a history of brain cancer (primary or metastatic).
7. Have a history of an active hematologic malignancy within the past 2 years.
8. Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
9. Have a serious infection requiring intravenous antibiotic therapy during screening.
10. Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period. |
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Method of Generating Random Sequence
Modification(s)
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Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Tolerability
2. Survival |
1. At Every Cycle (14 day cycle).
2. At 2,4 & 6 months from the last completed cycle. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Response(Assessed by RECIST) |
NIL |
| Molecular Markers (VEGF, AKT and CA 19-9) |
NIL |
| Toxicity/ Safety using CTCAE v. 3.0 (safety) and Vital Signs, ECG, Clinical Laboratory Assessment (Safety) |
NIL |
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Target Sample Size
Modification(s)
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Total Sample Size="35"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
16/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
21/09/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This Study is an Open Lable, Single Arm dose tolerability and efficacy study od RX-0201 plus Gemcetabine in Metatatic Pancreatic Cancer. This study comprise of the Safety and the Efficacy phase. In the Safety phase, RX-0201 (250 mg/m2/Day) plus Gemcitabilne (1000 mg/m2) will be administered for 2 cycles as a combination therapy. In the Efficacy phase, RX-0201 (250 mg/m2/day) plus Gemcitabine (1000 mg/m2) will be administered for 4 cyclels as a combination therapy. The study will be conducted in 2 centers in US and 7 centers in India. The primary outcome of the study is Tolerability and Survival. The secondary outcome of the study is Response (assessed by RECIST), Molecular Markers (VEGF, AKT and CA 19-9) and Toxicity/Safety using CTCAE v. 3.0 (safety) and Vital Signs, ECG, Cllinical Laboratory Assessment (safety)
Target Sample size for India- It will be basically be competitive recruitment & we at this point targeting to recruit 15 patients |