| CTRI Number |
CTRI/2009/091/001086 [Registered on: 04/02/2010] |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Oprelvekin in patients with in prevention and treatment of chemotherapy induced thrombocytopenia in adult cancer patients. |
Scientific Title of Study
Modification(s)
|
An open label, multi-centric, single arm, non-randomized,
prospective study to assess the efficacy and safety of
Recombinant Human Interleukin-11 (Oprelvekin) in
prevention and treatment of chemotherapy induced
Thrombocytopenia in adult cancer patients |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| KL-LUPOPV-0060909 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Apurva A Patel |
| Designation |
|
| Affiliation |
|
| Address |
The Gujarat Cancer & Research Institute,
NCH Campus,Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
91-79-22688000 |
| Fax |
91-79-22685490 |
| Email |
gcri.clinicaltrials@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
Medical Monitor |
| Address |
4Th Floor, Laxmi Tower, B Wing, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-6640-2222 |
| Fax |
|
| Email |
alokchaturvedi@lupinpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Lupin Limited, "C" Wing, 4th Floor, Laxmi Towers
Bandra Kurla Complex, Bandra (E),
Not Applicable
N/A
400 051
India |
| Phone |
91-22-66402248 |
| Fax |
|
| Email |
alokchaturvedi@lupinpharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Lupin Limited |
| Address |
4Th Floor, Laxmi Tower, B Wing, Bandra Kurla Complex, Bandra East, Mumbai - 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Karmic Labs PvtLtd |
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Col Dr Prakash G Chitalkar |
BATRA Hospital |
D-2 BHMRC Housing,No.1 Tughlakabad Institutinal Area,-110062
New Delhi
DELHI |
09818580256
prakashchitalkar@gmail.com |
| Dr. Anand Pathak |
Cancer Care Clinic |
5th floor,Vasant Sheela Tower,Lokmat Square, Dhantoli-440 012
Nagpur
MAHARASHTRA |
09665019156
k_madankar@rediffmail.com |
| Dr. Ajay Mehta |
Central India Cancer Research Institute |
11, Shankar Nagar,-440 010.
Nagpur
MAHARASHTRA |
0982380081
suchitraonco@hotmail.com |
| Dr. Apurva Patel |
Gujarat Cancer & Research Institute |
Clinical Trial Wing, Gujarat Cancer & Research Institute, ,Civil Hospital Campus, Asarwa-380016
Ahmadabad
GUJARAT |
079 - 22688419
gcri.clinicaltrials@yahoo.co.in |
| Dr. Umesh Takalkar |
Kodlikeri Memorial Hospital |
8, Manjeet Nagar,Opp. Akashwani,Jalna Road-431 005
Aurangabad
BIHAR |
91-0240-2335751
91-0240-2359279
unmesh@drkodlikeri.org |
| Dr. Sachin Sharadchandra Hingmire |
Pentagon Research Pvt. Ltd |
C/o Medipoint Hospitals Pvt. Ltd.,,241/1, New D.P. Road,Aundh,-411 007
Pune
MAHARASHTRA |
09324517648
sshingmire@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Central India Cancer Research institute ethics committee |
Approved |
| Central India Medical Research Ethics committee |
Approved |
| GCS/GCRI Ethics committee |
Approved |
| Kodlikeri and CIIGMA Ethics Committee |
Approved |
| Penta-Med Ethics Committee |
Approved |
| Sciences Research & Ethical Review Committee, Batra Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
chemotherapy induced thrombocytopenia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oprelvekin |
50 μg/kg, once daily, by SC injection for 2 cycles |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
.Subjects of either sex, aged > 18 years
.Documented and confirmed non-myelogenous solid tumor or lymphoma on chemotherapy
.Have experienced thrombocytopenia (platelet count of <50,000 cells/ µL) in the cycle immediately prior to their entry into the study.
.Recovered to a platelet count > 1,00,000 cells/µL before initiating the Study Cycle (X+1)
.Bilirubin, SGOT & SGPT of < 2.5 ULN before initiating Study Cycle (X+1)
.Serum Creatinine of < 2 mg/dl before initiating Study Cycle (X+1)
.BUN of < 2 x ULN before initiating Study Cycle (X+1)
.Planned to be undergoing at least two more Cycles of chemotherapy with the same chemotherapy regimen without change in dose.
.ECOG performance status of < 2 at screening.
.Non-pregnant and non-nursing women. If are of child bearing potential must use effective contraceptive measures during the entire study duration.
.Subjects providing written informed consent and willing to undergo all study related procedures.
|
|
| ExclusionCriteria |
| Details |
.Known allergies to E.Coli proteins
.Patient has known hypersensitivity to IL-11 or any component of Oprelvekin.
.Prior treatment with Oprelvekin / IL-11 in previous cycle
.History of rapidly progressive disease
.Received Aspirin, NSAID?s, anti-coagulant drugs (except low dose anti-coagulation to prevent catheter thrombosis) within 7 days prior to initiating Chemotherapy Cycle X+1
.Prior cumulative dose of Doxorubicin >300 mg/m2.
.History of Autoimmune Diseases, Thromboembolic disease, except catheter related thrombosis or coagulation factor deficiencies
.Severe Hypokalemia
.Existing active infection requiring systemic antibiotics at the time of enrolment
.Known HIV or HBsAg positive patients
.Patients with Leukemia, Stem Cell Transplant or Bone Marrow Transplant recipients within 60 days prior to screening
.Patients with history of Atrial Arrhythmias or congestive heart failure or patients with New York Heart Association (NYHA) Class III or IV or LVEF <45%
.History of CNS Involvement or Metastasis
.Any significant medical or surgical condition which in the opinion of investigator would interfere with the study participation.
.Pregnant and lactating women
.Any prior or current involvement of bone marrow by tumor
.Subjects who were previously included or had participated in any other clinical study within 90 days prior to the date of consent.
.Prior surgery or radiotherapy within 4 weeks prior to study entry or anticipated to require radiotherapy during the course of study
.History of prior Pelvic Irradiation
.No other active primary malignancy in last 5 years, other than the one for which chemotherapy is being instituted in the current study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| ?Percentage of patients avoiding platelet transfusion (The criteria for platelet transfusion would be a reduction in platelet count below 20,000 cells/μL at any point of time during the study period) |
Any point of time during the study period) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
?Number of patients avoiding platelet transfusions in each individual study cycle, as compared to pervious cycle.
?Duration of thrombocytopenia, defined by time (median time) to recovery of platelet count to ≥50,000 cells/μL
?The time to recovery of platelet count to ≥1,00,000 cells/μL
|
?The time to recovery of platelet count to ≥1,00,000 cells/μL
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/02/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
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
Modification(s)
|
An open label, multi-centric, single arm, non-randomized, prospective study to assess the efficacy and safety of Recombinant Human Interleukin-11 (Oprelvekin) in prevention and treatment of chemotherapy induced thrombocytopenia in adult cancer patients that will be conducted in Six centers in India, The primary outcome of this study is Percentage of patients avoiding requirement of one or more platelet transfusion. |