| CTRI Number |
CTRI/2008/091/000004 [Registered on: 18/02/2008] |
| Last Modified On: |
11/02/2013 |
| Post Graduate Thesis |
No |
| 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 the safety and efficacy of a new compound P276-00 in the treatment of multiple myeloma |
Scientific Title of Study
Modification(s)
|
An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| P276-00/15/07 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sujay Kulkarni |
| Designation |
Senior Clinical Leader,Clinical Development and Medical Affairs |
| Affiliation |
|
| Address |
Piramal Healthcare Limited
9th Floor, R Tech Park, Nirlon Complex, Off Western Express Highway,
Goregaon (E)
Mumbai, Maharashtra 400063
India
off western express highway. Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02230275125 |
| Fax |
02230818703 |
| Email |
sujay.kulkarni@piramal.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alan Hatfield |
| Designation |
Executive Vice President, Clinical Research |
| Affiliation |
|
| Address |
Piramal Healthcare Limited
9th Floor, R-Tech Park, Nirlon Complex, Off Western Express
Highway, Goregaon (East), Mumbai 400 063
India
off western express highway. Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02230275002 |
| Fax |
02230275166 |
| Email |
alan.hatfield@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 |
02230275011 |
| Fax |
|
| Email |
sanjeev.hegde@piramal.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Piramal Life Sciencex,Nirlon Complex, off Western Express Highway, Goregaon (E), Mumb |
|
Primary Sponsor
Modification(s)
|
| Name |
Piramal Life Science |
| Address |
Piramal Life Science
9th Floor, R-Tech Park, Nirlon Complex, Off Western Express
Highway, Goregaon (East), Mumbai 400 063
India |
| 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. Vinod Raina |
Dept Of Medical Oncology, All India Institute Of Medical Sciences(AIIMS)New Delhi |
Dept Of Medical Oncology,All India Institute Of Medical Sciences-
New Delhi
DELHI |
01126593679
01126588408
vinodraina@hotmail.com |
| Dr Chetan Deshmukh |
Dr Chetan Deshmukh, Deenanath Mangeshkar Hospital, Pune |
Dr Chetan Deshmukh, Deenanath Mangeshkar Hospital, Pune
Pune
MAHARASHTRA |
9850811449
drchetandeshmukh@gmail.com |
| Dr S Bondarde |
Dr S Bondarde, Shatabdi Superspeciality Hospital, Nashik |
Mumbai Naka, Nashik-5
Nashik
MAHARASHTRA |
9822012422
shaileshbondarde@yahoo.com |
| Dr. M. B. Agarwal |
Haematology Centre, 2nd Floor, Ghamat Lodge, 804/ADr. Ambedkar Road, Dadar T.T. Mumbai – 400014 |
Haematology Centre, 2nd Floor,Ghamat Lodge, 804/ADr. Ambedkar Road, Dadar T.T.-400014
Mumbai
MAHARASHTRA |
02224142272
02224154827
mbagarwal@hotmail.com |
| Dr. Suresh Advani |
Jaslok Hospital & Research Centre, G. Deshmukh Marg, Mumbai -400 026 |
Jaslok Hospital & Research Centre,G. Deshmukh Marg-400 026
Mumbai
MAHARASHTRA |
02266573333
02223520508
shadvani2000@yahoo.com |
| Dr. Ashis Mukhopadhyay |
Netaji Subhash Chandra Bose Cancer Research Institute,16/A, Park lane, Kolkata – 700016 |
Netaji Subhash Chandra Bose Cancer Research Institute,16/A, Park lane,-700016
Kolkata
WEST BENGAL |
03322291049
03322295628
somashis@vsnl.net |
| Dr. D. C. Doval |
Rajiv Gandhi Cancer Institute & Research Centre |
Sector 5, Rohini,-110085
New Delhi
DELHI |
01127051011
01127051037
rshirali@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Comittee, Netaji Subhash Chandra Bose Cancer Research Institute |
Approved |
| Ethics Committee, Jaslok Hospital & Research Centre |
Approved |
| Ethics Committee, Rajiv Gandhi Cancer Institute & Research Centre |
Approved |
| Independent Ethics Committee, Mumbai |
Approved |
| Institutional ethics committee Deenanath Mangeskar hospital & Research Centre |
Approved |
| Institutional Ethics Committee, All India Institute Of Medical Sciences |
Approved |
| Shatabdi Hospital ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Multiple Myeloma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
P276-00 |
P276-00 injection to be administered daily from day 1 to day 5 per 21 day cycle in 200 ml of 5% dextrose as an intravenous infusion over 30 minutes for total of six cycles or till progressive disease or till unacceptable toxicity. Dose of P276-00 for the first cohort - 50 mg/m2/day, second cohort - 70 mg/m2/day, third cohort 132 mg/m2/day and the fourth and last cohort - 185 mg/m2/day |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria
Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy
Monoclonal protein in the serum of greater than or equal to 1 g/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 mg/ 24 hours, or measurable light chains by free light chain assay of greater than or equal to 10 mg/dL, or measurable plasmacytoma
Age greater than or equal to18 years
ECOG performance status less than or equal to 2
Life expectancygreater than or equal to 3 months
Hemoglobin greater than or equal to8.0 gm/dL
Absolute Neutrophil Count (ANC) greater than or equal to1000 cells/mm3
Platelets countgreater than or equal to 50,000/mm3
SGOT/AST less than 3.0 x institutional upper limits of normal
Serum SGPT/ALT less than 3.0 x institutional upper limits of normal
Serum creatinine less than 2.5mg/dL
Serum total bilirubin less than 1.5 x institutional upper limits of normal
Woman of childbearing potential with a negative serum pregnancy test. In addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised.
Ability to understand and the willingness to sign a written informed consent document.
|
|
| ExclusionCriteria |
| Details |
Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade less than or equal to 1) from adverse effects of such therapy received prior to 4 weeks
Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
History of allergic reactions attributed to compounds of similar chemical composition to P276-00.
Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years.
Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, cardiac ejection fraction 40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Women who are pregnant or nursing
Subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of HIV infection.
Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP).
|
|
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 |
Determination of maximaum tolerated dose of P276-00
Characterization of dose limiting and other toxicities of P276-00
|
end of the study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To determine pharmacokinetics of P276-00
To evaluate clinical response of P276-00
To perform exploratory analysis of serum and molecular markers associated with use of and/or response to P276-00 in MM
|
end of the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
02/02/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/01/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an opel label phase I/II study in patients with relapsed and/or refractory multiple myeloma. Patients will be enrolled in cohorts of 3 each. Initial cohort will receive P276-00 at lowest dose of 50 mg/m2/day for 5 days per 21-day cycle. If the dose is well tolerated in the first cycle, then dose escalation will be performed for the next cohort. There will be no intra-patient dose escalation. Each patient will receive the treatment till objective evidence of progression of disease or till 6 cycles. Each patient will be evaluated for safety and efficacy. Dose limiting toxicities occurring during cycle 1 will be considered for dose escalation and for establishing MTD as described in the protocol. Once MTD is reached, up to ten additional patients may be enrolled to obtain further data on safety and efficacy of P276-00 at the MTD. |