| CTRI Number |
CTRI/2012/02/002401 [Registered on: 03/02/2012] Trial Registered Prospectively |
| Last Modified On: |
16/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (a type of cancer) |
|
Scientific Title of Study
|
A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic soft tissue sarcoma. |
| Trial Acronym |
PICASSO III |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPM3001 (Amendment 4: 28 July 2011) |
Protocol Number |
| NCT01168791 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| 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)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt. Ltd.Vatika City Point, 11th floor Sector 25, Mehrauli Gurgaon Road.
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Pvt Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point, 11th floor
Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
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Source of Monetary or Material Support
|
| ZIOPHARM Oncology, Inc.
One First Avenue, Parris Building 34
Boston, MA 02129 USA |
|
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Primary Sponsor
|
| Name |
ZIOPHARM Oncology Inc |
| Address |
One First Avenue, Parris Building 34
Boston, MA 02129 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
01-Dynasty B-Wing (Kanakia Spaces) Andheri-Kurla Road, Andheri East, Mumbai-400059, India |
|
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Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
France
Germany
Guatemala
India
Israel
Italy
Panama
Poland
Romania
Russian Federation
Singapore
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajnish Vasant Nagarkar |
Curie Manavata Cancer Centre |
Department of Medical Oncology, Opposite Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004, Maharashtra, India.
Nashik
MAHARASHTRA |
919823061929
drraj@manavatacancercentre.com |
| Dr Sachin Hingmire |
Deenanath Mangeshkar Hospital & Research Center |
Deenanath Mangeshkar Hospital & Research Center, Oncology room No. 7, Erandawne, Pune - 411004,
Pune
MAHARASHTRA |
919324517648
sshingmire@yahoo.com |
| Dr Shona Nag |
Jehangir Clinical Development Center Pvt. Ltd., Jehangir Hospital, |
Dept.of Medical Oncology, Jehangir Clinical Development Center Pvt. Ltd., Jehangir Hospital, 32 Sassoon Road, Pune 411 001,
Pune
MAHARASHTRA |
919371072441
shona_nag@hotmail.com |
| Dr Anjna Surath |
Krishna Institute of Medical Sciences |
Department of Oncology, 1-8-31/1, Minister Road, Secunderabad – 500003, India.
Hyderabad
ANDHRA PRADESH |
919848625040
anjnasurath@hotmail.com |
| Dr Almel Sachin Vamanrao |
P. D. Hinduja National Hospital & Medical Research Center, |
P. D. Hinduja National Hospital & Medical Research Center, Department of oncology, Room no. 103, Veer Savarkar Marg, Mahim, Mumbai – 400 016, India.
Mumbai
MAHARASHTRA |
912224451515
sachinalmel@gmail.com |
| Dr Sreejith Gopinathan Nair |
Regional Cancer Centre, |
Department of Medical Oncology, 4th Floor, Project room, Regional Cancer Centre, Medical College Campus, PO. BOX 2417, Trivandrum - 695011
Thiruvananthapuram
KERALA |
919447040346
sreejith.sg@gmail.com |
| Dr Mukul Goyal |
SEAROC Cancer Center |
S. K. Soni Hospital, Sec-5, Vidhyadhar Nagar, Sikar Road, Jaipur - 302013
Jaipur
RAJASTHAN |
911412700107
drmukulgoyal@yahoo.in |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee - P D Hinduja National Hospital & Medical Research Centre, Mumbai (PI - Dr Sachin Almel - P. D. Hinduja National Hospital & Medical Research Center) |
Approved |
| Human Ethics Committee, Regional Cancer Centre, Trivandrum (PI - Dr Shreejith Nair, Regional Cancer Centre) |
Not Applicable |
| Institutional Ethics Committee - Krishna Institute of Medical Sciences, Secunderabad (PI - Dr Anjana Surath) |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Center Pune (PI - Dr Sachin Hingmire, Deenanath Mangeshkar Hospital & Research Center) |
Approved |
| Jehangir Clinical Development Centre Institutional Review Board, Pune (PI - Dr Shona Nag, Jehangir Clinical Development Centre Pvt Ltd.) |
Approved |
| Professional Ethics Committee - Manavata Clinical Research Institute, Nashik (PI - Dr Rajnish Nagarkar, Curie Manavata Cancer Centre) |
Approved |
| SEAROC Ethics Committee, Jaipur (PI - Dr Anish Maru, SEAROC Cancer Centre) |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Front-line metastatic soft tissue sarcoma, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug: doxorubicin in combination with palifosfamide-tris |
palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles.
doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles.
|
| Comparator Agent |
Drug: doxorubicin in combination with placebo
|
doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.
placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years and less than 65 years.
2. Documented soft tissue sarcoma
3. Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
4. ECOG Performance Status of 0, 1 or 2
5. Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
6. Male and female patients must agree to use a highly reliable method of birth control during study participation.
7. Able to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Age more than 65 years
2. Specific sarcoma histological subtypes including GIST and Ewings sarcoma.
3. Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
4. Any prior anthracycline use.
5. Known allergy to any of the study drugs or their excipients.
6. Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
7. Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) 50 percent.
8. Documented metastases to brain or meninges.
9. Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
10. Currently pregnant or nursing.
11. Radiotherapy with curative intent within 4 weeks of first dose of study drug. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Progression Free Survival followed by Overall Survival |
Time Frame - Assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months or until progression, then every 12 weeks until then death. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires |
Time Frame - Assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death |
| Safety and Tolerability as evaluated using CTCAE v 4.0 |
Time Frame - 22 weeks |
|
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Target Sample Size
|
Total Sample Size="424"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
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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 is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS). Patients who meet the entry criteria will be randomized equally into 1of 2 arms: either to receive doxorubicin plus palifosfamide-tris or doxorubicin plus placebo. |