| CTRI Number |
CTRI/2009/091/000146 [Registered on: 22/09/2009] |
| Last Modified On: |
11/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
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Study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug, suberoylanilide hydroxamic acid (Vorinostat, MK-0683), in the treatment of advanced malignant pleural mesothelioma.
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Scientific Title of Study
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A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| MK0683-014-04 |
Protocol Number |
| NCT00128102 |
ClinicalTrials.gov |
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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 Monisha Sharma |
| Designation |
Director Clinical Research India |
| Affiliation |
|
| Address |
MSD Pharmaceuticals Pvt Ltd,Vatika Towers,Tower-B,6th Floor,Sector 54,Golf Course Roads
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4647300 |
| Fax |
0124-4375564 |
| Email |
monisha_sharma@merck.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Dr Monisha Sharma |
| Designation |
Director Clinical Research India |
| Affiliation |
|
| Address |
6th Floor, Vatika Towers - B, Golf Course Road
Sector 54,
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
91-124-4647300 |
| Fax |
91-124-4375561 |
| Email |
monisha_sharma@merck.com |
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Source of Monetary or Material Support
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| Merck & Co., Inc., US is the Sponsor for the study |
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Primary Sponsor
Modification(s)
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| Name |
Merck and Co Inc US |
| Address |
Merck Sharp and Dohme ,One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Sharma |
Bombay Hospital and Medical Resarch centre |
1st Floor ,12 Marine Lines -400020
Mumbai
MAHARASHTRA |
09820024364
91 22 26408554
docss@rediffmail.com |
| Dr Rakesh Taran |
CHL Apollo hospital |
Opp. Anoop Nagar, A.B. Road-452008
Indore
MADHYA PRADESH |
91-731-2549090
91-731-2549095
rakeshtaran@yahoo.com |
| Dr GS Bhattacharyya |
Orchid nursing home |
P 17 CIT Road ,Phoolbagan -700054
|
033 65441605
033 40045171
docgs@hotmail.com |
| Dr Rajiv Prasad |
Regional cancer centre |
IGIMS,-800014
Patna
BIHAR |
0612 2295116
0612 2295119
rajiv_rprasad@yahoo.com |
| Dr Kumar Prabhash |
Tata Memorial Hospital |
Dr E Borges road,Parel-400012
Mumbai
MAHARASHTRA |
022-24177214
022-24171734
Kp_prabhash@rediffmail.com |
| Dr Kirti patel |
The Gujarat Cancer & Research Institute |
NCH Campus, Asarwa,-380016
Ahmadabad
GUJARAT |
079-22688419
079-22680662
drkirtimpatel@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
| Bombay Hospital Ethics Committee, Mumbai |
Not Applicable |
| CHL Apollo Hospital ethics committee ,Indore |
Approved |
| Ethics Review Board-Orchid Nursing Home |
Approved |
| GCS/GCRI Ethics committee |
Approved |
| Human Ethics Committee-Tata Memorial Hospital,Mumbai. |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C384||Malignant neoplasm of pleura, Pleural Mesothelioma, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
MK 683 |
Mk 683, 300 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity |
| Comparator Agent |
Placebo |
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity |
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Inclusion Criteria
Modification(s)
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| Age From |
18.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma
Patient must have failed prior chemotherapy that included pemetrexed, if available, with either cisplatin or carboplatin
Patient must have adequate bone marrow, liver and kidney function
Patient must be capable of self-care and out of bed for more than 50% of waking hours
Patient must have ability to swallow pills
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| ExclusionCriteria |
| Details |
Patient has been treated with other investigational agent that has similar properties
Patient has an active infection within 2 weeks of the start of study drug, or had treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug
Patient is pregnant or breast feeding
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Method of Generating Random Sequence
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Method of Concealment
Modification(s)
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Centralized |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Overall survival and safety/toxicity of Vorinostat in this population. Treatment will continue until disease progression or unacceptable toxicity. |
Time Frame: Throughout study |
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Secondary Outcome
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| Outcome |
TimePoints |
| Progression-free survival, Overall objective response rate, dyspnea score on LCSS-Meso scale, and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity |
Time Frame: Throughout study |
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Target Sample Size
Modification(s)
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Total Sample Size="660"
Sample Size from India="1"
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
Modification(s)
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Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/03/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2005 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="5"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Other (Terminated) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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The study was discontinued in India due to slow enrollment.
Please note that only one patient was randomized into the study at GCRI Ahmadabad. The patient took the last medication ( discontinued ) on 14 June 2010 . The last site in India was closed on 9th August 2011 & DCGI was informed of the study close out on 7th September 2011. |