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CTRI Number  CTRI/2014/10/005095 [Registered on: 13/10/2014] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and safety of masitinib to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma  
Scientific Title of Study   A prospective multicenter randomized open-label active controlled two-parallel groups phase3 study to compare the efficacy and safety of masitinib at7.5mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage3 or stage4 melanoma carrying a mutation in the juxta membrane domain of c-kit 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2009-017918-69  EudraCT 
AB08026 version 5.0 dated 13 May 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhir Kumar 
Designation  Head of Clinical Operations  
Affiliation  Maya Clinicals Drug Development Pvt. Ltd. 
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills Hyderabad ANDHRA PRADESH 500082 India

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  09866193953  
Fax  040-233003277  
Email  drsudhirkumar@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Kumar 
Designation  Head of Clinical Operations  
Affiliation  Maya Clinicals Drug Development Pvt. Ltd. 
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills Hyderabad ANDHRA PRADESH 500082 India

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  09866193953  
Fax  040-233003277  
Email  drsudhirkumar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jhansi Reddy 
Designation  CEO 
Affiliation  Maya Clinicals Drug Development Pvt. Ltd.  
Address  H-No 6-3-252-1-7-1 Plot- 545 APM Square Erramanzil Opposite IIPM Krishna Oberoi Road Banjara Hills Hyderabad ANDHRA PRADESH 500082 India 500082 India

Hyderabad
ANDHRA PRADESH
500082
India 
Phone  09177001395  
Fax  040-23303277  
Email  jhansi@mayaclinicals.com  
 
Source of Monetary or Material Support  
AB Science 
 
Primary Sponsor  
Name  AB Science 
Address  3 Avenue George V 75008 PARIS FRANCE 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Maya Clinicals Drug Development Pvt Ltd   H.No: 6-3-252/1/7/1, Plot # 545, APM Square, Erramanzil, Opposite IIPM, Krishna Oberoi Road, Banjara Hills Hyderabad-500082, India  
 
Countries of Recruitment     Greece
Austria
Czech Republic
France
Germany
Hungary
India
Italy
Romania
Serbia
Slovakia
Spain
United States of America  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSurender Beniwal  ACHARYA TULSI REGIONAL CANCER TREATMENT AND RESEARCH INSTITUTE  Consultant Oncologist & Hematologist,Department of Oncology, ACHARYA TULSI REGIONAL CANCER TREATMENT AND RESEARCH INSTITUTE, BIKANER
Bikaner
RAJASTHAN 		 9414370484

beniwal.surendra@gmail.com 
DrShibashish Battacharya  Govt Medical College  Department of Oncology,88, College Street, Kolkata 700073 West Bengal, India
Kolkata
WEST BENGAL 		 09051837235
3322123770
shibashishbhattacharya@ymail.com 
DrKayal Smita  Jawaharlal Institute of Postgraduate Medical Education & Research  Department of Oncology,Dhanvantri Nagar, Gorimedu, Puducherry-605 006.
Pondicherry
PONDICHERRY 		 09894328439

kayalsmita@gmail.com 
DrYathish Kumar  Karnataka Cancer Hospital and Research Center  Department of oncology,No:99, Krishnananda Nagar, Jharakabande Kaval, Yeshwanthpur Industrial Suburb, Nandini Layout, Bangalore-560096
Bangalore
KARNATAKA 		 9880462912

dryathish@hotmail.com 
DrSMukesh  Mysore Medical College and Research Institute and Associated Hospitals  Department of Oncology,Room No:22,Irwin Road, Mysore, Karnataka 570021
Mysore
KARNATAKA 		 09886873788
08212520803
dal_muk1@hotmail.com 
DrAnitha Ramesh  Sri Ramachandran Medical Centre  Department of General Medicine(Oncology) No.1 Ramachandra Nagar, Pourur, Chennai-600116
Chennai
TAMIL NADU 		 9840758567

srmcinnovis@gmail.com 
DrKCLakshmaiah  Srinivasam Cancer Care Hospitals India Pvt ltd  Department of Oncology,# 236/1, Vijayashree Layout, Areekere, Bannerghatta Main Road, Bangalore-5600076
Bangalore
KARNATAKA 		 9448055949

kcluck@gmail.com 
DrSonia Parikh  The Gujarat Cancer & Reasearch Institute  3rd Floor, Nr day-care chemptheraphy unit, Room No:07,NCH campus, Asarwa,Ahmedabad-380016
Ahmadabad
GUJARAT 		 9825034353

gcri.clinicaltrials@gmail.com 
DrKBAkila  VGM Hospital  Department of oncology,4th Floor,2100, Trichy Road, Rajendranagar, Coimbatore-641005
Coimbatore
TAMIL NADU 		 09842270651

kbakila@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, S.P.Medical College & A.G. of Hospitals, Rajasthan  Approved 
GCRI/GCS Ethics Committee  Approved 
Institutional Ethics Committee for Human Research Medical College  Submittted/Under Review 
Institutional Ethics Committee, JIPMER,Puduchery  Submittted/Under Review 
Institutional Ethics Committee, Karntaka Cancer Hospital, Bangalore  Submittted/Under Review 
Institutional Ethics Committee, Mysore Medical College & Research Institute  Approved 
Institutional Ethics Committee, SRMC,Chennai  Submittted/Under Review 
Institutional Ethics Committee,V.G.M.Hospital,Coimbatore  Approved 
Srinivasam Cancer Care Hospitals Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  AB1010  inhibitor of tyrosine kinase, AB1010 at 7.5 mg/kg/day, orally. Until disease progression without clinical benefit, limiting toxicity,patient consent withdrawal 
Comparator Agent  Dacarbazine  Patients will receive dacarbazine as an IV bolus at 1,000 mg/m2 once every three weeks according to current best medical practice untill 24 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patient >18 years old, male or female, weighting more than 40 kg or Body Mass Index (BMI)>18 kg/m²
2. Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable
IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma
3. Patient with detectable c-kit JM mutation (mutation in exon 9, 11 or 13) confirmed by DNA or RNA
sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or
melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis
involving the skin surrounding their primary melanoma)
4. Patient with measurable disease according to RECIST
5. Patient with ECOG ≤ 2
6. Patient with life expectancy > 3 months
7. Patient with adequate organ function
- Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
-Haemoglobin ≥ 10 g/dL
- Platelets (PLT) ≥ 75 x 109/L
- AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastases)
- Gamma GT ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases)
- Bilirubin ≤ 1.5 x ULN (≤ 3 x ULN in case of liver metastases)
- Creatine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
- Albuminaemia ≥ 1 x LLN
- Urea ≤ 2x ULN
- Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
8. Man or woman of child bearing potential, must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for three months after the last treatment intake. Female patients of childbearing potential must have a negative result in the pregnancy test at screening and baseline.
9. Patient able and willing to comply with study visits and procedures as per protocol
10. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed
consent is questionable, the designated legal guardian must sign the informed consent.
11. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment. 
 
ExclusionCriteria 
Details  1. Pregnant, or nursing female patient
2. Patient with other malignancies from which the patient has been continuously disease-free for < 3 years,with the exception of melanoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of the breast
3. Patient with active brain metastases are not eligible. Patients with treated brain metastases are eligible if :
(a) presence of 3 brain lesions or less
(b) lesion(s) diameter is ≤ 2 cm
(c) radiation therapy (gamma knife) was completed ≥ 4 weeks prior to baseline
(d) surgery was completed ≥4 weeks prior to baseline
(e) lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy) ≥ 1 month after brain therapy are considered under control at baseline
4. Patient refractory to dacarbazine defined as patient presenting with disease progression within 3 months from the start of a previous dacarbazine therapy.
5. Prior treatment with a tyrosine kinase c-kit inhibitor
6. Patient with cardiac disorders defined by at least one of the following conditions:
- Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation,
resuscitated sudden death)
- Patient with cardiac failure class III or IV of the NYHA classification
- Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
block 2 and 3, sino-atrial block)
- Syncope without known aetiology within 3 months
- Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic
hypertension
7. Patient with clinically uncontrolled infectious diseases including HIV or AIDS-related illness
8. Major surgery or radiation therapy within four weeks of starting the study treatment
9. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
WASH-OUT
10. Previous radiotherapy, chemotherapy and/or previous adjuvant therapy with interferon, vaccines or therapy
with IL-2 or GM-CSF within 4 weeks prior to baseline. Those patients will require a four weeks wash-out
period before baseline. Similarly, any previous treatment with an investigational agent will Require a washout period of four weeks before baseline 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall Progression Free Survival (PFS)  Overall Progression Free Survival (PFS) is defined as the delay between the date of randomization to the date of
documented progression (according to RECIST) or any cause of death during the study 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival (OS),Survival rate,Tumour assessment,Quality of life assessment,Safety profile using the NCI CTCAE v4.02 classification  week 6, 12, 18, 24 and every 12 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="30" 
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)   27/10/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
A prospective, multicenter, randomized, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit.Total target  is of 200 patient world wide and approximately 30 patients from India. Primary endpoint
- Overall Progression Free Survival (PFS) Secondary endpoint - Overall Survival (OS) - Survival rate at week 6, 12, 18, 24 and every 12 weeks - Tumour assessment - PFS rate at week 6, 12, 18, 24 and every 12 weeks
- Overall Time To Progression (TTP) - TTP rate at week 6, 12, 18, 24 and every 12 weeks - Best response rate, Objective response rate (CR + PR) and Disease control rate (CR + PR + SD) - Quality of life assessment at week 6, 12, 18 and 24 and every 12 weeks - ECOG performance status - EORTC QLQ-C30 ï‚· Safety profile using the NCI CTCAE v4.02 classification
 
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