| CTRI Number |
CTRI/2017/03/008178 [Registered on: 22/03/2017] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
To determine safety,tolerability and activity of K0706 in subjects with chronic myeloid leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
Scientific Title of Study
Modification(s)
|
A Phase 1 study to determine safety, tolerability, pharmacokinetics, and activity of K0706, a novel tyrosine kinase inhibitor (TKI) in subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CLR_15_03, V12 Amd 15, 22 Nov 2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-66455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-66455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sandeep Inamdar |
| Designation |
Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-22-66455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Limited |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Limited |
| Address |
17 B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400093 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Kumar Rathnam |
Meenakshi Mission Hospital and Research Centre |
Ground Floor,Medical Oncology OPD,lake area, Melur Road, Madurai-625107,Tamil Nadu, India
Madurai
TAMIL NADU |
91-452-4263000
91-452-2586353
kkrathnam@gmail.com |
| Dr Tapan Saikia |
Prince Aly Khan Hospital |
Amunabad Building, 4th Floor, Room Number 25, Aga hall,Nesbit Road, Mazgaon,Mumbai-400010 Maharashtra,India
Mumbai
MAHARASHTRA |
91-22-23777949
tapan.saikia@gmail.com |
| Dr Apte Shashikant Janardan |
Sahyadri Speciality Hospital |
Plot No. 30 C, Erandawane, Karve Road, Pune 411 004, Maharashtra, India
Pune
MAHARASHTRA |
91-20-6721-3000
91-9822404983
shashikant.apte@gmail.com |
| Dr Arijit Nag |
Tata Medical Center |
14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata - 700160
Kolkata
WEST BENGAL |
91-9051121161
ARIJIT.NAG@TMCKOLKATA.COM |
| DrNavinKhattry |
Tata Memorial Hospital |
Room No 128, Paymaster shodhika, First floor,ACTREC, Kharghar, Sector 22, Navi Mumbai-410210
Mumbai
MAHARASHTRA |
9102227405000
nkhattry@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutinal Ethics Committee Prince Aly Khan Hospital |
Approved |
| Institutional Ethics committee Meenakshi Mission Hospital and Research Center |
Approved |
| Sahyadri speciality hospital |
Approved |
| Tata Medical Center-Institutional Review Board |
Approved |
| Tata Memorial Centre, Advanced Centre For Treatment, Research and Education in Cancer, Intitutional Ethics Committee (TMC-ACTREC) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic myeloid leukemia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
K0706 capsules |
dose escalation study |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Willing and able to give written, and dated, informed consent (or legally acceptable
representative/impartial witness when applicable) and is available for the entire study
- Willing and able to comply with the scheduled visits
- Male or female aged 18 to 65 years (both inclusive)
- Minimum life expectancy of at least 12 months in the Investigator’s opinion |
|
| ExclusionCriteria |
| Details |
- Any major surgery
- Blood transfusion within 4 weeks of IMP administration
- Inability to swallow oral medication
- Inability to undergo venipuncture and/or tolerate venous access
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum tolerated dose |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC, Tmax |
24 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="304"
Sample Size from India="48"
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 1 |
Date of First Enrollment (India)
Modification(s)
|
25/04/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/06/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Part A: Recruitment is complete.
Part B: Closed to the recruitment of participants.
Part C: Not applicable (Part C of the study is not part of
the India-specific protocol). |