CTRI

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CTRI Number

CTRI/2026/03/106003 [Registered on: 12/03/2026] Trial Registered Prospectively

Last Modified On:

10/09/2026

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Randomized, Crossover Trial

Public Title of Study

A study to compares dabrafenib made by Rising Pharma with Tafinlar made by Novartis Pharmaceuticals Corporation in participants who are already taking dabrafenib for cancers with BRAF V600E or V600K mutations along with trametinib under fasting conditions

Scientific Title of Study

An Open label balanced randomized two treatment two period two sequence multiple dose multi center steady state crossover oral bioequivalence study of Dabrafenib Mesylate capsules 150 mg twice daily Rising Pharma Holdings Inc USA with Tafinlar Dabrafenib 75mg 4 capsules of Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 USA along with Trametinib 2 mg for the treatment of patients with BRAFV600E or V600K mutations who are already receiving a stable dose of Dabrafenib mesylate capsules under fasting conditions

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
CT25-007 version 02 19 Dec 2025	Protocol Number
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Suman Avula
Designation	Head – Clinical Operations
Affiliation	Jeevan Scientific Technology Limited
Address	Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Hyderabad TELANGANA 500008 India
Phone	8341117698
Fax
Email	suman.avula@jeevanscientific.com

Details of Contact Person
Scientific Query

Name	Dr Suman Avula
Designation	Head – Clinical Operations
Affiliation	Jeevan Scientific Technology Limited
Address	Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Hyderabad TELANGANA 500008 India
Phone	8341117698
Fax
Email	suman.avula@jeevanscientific.com

Details of Contact Person
Public Query

Name	Dr Suman Avula
Designation	Head – Clinical Operations
Affiliation	Jeevan Scientific Technology Limited
Address	Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Jeevan Scientific Technology Limited Plot No. 1 and 2, Sai Krupa Enclave, Golconda Post, Near Lanco Hills, Hyderabad Hyderabad TELANGANA 500008 India Hyderabad TELANGANA 500008 India
Phone	8341117698
Fax
Email	suman.avula@jeevanscientific.com

Source of Monetary or Material Support

Rising Pharma Holdings, Inc.

Primary Sponsor

Name	Rising Pharma Holdings, Inc.,
Address	Suite 1401A 2 Tower Center Blvd East Brunswick NJ 08816 USA
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
Jeevan Scientific Technology Limited	Plot No 1 and 2 Sai Krupa Enclave Golconda Post Near Lanco Hills Hyderabad 500008
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 26
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Aman Chaudhary	Bharati vidyapeeth medical college hospital & research centre	Ground floor, oncology department,super speciality building,pune-satara road, dhankawadi, pune-411043 Pune MAHARASHTRA	9161096741 draman2104@gmail.com
DrDeepak Agrawal	CKS Hospitals	F 98 A, Road Number 6, Sikar Road, VKI, Jaipur - 302013 Jaipur RAJASTHAN	9414152959 deepak@ckshospitals.com
Dr Kavi Sankar Venkatachalam	Erode Cancer Centre	1/393, velavan nagar, perundurai road, Erode 638012, Tamilnadu, India Erode TAMIL NADU	9944585824 eccmedonco@gmail.com
Dr Nishitha Shetty	Father muller medical college and hospital	Father Muller Road, Kankanadi Mangalore, Karnataka India 575002 Dakshina Kannada KARNATAKA	9167273040 drnishithashetty@gmail.com
Dr Govindaraj Ganesan	Harshmitra oncology Private Limited	101 4 A Mathur Panchayat Road Madhurai Highway Nagamangalam Trichy Tamilnadu India 620012 Tiruchirappalli TAMIL NADU	7373542777 04312680009 govindarajganesan@gmail.com
Dr Lakshmi Priyadarshini K	HCG City Cancer Centre	44-1-1/3 Padavalarevu, Gunadala Vijayawada NTR Andhra Pradesh - 520004 Vizianagaram ANDHRA PRADESH	99660 30988 Priyadarshini006@gmail.com
Dr Raj Nagarkar	HCG Manavata cancer centre	Manavata Health Campus, Mumbai Naka, Nashik-422002, Maharastra, India. Nashik MAHARASHTRA	9823061929 drraj@manavatacancercentre.com
DrAmale Vaibhav Baburao	Horizon Multispeciality hospital	Plot No.1+3, Dhamani Road, sangli, Maharashtra-416416 Sangli MAHARASHTRA	8390913771 vai7444@gmail.com
Dr Jayant Pundlik gawande	Imperial Multispecialty Hospital	GAT No 1193 Pingale Pride Near Radha Swami Ashram Chikhali Pune Maharashtra 411062 India Pune MAHARASHTRA	8412069900 drjayantgawande@gmail.com
Dr Nikhil Mallinath Shirshi	Indrayani Hospital And Cancer Institute	Alandi-Chakan Road Alandi Devachi Pune Maharashtra - 412105 India Pune MAHARASHTRA	7835826155 snikhil15@gmail.com
Dr Kumar Saurabh	Jharkand Cancer centre	Jharkand cancer centre,H B Road, kokar, ranchi, jharkand-834001 Ranchi JHARKHAND	8789474097 ksoncologist@gmail.com
Dr Vipul Doshi	Kamal Medicare cancer and superspeciality hospital	155/4 Gandhi Nagar Road Akkalkot Nakka,Solapur Maharashtra 413005 India Solapur MAHARASHTRA	9773500410 doshivipul26@gmail.com
DrYathish Kumar	Karnataka Cancer Hospital	99 Kanteerava Studio Main Rd Krishnananda Nagar Yeswanthpur Bengaluru Karnataka 560096 Bangalore KARNATAKA	8032943283 dryathish@hotmail.com
DrMadhavi Mohata	KIMS-Kingsway Hospitals	44, Kingsway, Near Kasturchand Park, Nagpur - 440001, Maharashtra, India Nagpur MAHARASHTRA	9421200711 madhavimedonco@gmail.com
Dr Praveen Adusumilli	Kolhapur Cancer Centre Pvt Ltd	R S 238 Opp Mayur Petrol Pump Gokul ShirgaonKolhapur Maharashtra 416234 India Kolhapur MAHARASHTRA	9100755777 praveen.adusumilli@kolhapurcancercentre.com
DrJai SankarP	Lisie Hospital	North Kaloor, Kaloor, Ernakulam, Kerala 682018 Ernakulam KERALA	9567368081 mejaisankar@gmail.com
DrSatish Sonawane	Maccare Superspeciality Hospital	Hotel Nishant Zopadi, opp. Saint Monika D.Ed. College, Savedi, Ahilyanagar, Maharashtra 414003 Ahmadnagar MAHARASHTRA	9730099999 drsatishmaccaretrials@gmail.com
DrTushar Rajendra Mule	Marathwada Cancer Hospital & Research Institute	Plot No. 2, Dnyaneshwar Nagar, In Front of Stadium Garkheda, sut girni, Darga Rd, Chhatrapati Sambhajinagar, Maharashtra 431002 Aurangabad MAHARASHTRA	98204 03558 dr.tusharmchri@gmail.com
Dr Anil Kumar MR	Oncoville Cancer Hospital And Research Centre	No.4, 80 Ft. Road, 7th Block, Nagarbhavi 2nd Stage Bengaluru Urban Bengaluru (Bangalore) Urban Karnataka - 560072 India Bangalore KARNATAKA	97398 08502 dranil.onco@gmail.com
Dr Rohit Kumar	Rajendra Institute of Medical Sciences (RIMS)	Tunkitola, Bariatu, Ranchi, Jharkhand 834009 Ranchi JHARKHAND	9852440549 rohitjhaonco@gmail.com
DrSabeena	Rajiv Gandhi Cancer Institute & Research Centre	Sector 5, Rohini, New Delhi, Delhi, 110085 New Delhi DELHI	9560609753 drsabeenailbs@gmail.com
Dr Alpesh Kumar Jayantilal Kikani	Shashwat cancer centre	2nd floor, CIGIS hospital, near balaji hall,150 feet ring road,rajkot, gujarat, India,360004 Rajkot GUJARAT	9601649096 alpesh.kikani@shashwat.one
Dr Ram Krishan Kajla	SP Medical College and AG of Hospitals	Bikaner Rajasthan 334003 Bikaner RAJASTHAN	1512226300 drrkkajla@gmail.com
Dr Gupta Neha	Swami Harshankarananad ji hospital and research centre	N.8/237 Newada, B.H..U- BLW road, sunderpur varanasi pin-221004 Varanasi UTTAR PRADESH	7839510942 drneha_500@yahoo.com
Dr Vishal Toka	TX Hospitals	8-2-679 8 2 680 A, Road no 12, Banjara Hills, Hyderabad 500034 Hyderabad TELANGANA	9492543446 Vishal.toka@gmail.com
DrNaidu Norman Bethune	Yashoda Hospitals	Hitech City JNTU to Cyber towers road Hyderabad- 500082 Telangana Hyderabad TELANGANA	9966596459 naidunbethune@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 21
Name of Committee	Approval Status
EChorizonmultispecialityhospital	Approved
Ethics Committee SP Medical College	Submittted/Under Review
FatherMullerInstitutionalEthicsCommittee	Submittted/Under Review
IkonEthicsCommitteeForResearchonHumanSubject	Approved
ImperialEthicsCommittee	Approved
Institutional Ethics Committee Erode Cancer Centre	Approved
Institutional Ethics Committee Swami Harshankaranand Ji Hospital and Research Centre	Approved
InstitutionalEthicsCommitteeBharatiVidyapeethDeemedUniversity	Submittted/Under Review
InstitutionalEthicsCommitteeChandanNeuroScience	Approved
InstitutionalEthicsCommitteeHarshamitraoncologyPrivateLimited	Approved
InstitutionalEthicsCommitteeHCGCurieCCCHCGCURIECITYCANCERCENTRE	Approved
InstitutionalEthicsCommitteeHumanGokulLifeCarePrivateLimited	Approved
InstitutionalEthicsCommitteeofOCHandRCOncovilleCancerHospitalAndResearchCentre	Approved
InstitutionalEthicsCommitteeRIMS	Approved
InstitutionalEthicsCommitteeTXhospitals	Approved
InstitutionalEthicsCommitteeyashodaacademyofmedicaleducationandresearch	Approved
KashyapMemorlalEyeHospitalEthicsCommittee	Approved
KCCInstitutionalEthicsCommittee	Approved
KIMS KINGSWAY HOSPITALS ETHICS COMMITTEE	Approved
ManavataClinicalResearchInstituteEthicsCommitteeHCGManavataCancerCentre	Approved
Narsimha Saraswati Medical Foundation	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E078\|\|Other specified disorders of thyroid, (2) ICD-10 Condition: L99\|\|Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, (3) ICD-10 Condition: J984\|\|Other disorders of lung,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dabrafenib Mesylate 150 mg capsules.	Dabrafenib Mesylate capsules 150 mg will be administered twice daily with 12 hours interval between two dosing along with Trametinib 2 mg with 240 ± 2 mL of water at ambient temperature under fasting conditions i.e. at least one hour before, or at least 2 hours after a meal
Comparator Agent	Tafinlar®(Dabrafenib) 75 mg capsules	Tafinlar®(Dabrafenib) Capsules (75mg 2 capsules) will be administered twice daily with 12 hours interval between two dosing along with Trametinib 2 mg with 240 ± 2 mL of water at ambient temperature under fasting conditions i.e. at least one hour before, or at least 2 hours after a meal

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Inclusion criteria: Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study. 1.Men or woman aged equal or more than 18 years. 2.Histologically confirmed diagnosis of adult patients with a BRAFV600E or V600K mutations detection test. 3.Participants who are already receiving a stable dose of Dabrafenib Mesylate capsules will be included in the study. 4.Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. 5.Karnofsky performance status (KPS) equal or more than 70 Percentage. 6.Women of childbearing potential (WOCBP) and men with reproductive potential must agree to use effective contraception during the study and at least two weeks after the last dose. WOCBP must have a negative serum pregnancy test within 14 days prior to randomization. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status equal or less than 1. 8.Life expectancy of greater than at least 3-6 months. 9.Left ventricular ejection fraction same or more than institutional lower limit of normal (LLN) by echocardiogram (ECHO) 10.Patients must not receive any other investigational agents while on study or within four weeks prior to registration. 11.Patients must not have evidence of interstitial lung disease or pneumonitis. 12.Ability to understand and the willingness to sign a written informed consent document. 13.Adequate function of major organs, meeting the following criteria: •Hematologic parameters: WBC equal or more than 4.0 × 10^9per litre ANC equal or more than 1.5 × 10^9per litre PLT equal or more than 100 × 10^9per litre Hb equal or more than 90 gram per litre. •Biochemical parameters: Serum albumin equal or more than 3.0 gram/ desi litre (30 gram per litre) TBIL equal or less 1.5×ULN ALT and AST equal or less than 2.5×ULN BUN and creatinine equal or less than 1.5×ULN or estimated creatinine clearance equal or more than 60 milli litre /minute (by Cockcroft-Gault formula). •Coagulation: INR or PT equal or less than 1.5×ULN for subjects on anticoagulation therapy, PT must be within the therapeutic range defined by the medication.

ExclusionCriteria

Details

Exclusion Criteria: Patient presenting with any of the following will not be included in the study and the reason for exclusion from the study will be documented: 1.Patients with colorectal cancer and wild type BRAF solid tumors will not be enrolled in the study. 2.Any prior use of BRAF inhibitors (BRAFi) MEK inhibitors (MEKi) or ipilimumab in the advanced or metastatic setting. 3.Exclude patients who require dosage modification or with expected changes in concomitant medications (e.g. trametinib) that may potentially affect the pharmacokinetics of Dabrafenib Mesylate during the study. 4.Patient with ocular melanoma are not eligible. 5.Any major surgery extensive radiotherapy chemotherapy with delayed toxicity biologic therapy or immunotherapy within the last 21 days. Chemotherapy given daily or weekly without the potential for delayed toxicity within the last 14 days. 6.Current use of any prohibited medication. 7. Participants taking corticosteroids (equal or more than 10 mg of prednisone or equivalent). Exceptions may be discussed with the overall PI on a case by case basis. 8. Participants with a personal or family history of long QT syndrome. 9. Historical or current evidence of significant hematologic hepatic neurologic psychiatric renal or other diseases that in the opinion of the investigator would put the Patient at risk through study participation or would affect the study analyses if the disease exacerbates during the study. 10. History of another malignancy with the exception of patients who have been disease-free for 3 years or patients with a history of completely resected non-melanoma skin cancer. 11.Any serious and or unstable pre-existing medical psychiatric disorder or other conditions that could interfere with patient safety obtaining informed consent or complying with study procedures. 12.Known Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. 13.History or evidence of cardiovascular risk including any of the following: • History or evidence of current clinically significant uncontrolled arrhythmia with the exception of atrial fibrillation that will be controlled for more than 30 days prior to randomization. •History of (within 6 months prior to randomization) acute coronary syndromes (including myocardial infarction and unstable angina) coronary angioplasty or stenting. •History or evidence of current equal or more than Class II congestive heart failure as defined by New York Heart Association (NYHA). •Significant uncontrolled or active cardiovascular disease specifically including but not restricted to: History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia History of congenital long QT syndrome. Abnormal QTc (equal or more than 450 msec in males and equal or more than 470 msec in females) Ejection fraction equal or less than 50 percentage as assessed by echocardiogram. •History of arterial thrombotic disease specifically including but not restricted to: Myocardial infarction or unstable angina cerebrovascular event (CVA) or transient ischemic attack (TIA) Peripheral vascular disease or claudication. •Uncontrolled hypertension (Diastolic blood pressure more than 100 mmHg Systolic blood pressure more than 150 mmHg). 14.History of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) within 6 months of study entry. Note: Participants enrolled after this window must be on appropriate therapeutic anticoagulation. 15.History of interstitial lung disease or pneumonitis. 16.History of or current evidence or risk of retinal vein occlusion (RVO) or central serious retinopathy (CSR) predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension uncontrolled hypertension uncontrolled diabetes mellitus or history of hyper viscosity or hypercoagulability syndromes) or visible retinal pathology as assessed by ophthalmic exam considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping. •Intraocular pressure more than 21 mm Hg as measured by tonography. 17.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or excipients. 18.Patient who are pregnant and breast feeding 19. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 90 days prior to visit 1. 20.Inability to provide informed consent. 21.Patients with presence of cutaneous squamous cell carcinoma (cuSCC) (including keratoacanthoma) and non-cutaneous malignancies. 22.Patients with presence of hemorrhagic events including major hemorrhagic events and fatal hemorrhages. 23.Patients with left ventricular ejection fraction (LVEF) reduction or left ventricular dysfunction. 24. Patients with presents of rhabdomyolysis renal failure hepatic events hepatic impairment. 25. Patients with presents of Deep vein thrombosis (DVT) or pulmonary embolism (PE). 26.Patients with presence of severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). 27.Participants with impairment of GI function or GI disease that may significantly alter the absorption of Dabrafenib Mesylate in the opinion of the treating investigator (e.g. ulcerative diseases uncontrolled nausea vomiting diarrhea malabsorption syndrome small bowel resection). 28.Patients with change in dose requirements will be excluded from study. 29.Participants who are unable to swallow or retain oral medication. 30. Participants that require co-administration of strong or moderate CYP3A inhibitors or inducers as these medications may alter Dabrafenib Mesylate concentrations. 31.Any other condition that in the opinion of the investigator may compromise the safety compliance of the patient or would preclude the patient from successful completion of the study. 32.Blood loss or whole blood donation within 90 days prior to drug administration. Positive results for drugs of abuse (alcohol benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates) in urine.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Area Under the Plasma Concentration–Time Curve from time 0 to the end of the dosing interval at Steady State Maximum (peak) plasma drug concentration at Steady State	Period I Day 12 Day 13 Day 14 Day 15 Day 16 Period II Day 27 Day 28 Day 29 Day 30 Day 31

Secondary Outcome

Outcome

TimePoints

Minimum (trough) plasma drug concentration at Steady State
Plasma drug concentration at the end of the dosing interval at Steady State
Average plasma drug concentration over the dosing interval at Steady State
Time to reach maximum plasma drug concentration at Steady State
Terminal elimination half-life at Steady State
Peak-to-trough fluctuation in plasma drug concentration at Steady State
Peak-to-trough fluctuation in plasma drug concentration at Steady State

Period I Day 12 Day 13 Day 14 Day 15 Day 16
Period II Day 27 Day 28 Day 29 Day 30 Day 31

Target Sample Size

Total Sample Size="48"
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

N/A

Date of First Enrollment (India)

03/04/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

Rising Pharma Holdings is seeking marketing authorization approval for Dabrafenib Mesylate capsules dose of 150 mg (twice daily) in USFDA for which demonstration of bioequivalence in patient population for the treatment of patients with BRAFV600E or V600K mutations who are already receiving a stable dose of Dabrafenib Mesylate capsules under fasting conditions.