Clinical trial • Phase II • Oncology

Trametinib for Adjuvant BRAF V600E or V600K mutation-positive melanoma | BRAF V600E mutation-positive unresectable or metastatic solid tumours | BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC) | BRAF V600E mutation-positive low-grade glioma (LGG) | BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC) | BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma

Phase II trial of Trametinib for Adjuvant BRAF V600E or V600K mutation-positive melanoma | BRAF V600E mutation-positive unresectable or metastatic solid t…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Adjuvant BRAF V600E or V600K mutation-positive melanoma | BRAF V600E mutation-positive unresectable or metastatic solid tumours | BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC) | BRAF V600E mutation-positive low-grade glioma (LGG) | BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC) | BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-01-2026
First CTIS Authorization Date
30-04-2026

Trial design

Randomised, open-label, trametinib tablets 2 mg (test product, manufactured by sun pharmaceutical industries limited) versus mekinist® (trametinib) tablets 2 mg (reference, distributed by novartis pharmaceuticals corporation) - single-dose, balanced, randomized, two-treatment, two-period, two-sequence, single-dose crossover bioequivalence design in healthy adult subjects under fasting condition.-controlled, crossover Phase II trial across 1 site in Romania.

Randomised
Yes
Open Label
Yes
Comparator
Trametinib tablets 2 mg (test product, Manufactured by Sun Pharmaceutical Industries Limited) versus MEKINIST® (Trametinib) tablets 2 mg (reference, Distributed by Novartis Pharmaceuticals Corporation) - single-dose, balanced, randomized, two-treatment, two-period, two-sequence, single-dose crossover bioequivalence design in healthy adult subjects under fasting condition.
Crossover
Yes
Target Sample Size
72

Eligibility

Recruits 72 No vulnerable populations selected; participants are healthy adult volunteers; consent/assent handling not specified..

Vulnerable Population
No vulnerable populations selected; participants are healthy adult volunteers; consent/assent handling not specified.

Recruitment

Planned Sample Size
72
Recruitment Window Months
4

Geography

Total Number Of Sites
1
Total Number Of Participants
72

Romania

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
34
Number Of Sites
1
Number Of Participants
72

Sites

Site Name
Terapia S.A.
Department Name
Clinical Pharmacology and Pharmacokinetics
Contact Person Name
Elena Timofte
Contact Person Email
Elena.Timofte@sunpharma.com
Number Of Participants
72

Sponsor

Primary sponsor

Full Name
Sun Pharmaceutical Industries Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
India

Investigational products

Investigational Product Name
Trametinib tablets 2 mg (Manufactured by Sun Pharmaceutical Industries Limited, India)
Active Substance
Trametinib
Modality
Small molecule
Routes Of Administration
Oral (tablets)
Route
oral
Authorisation Status
Investigational product (test formulation)
Starting Dose
2 mg
Dose Levels
Single dose: 2 mg
Frequency
single dose
Maximum Dose
2 mg
Investigational Product Name
MEKINIST® (Trametinib) tablets 2 mg (Distributed by Novartis Pharmaceuticals Corporation)
Active Substance
Trametinib
Modality
Small molecule
Routes Of Administration
Oral (tablets)
Route
oral
Authorisation Status
Marketed (distributed product)
Starting Dose
2 mg
Dose Levels
Single dose: 2 mg
Frequency
single dose
Maximum Dose
2 mg

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