BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid TumorNCT06262919
Special Drug Use-results Surveillance of Tafinlar/Mekinist
An observational study of BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor, run by Novartis Pharmaceuticals at 70 sites in Japan.
Trial summary
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
- What is being tested?
- Tafinlar/Mekinist
- How many people
- 110 participants
- Where
- 70 sitesJapan
- Study dates
- 9 Feb 2024to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who used the product for the treatment of BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) as per the package insert.
Who may be able to join
- Patients who have given written consent to cooperate in this surveillance
- For patients aged < 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment.
- Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications
Who cannot join
- Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance
- Patients with BRAF-mutation-positive malignant melanoma
- Patients with BRAF-mutation-positive non-small cell lung cancer
- Patients with BRAF-mutation-positive hairy cell leukemia
Trial locations and contacts
70 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
70 sites in 1 country
Japan70 sites, 39 recruiting
- Active, not recruiting
Novartis Investigative Site
Akita, 0108543
- Completed
Novartis Investigative Site
Amagasaki, Hyōgo, 660-8511
- Recruiting
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113-8655
- Completed
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113-8655
- Completed
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8603
- Recruiting
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519
- Completed
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519
- Withdrawn
Novartis Investigative Site
Chiba, Chiba, 2608677
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 104-8560
- Completed
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
- Completed
Novartis Investigative Site
Daisen, Akita, 0140027
- Recruiting
Novartis Investigative Site
Fukuoka, Fukuoka, 811-1395
- Recruiting
Novartis Investigative Site
Fukuoka, 8128582
- Recruiting
Novartis Investigative Site
Fukuyama, Hiroshima, 721-8511
- Completed
Novartis Investigative Site
Funabashi, Chiba, 273-8588
- Active, not recruiting
Novartis Investigative Site
Habikino, Osaka, 583-0872
- Recruiting
Novartis Investigative Site
Hiroshima, 7348551
- Active, not recruiting
Novartis Investigative Site
Iida, Nagano, 395-8502
- Completed
Novartis Investigative Site
Izumisano, Osaka, 5988577
- Recruiting
Novartis Investigative Site
Kagoshima, 8908520
- Recruiting
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
- Recruiting
Novartis Investigative Site
Kawagoe, Saitama, 3508550
- Completed
Novartis Investigative Site
Kobe, Hyōgo, 650-0011
- Recruiting
Novartis Investigative Site
Kobe, Hyōgo, 6500047
- Recruiting
Novartis Investigative Site
Kochi, 7818555
- Recruiting
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
- Recruiting
Novartis Investigative Site
Kyoto, Kyoto, 602-8566
- Recruiting
Novartis Investigative Site
Kyoto, 6068507
- Recruiting
Novartis Investigative Site
Matsumoto, Nagano, 3908621
- Completed
Novartis Investigative Site
Matsumoto, Nagano, 3908621
- Recruiting
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
- Completed
Novartis Investigative Site
Minato-ku, Tokyo, 108-8639
- Recruiting
Novartis Investigative Site
Mito, Ibaraki, 311-4145
- Completed
Novartis Investigative Site
Morioka, Iwate, 0200066
- Completed
Novartis Investigative Site
Nagakute, Aichi-ken, 480-1195
- Recruiting
Novartis Investigative Site
Nagoya, Aichi-ken, 453-8511
- Completed
Novartis Investigative Site
Nagoya, Aichi-ken, 453-8511
- Completed
Novartis Investigative Site
Nagoya, Aichi-ken, 4648681
- Completed
Novartis Investigative Site
Natori-shi, Miyagi, 981-1293
- Recruiting
Novartis Investigative Site
Ohtsu, Shiga, 5202192
- Recruiting
Novartis Investigative Site
Okayama, Okayama-ken, 7011192
- Recruiting
Novartis Investigative Site
Okayama, 7008558
- Recruiting
Novartis Investigative Site
Osaka, Osaka, 5340021
- Completed
Novartis Investigative Site
Osaka, Osaka, 5340021
- Completed
Novartis Investigative Site
Osaka, Osaka, 550-0015
- Completed
Novartis Investigative Site
Osaka, 5458586
- Recruiting
Novartis Investigative Site
Sagamihara, Kanagawa, 252-0375
- Recruiting
Novartis Investigative Site
Saitama, Saitama, 330-8777
- Recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 0608543
- Recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 0650033
- Recruiting
Novartis Investigative Site
Sendai, Miyagi, 9808574
- Recruiting
Novartis Investigative Site
Setagaya-ku, Tokyo, 1578535
- Completed
Novartis Investigative Site
Shibuya City, Tokyo, 150-8308
- Completed
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
- Completed
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0023
- Completed
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1628666
- Recruiting
Novartis Investigative Site
Shinjuku-ku, Tokyo, 1608582
- Recruiting
Novartis Investigative Site
Shizuoka, 4208660
- Recruiting
Novartis Investigative Site
Sunto Gun, Shizuoka, 4118777
- Recruiting
Novartis Investigative Site
Takatsuki, Osaka, 5698686
- Completed
Novartis Investigative Site
Toyohashi, Aichi-ken, 441-8570
- Completed
Novartis Investigative Site
Toyota, Aichi-ken, 470-0343
- Completed
Novartis Investigative Site
Wakayama, Wakayama, 641-8510
- Recruiting
Novartis Investigative Site
Wakayama, Wakayama, 641-8510
- Active, not recruiting
Novartis Investigative Site
Yamagata, Yamagata, 990-9585
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 236-0004
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 245-8575
- Recruiting
Novartis Investigative Site
Yoshida-gun, Fukui, 910-1193
- Recruiting
Novartis Investigative Site
Yufu, Oita Prefecture, 8795593
About this study
Official title: Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
Read the detailed description
In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice.
Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set).
Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set)
The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.
- Being tested
- Tafinlar/Mekinist
- Keywords
- Tafinlar, dabrafenib, Mekinist, trametinib, BRAF V600E mutation-positive unresectable advanced, solid tumor, Japan, recurrent
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafinlar/MekinistDrug
Also called Dabrafenib/trametinib
There is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Tafinlar/Mekinist | Patients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert. Receives: Drug: Tafinlar/Mekinist |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation
To evaluate impairment in growth and development in pediatric patients (skeletal and sexual maturation) of dabrafenib and/or trametinib in pediatric patients under 18 years old in the post marketing phase.
Measured: Up to 8 years
[Adult patients] overall response rate (ORR)
The Overall Response Rate (ORR) is defined as the proportion of patients with a best OR of confirmed Complete Response (CR) or Partial Response (PR)
Measured: 1 year
Secondary outcomes (3)
[Pediatric patients] Incidence proportion of ORR
The Overall Response Rate (ORR) is defined as the proportion of patients with a best OR of confirmed Complete Response (CR) or Partial Response (PR)
Measured: 1 year
[Pediatric and adult patients] Incidence proportion of PFS
Progression Free Survival (PFS) is the percentage of participants who did not have a progression event.
Measured: 1 year
[Pediatric patients] Number of patients with changes in height and body weight and sexual maturation
Number of pediatric patients with changes in height and body weight and sexual maturation is going to be collected
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start9 Feb 2024
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid TumorStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262919
- Sponsor's protocol ID
- CDRB436I1401
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
- ClinicalTrials.gov ID
- NCT06262919
- Acronym / sponsor ID
- CDRB436I1401
- Keywords
- Tafinlar, dabrafenib, Mekinist, trametinib, BRAF V600E mutation-positive unresectable advanced, solid tumor, Japan, recurrent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
Detailed description
In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the marketed drugs. Registration of the corresponding patients is to be conducted by the central registered system under current medical practice.
Target number of adult patient is 65 (as the number of patients in the effectiveness analysis set).
Target number of pediatric patient is not determined. Estimated number of enrolled patients is approximately 20 (as the number of patients in the enrolled set)
The observation period for pediatric patients will last after the start of treatment until 8 years (planned, November 2031) after the approval of additional indications, regardless of discontinuation of the product, in order to collect long-term information from as many patients as possible during the reexamination period. The duration of observation for adult patients will be 1 year after the start of treatment with the product.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafinlar/Mekinist | – | Drug: Tafinlar/MekinistPatients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who used the product for the treatment of BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) as per the package insert.
Key inclusion criteria (3 listed)
- Patients who have given written consent to cooperate in this surveillance
- For patients aged < 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment.
- Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications
Key exclusion criteria (4 listed)
- Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance
- Patients with BRAF-mutation-positive malignant melanoma
- Patients with BRAF-mutation-positive non-small cell lung cancer
- Patients with BRAF-mutation-positive hairy cell leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafinlar/MekinistAlso: Dabrafenib/trametinibThere is no treatment allocation. Patients administered Tafinlar/Mekinist by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Tafinlar/Mekinist |
Primary outcome
[Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation
Time frame: Up to 8 years
To evaluate impairment in growth and development in pediatric patients (skeletal and sexual maturation) of dabrafenib and/or trametinib in pediatric patients under 18 years old in the post marketing phase.
[Adult patients] overall response rate (ORR)
Time frame: 1 year
The Overall Response Rate (ORR) is defined as the proportion of patients with a best OR of confirmed Complete Response (CR) or Partial Response (PR)
3 secondary outcomes
[Pediatric patients] Incidence proportion of ORR
Time frame: 1 year
[Pediatric and adult patients] Incidence proportion of PFS
Time frame: 1 year
[Pediatric patients] Number of patients with changes in height and body weight and sexual maturation
Time frame: Up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor, run by Novartis Pharmaceuticals at 70 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+81337978748, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation (time frame: Up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.