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Special Drug Use-results Surveillance of Tafinlar/Mekinist

NCT ID: NCT06262919

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-09

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Keywords

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Tafinlar dabrafenib Mekinist trametinib BRAF V600E mutation-positive unresectable advanced solid tumor Japan recurrent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tafinlar/Mekinist

Patients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert.

Tafinlar/Mekinist

Intervention Type DRUG

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.

Interventions

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Tafinlar/Mekinist

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.

Intervention Type DRUG

Other Intervention Names

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Dabrafenib/trametinib

Eligibility Criteria

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Inclusion Criteria

1. Patients who have given written consent to cooperate in this surveillance
2. 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.
3. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications

Exclusion Criteria

1. 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
2. Patients with BRAF-mutation-positive malignant melanoma
3. Patients with BRAF-mutation-positive non-small cell lung cancer
4. Patients with BRAF-mutation-positive hairy cell leukemia
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagakute, Aichi-ken, Japan

Site Status COMPLETED

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status COMPLETED

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status COMPLETED

Novartis Investigative Site

Toyohashi, Aichi-ken, Japan

Site Status COMPLETED

Novartis Investigative Site

Toyota, Aichi-ken, Japan

Site Status COMPLETED

Novartis Investigative Site

Daisen, Akita, Japan

Site Status COMPLETED

Novartis Investigative Site

Chiba, Chiba, Japan

Site Status RECRUITING

Novartis Investigative Site

Funabashi, Chiba, Japan

Site Status COMPLETED

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Kurume, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuyama, Hiroshima, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Amagasaki, Hyōgo, Japan

Site Status COMPLETED

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status COMPLETED

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status RECRUITING

Novartis Investigative Site

Mito, Ibaraki, Japan

Site Status RECRUITING

Novartis Investigative Site

Morioka, Iwate, Japan

Site Status COMPLETED

Novartis Investigative Site

Kagoshima, Kagoshima-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Novartis Investigative Site

Yokohama, Kanagawa-ku, Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status RECRUITING

Novartis Investigative Site

Natori-shi, Miyagi, Japan

Site Status COMPLETED

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status RECRUITING

Novartis Investigative Site

Iida, Nagano, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Matsumoto, Nagano, Japan

Site Status RECRUITING

Novartis Investigative Site

Matsumoto, Nagano, Japan

Site Status COMPLETED

Novartis Investigative Site

Yufu, Oita Prefecture, Japan

Site Status RECRUITING

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Habikino, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Izumisano, Osaka, Japan

Site Status COMPLETED

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status COMPLETED

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status COMPLETED

Novartis Investigative Site

Takatsuki, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Kawagoe, Saitama, Japan

Site Status RECRUITING

Novartis Investigative Site

Saitama, Saitama, Japan

Site Status RECRUITING

Novartis Investigative Site

Sunto Gun, Shizuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Shimotsuke, Tochigi, Japan

Site Status COMPLETED

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shibuya City, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status COMPLETED

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Wakayama, Wakayama, Japan

Site Status COMPLETED

Novartis Investigative Site

Wakayama, Wakayama, Japan

Site Status RECRUITING

Novartis Investigative Site

Yamagata, Yamagata, Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Akita, , Japan

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Fukuoka, , Japan

Site Status RECRUITING

Novartis Investigative Site

Hiroshima, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kochi, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Okayama, , Japan

Site Status RECRUITING

Novartis Investigative Site

Osaka, , Japan

Site Status COMPLETED

Novartis Investigative Site

Shizuoka, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +81337978748

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CDRB436I1401

Identifier Type: -

Identifier Source: org_study_id