Special Drug Use-results Surveillance of Tafinlar/Mekinist

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Tafinlar/Mekinist

Clinical Study ID

NCT06262919
CDRB436I1401
  • Ages 6-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, theirlegally authorized representative must have given written informed consent forcooperation in this surveillance prior to patient enrollment.

  3. Patients who start treatment with the product for BRAF-mutation-positiveadvanced/recurrent solid tumors (excluding colorectal cancer) after the approval ofadditional indications

Exclusion

Exclusion Criteria:

  1. Patients who have received or are receiving a product containing the same ingredientas 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

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Tafinlar/Mekinist
Phase:
Study Start date:
February 09, 2024
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Nagakute-city, Aichi 480-1195
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Nagoya, Aichi 464 8681
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyota, Aichi 470-0343
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Daisen, Akita 014-0027
    Japan

    Site Not Available

  • Novartis Investigative Site

    Funabashi, Chiba 273-8588
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kashiwa, Chiba 277 8577
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kurume city, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukuyama, Hiroshima 721-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo, Hokkaido 065-0033
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amagasaki, Hyogo 660-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Mito, Ibaraki 311-4145
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Morioka, Iwate 020 0066
    Japan

    Completed

  • Novartis Investigative Site

    Kagoshima city, Kagoshima 890 8520
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sagamihara, Kanagawa 252-0375
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Yokohama-city, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kochi city, Kochi 781 8555
    Japan

    Site Not Available

  • Novartis Investigative Site

    Natori, Miyagi 981-1293
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Iida, Nagano 395-8502
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Matsumoto, Nagano 390-8621
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Okayama city, Okayama 701-1192
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Izumisano-city, Osaka 598-8577
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Takatsuki, Osaka 569-8686
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kawagoe, Saitama 350 8550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113 8655
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo ku, Tokyo 104 0045
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Minato-ku, Tokyo 105-8471
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shibuya, Tokyo 150-8308
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo 160 8582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Akita, 010-8543
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kochi, 781 8555
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kyoto, 606 8507
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Saitama, 330 8777
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Wakayama, 641-8510
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Yamagata, 990 9585
    Japan

    Active - Recruiting

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