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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafinlar/Mekinist | Patients with BRAF V600E mutation positive unresectable advanced or recurrent solid tumors treated with dabrafenib and trametinib as per Japanese Package Insert. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafinlar/Mekinist | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| [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. | 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) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| [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) | 1 year |
| [Pediatric and adult patients] Incidence proportion of PFS |
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Inclusion Criteria:
Exclusion Criteria:
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patients who used the product for the treatment of BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) as per the package insert.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +81337978748 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Completed | Nagakute | Aichi-ken | 480-1195 | Japan | |
| Novartis Investigative Site |
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|
Progression Free Survival (PFS) is the percentage of participants who did not have a progression event. |
| 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 | Up to 8 years |
| Recruiting |
| Nagoya |
| Aichi-ken |
| 453-8511 |
| Japan |
| Novartis Investigative Site | Completed | Nagoya | Aichi-ken | 453-8511 | Japan |
| Novartis Investigative Site | Completed | Nagoya | Aichi-ken | 4648681 | Japan |
| Novartis Investigative Site | Completed | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Novartis Investigative Site | Completed | Toyota | Aichi-ken | 470-0343 | Japan |
| Novartis Investigative Site | Completed | Daisen | Akita | 0140027 | Japan |
| Novartis Investigative Site | Withdrawn | Chiba | Chiba | 2608677 | Japan |
| Novartis Investigative Site | Completed | Funabashi | Chiba | 273-8588 | Japan |
| Novartis Investigative Site | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Recruiting | Yoshida-gun | Fukui | 910-1193 | Japan |
| Novartis Investigative Site | Recruiting | Fukuoka | Fukuoka | 811-1395 | Japan |
| Novartis Investigative Site | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Recruiting | Fukuyama | Hiroshima | 721-8511 | Japan |
| Novartis Investigative Site | Recruiting | Sapporo | Hokkaido | 0608543 | Japan |
| Novartis Investigative Site | Recruiting | Sapporo | Hokkaido | 0650033 | Japan |
| Novartis Investigative Site | Completed | Amagasaki | Hyōgo | 660-8511 | Japan |
| Novartis Investigative Site | Completed | Kobe | Hyōgo | 650-0011 | Japan |
| Novartis Investigative Site | Recruiting | Kobe | Hyōgo | 6500047 | Japan |
| Novartis Investigative Site | Recruiting | Mito | Ibaraki | 311-4145 | Japan |
| Novartis Investigative Site | Completed | Morioka | Iwate | 0200066 | Japan |
| Novartis Investigative Site | Recruiting | Sagamihara | Kanagawa | 252-0375 | Japan |
| Novartis Investigative Site | Recruiting | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Recruiting | Yokohama | Kanagawa | 245-8575 | Japan |
| Novartis Investigative Site | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Completed | Natori-shi | Miyagi | 981-1293 | Japan |
| Novartis Investigative Site | Recruiting | Sendai | Miyagi | 9808574 | Japan |
| Novartis Investigative Site | Active, not recruiting | Iida | Nagano | 395-8502 | Japan |
| Novartis Investigative Site | Recruiting | Matsumoto | Nagano | 3908621 | Japan |
| Novartis Investigative Site | Completed | Matsumoto | Nagano | 3908621 | Japan |
| Novartis Investigative Site | Recruiting | Yufu | Oita Prefecture | 8795593 | Japan |
| Novartis Investigative Site | Recruiting | Okayama | Okayama-ken | 7011192 | Japan |
| Novartis Investigative Site | Active, not recruiting | Habikino | Osaka | 583-0872 | Japan |
| Novartis Investigative Site | Completed | Izumisano | Osaka | 5988577 | Japan |
| Novartis Investigative Site | Recruiting | Osaka | Osaka | 5340021 | Japan |
| Novartis Investigative Site | Completed | Osaka | Osaka | 5340021 | Japan |
| Novartis Investigative Site | Completed | Osaka | Osaka | 550-0015 | Japan |
| Novartis Investigative Site | Recruiting | Takatsuki | Osaka | 5698686 | Japan |
| Novartis Investigative Site | Recruiting | Kawagoe | Saitama | 3508550 | Japan |
| Novartis Investigative Site | Recruiting | Saitama | Saitama | 330-8777 | Japan |
| Novartis Investigative Site | Recruiting | Ohtsu | Shiga | 5202192 | Japan |
| Novartis Investigative Site | Recruiting | Sunto Gun | Shizuoka | 4118777 | Japan |
| Novartis Investigative Site | Completed | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Recruiting | Bunkyo Ku | Tokyo | 113-8655 | Japan |
| Novartis Investigative Site | Completed | Bunkyo Ku | Tokyo | 113-8655 | Japan |
| Novartis Investigative Site | Completed | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Novartis Investigative Site | Recruiting | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Novartis Investigative Site | Completed | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Novartis Investigative Site | Recruiting | Chuo Ku | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Completed | Chuo Ku | Tokyo | 1040045 | Japan |
| Novartis Investigative Site | Recruiting | Chuo Ku | Tokyo | 1040045 | Japan |
| Novartis Investigative Site | Recruiting | Minato-ku | Tokyo | 105-8471 | Japan |
| Novartis Investigative Site | Completed | Minato-ku | Tokyo | 108-8639 | Japan |
| Novartis Investigative Site | Recruiting | Setagaya-ku | Tokyo | 1578535 | Japan |
| Novartis Investigative Site | Completed | Shibuya City | Tokyo | 150-8308 | Japan |
| Novartis Investigative Site | Completed | Shinjuku Ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Completed | Shinjuku Ku | Tokyo | 1628666 | Japan |
| Novartis Investigative Site | Recruiting | Shinjuku-ku | Tokyo | 1608582 | Japan |
| Novartis Investigative Site | Completed | Wakayama | Wakayama | 641-8510 | Japan |
| Novartis Investigative Site | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
| Novartis Investigative Site | Active, not recruiting | Yamagata | Yamagata | 990-9585 | Japan |
| Novartis Investigative Site | Active, not recruiting | Akita | 0108543 | Japan |
| Novartis Investigative Site | Recruiting | Fukuoka | 8128582 | Japan |
| Novartis Investigative Site | Recruiting | Hiroshima | 7348551 | Japan |
| Novartis Investigative Site | Recruiting | Kagoshima | 8908520 | Japan |
| Novartis Investigative Site | Recruiting | Kochi | 7818555 | Japan |
| Novartis Investigative Site | Recruiting | Kyoto | 6068507 | Japan |
| Novartis Investigative Site | Recruiting | Okayama | 7008558 | Japan |
| Novartis Investigative Site | Completed | Osaka | 5458586 | Japan |
| Novartis Investigative Site | Recruiting | Shizuoka | 4208660 | Japan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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