RecruitingNot Applicable

Special Drug Use-results Surveillance of Tafinlar/Mekinist

Japan110 participantsStarted 2024-02-09

Plain-language 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.

Who can participate

Age range6 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

[Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation

Timeframe: Up to 8 years

[Adult patients] overall response rate (ORR)

Timeframe: 1 year

Trial details

NCT IDNCT06262919

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-12-31

Contact for this trial

Novartis Pharmaceuticals

+81337978748 novartis.email@novartis.com

View on ClinicalTrials.gov More BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor trials