NCT06262919 Special Drug Use-results Surveillance of Tafinlar/Mekinist
| NCT ID | NCT06262919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-02-09 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-02-09 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06262919 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 99 Years, studying BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06262919 currently recruiting?
Yes, NCT06262919 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06262919 trial being conducted?
This trial is being conducted at Nagakute, Japan, Nagoya, Japan, Nagoya, Japan, Nagoya, Japan and 11 additional locations.
Who is sponsoring the NCT06262919 clinical trial?
NCT06262919 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 110 participants.