Trials / Terminated
TerminatedNCT04985604
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
A Phase 2, Subprotocol of DAY101 Monotherapy for Patients With Recurrent, Progressive, or Refractory Solid Tumors With MAPK Pathway Aberrations
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Day One Biopharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.
Conditions
- Melanoma
- Solid Tumor
- CRAF Gene Amplification
- RAF1 Gene Amplification
- BRAF Gene Fusion
- BRAF Fusion
- CRAF Gene Fusion
- CRAF Fusion
- RAF1 Gene Fusion
- RAF1 Fusion
- Thyroid Cancer, Papillary
- Spitzoid Melanoma
- Pilocytic Astrocytoma
- Pilocytic Astrocytoma, Adult
- Non Small Cell Lung Cancer
- Non-Small Cell Adenocarcinoma
- Colorectal Cancer
- Pancreatic Acinar Carcinoma
- Spitzoid Malignant Melanoma
- Bladder Cancer
- Bladder Urothelial Carcinoma
- MAP Kinase Family Gene Mutation
- RAF Mutation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tovorafenib | Tovorafenib tablet for oral use. |
Timeline
- Start date
- 2021-07-15
- Primary completion
- 2024-07-08
- Completion
- 2024-07-08
- First posted
- 2021-08-02
- Last updated
- 2025-10-02
- Results posted
- 2025-10-02
Locations
20 sites across 7 countries: United States, Australia, Belgium, Canada, France, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04985604. Inclusion in this directory is not an endorsement.