Trials / Terminated
TerminatedNCT04543188
A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF 07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.
Conditions
- Malignant Melanoma
- Carcinoma, Non-Small-Cell Lung
- Brain Neoplasms, Primary
- Brain Neoplasms
- Malignant Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07284890 | PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle) |
| DRUG | Binimetinib | Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily |
| DRUG | Midazolam | Midazolam will be administered 7 days before start of study drug, on Cycle 1 Day 1, and on Cycle 1 Day 15 |
Timeline
- Start date
- 2021-01-08
- Primary completion
- 2024-03-20
- Completion
- 2024-03-20
- First posted
- 2020-09-10
- Last updated
- 2025-10-23
- Results posted
- 2025-10-23
Locations
45 sites across 3 countries: United States, Canada, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04543188. Inclusion in this directory is not an endorsement.