drugset / Trial / NCT04483505
Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.
Phase 1
Completed
9 enrolled
CRIS Cancer Foundation
Apices Soluciones S.L. · collabBayer · collabPfizer · collab
NaSingle-groupOpen-labelOther
Summary
This study is an open, multicenter, prospective phase I dose escalation clinical trial followed by an expansion cohort. The aim of this study is to asses the Recommended Phase 2 Dose (R2PD) and the safety profile, among other efficacy, in FGFR1/2/3 positive, hormone receptor-positive breast cancer (HRPBC) patients with metastatic disease after progression to the combination of an aromatase inhibitor plus palbociclib, abemaciclib or ribociclib, according RECIST 1.1 criteria.
Timeline
- Start
- 2020-11-25
- Primary completion
- 2023-04-04
- Completion
- 2023-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Subject | Rogaratinib | Small molecule | 400 mg | Oral |
| Subject | Rogaratinib | Small molecule | 600 mg | Oral |