NCT04483505

Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.

Rogaratinib, Palbociclib and Fulvestrant in Advanced Hormone Receptor Positive, FGFR1/2/3-positive Breast Cancer: Phase I Clinical Trial Plus an Expansion Cohort

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Fundacion CRIS de Investigación para Vencer el Cáncer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Metastatic
• Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Type	Name	Description
DRUG	Combination, Rogaratinib + palbociclib + fulvestrant	Patients will receive rogaratinib, palbociclib and fulvestrant in cycles of 28 days. Escalation Dose will follow a classic 3+3 schedule.The planned dose-levels are as follows: * Level 1: Rogaratinib 400 mg PO BID + standard fulvestrant 500 mg every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 3 patients). * Level 2: Rogaratinib 600 mg PO BID + fulvestrant 500 mg IM every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 6 patients). Treatment will continue until disease progression.

Timeline

• Start date: 2020-11-25
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2020-07-23
• Last updated: 2023-12-28

Locations

8 sites across 1 country: Spain