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Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.

NCT04483505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-12-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Fundacion CRIS de Investigación para Vencer el Cáncer

    lead OTHER

Principal Investigators

  • Miguel Ángel Quintela-Fandino · Centro Nacional de Investigaciones Oncológicas

  • Luis Manso, MD · Hospital Universitario 12 de Octubre

  • Ramón Colomer i Bosch · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483505 on ClinicalTrials.gov