NCT04504331

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Jennifer Lee Caswell-Jin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)

Detailed description

Primary Objective: Determine the maximum (no greater than 125 mg) dose of infigratinib used in combination with the FDA-approved dose and schedule of tamoxifen (Cohort 1) in terms of the number of dose-limiting toxicities observed in the first 2 cycles of therapy in subjects with hormone receptor-positive, HER2-negative advanced breast cancer. Secondary Objective: * Estimate the incidence of treatment-emergent adverse events (serious and non-serious). * Estimate the objective tumor response rate (ORR) in subjects with measurable disease. * Estimate the progression-free survival (PFS). * Estimate the durable clinical benefit rate.

Conditions

• Breast Cancer
• HER2-negative Breast Cancer
• ER Positive Breast Cancer
• PR-Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Infigratinib	Oral dose
DRUG	Tamoxifen	Oral Dose
DRUG	Omnipaque 350	IV contrast agent
DRUG	Iopamidol	IV contrast agent
DIAGNOSTIC_TEST	Computed tomography (CT)	Computed tomography (CT) to assess disease state using Iopamidol and/or Omnipaque 350.

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2020-08-07
• Last updated: 2026-02-12
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study