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FGFR Inhibitor

Infigratinib for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights

Study Summary

This trial is testing a new drug, infigratinib, to see if it can help treat hormone receptor-positive, HER2-negative, FGFR-altered breast cancer when used with tamoxifen.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Dose-limiting Toxicities (DLTs)
Secondary outcome measures
Clinical Benefit Rate
Number of Treatment Emergent Adverse Events (TEAE)
Objective Tumor Response Rate
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: Infigratinib (75mg) + TamoxifenExperimental Treatment5 Interventions
In study part 1 (dose exploration), participants will receive up to infigratinib 75 mg. 75 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
Group II: Cohort 2: Infigratinib (125mg) + TamoxifenExperimental Treatment5 Interventions
In study part 1 (dose exploration), participants will receive up to infigratinib 125 mg. 125 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen
Group III: Cohort 1: Infigratinib (100mg) + TamoxifenExperimental Treatment5 Interventions
In study part 1 (dose exploration), participants will receive up to infigratinib 100 mg. 100 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
2005
Completed Phase 4
~29860
Iopamidol
2017
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Industry Sponsor
8 Previous Clinical Trials
978 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,383 Previous Clinical Trials
17,333,886 Total Patients Enrolled
60 Trials studying Breast Cancer
111,176 Patients Enrolled for Breast Cancer
Jennifer Lee Caswell-JinLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
Jennifer Lee Caswell-Jin 2020. "Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504331.
~1 spots leftby Apr 2025
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