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FGFR Inhibitor
Infigratinib for Bladder Cancer ((BLASST)-3 Trial)
Phase 1
Waitlist Available
Led By Guru Sonpavde, MD
Research Sponsored by Guru P. Sonpavde
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 time of first administration of study treatment until 4 weeks after rc up to 3 months
Awards & highlights
(BLASST)-3 Trial Summary
This study is evaluating whether a drug that blocks a protein called FGFR (fibroblast growth factor receptor) prior to surgery is safe and effective in patients with bladder cancer that have mutations in FGFR3 or FGFR2 and who cannot receive
Eligible Conditions
- Bladder Cancer
- Fibroblast Growth Factor Receptors
(BLASST)-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after end of treatment, then every 12-24 weeks up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after end of treatment, then every 12-24 weeks up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
≥ 70% of patients receiving at least 1 dose of study treatment followed by completion of radical cystectomy (Feasibility)
Secondary outcome measures
Pathologic complete response (pCR) at time of RC.
Pathologic response (<ypT2N0) at time of RC.
Progression-free proportion after neoadjuvant infigratinib, prior to RC
+1 moreSide effects data
From 2023 Phase 2 trial • 158 Patients • NCT0215906623%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Blood creatine increased
15%
Visual field defect
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Colitis
8%
Pyrexia
8%
Cancer pain
8%
Femur fracture
8%
Constipation
8%
Rash maculo-papular
8%
Intestinal perforation
8%
Vomiting
8%
Cardiac failure
8%
Fatigue
8%
Alanine aminotransferase increased
8%
Hypertension
8%
Gastrointestinal haemorrhage
8%
Aphasia
8%
Blood alkaline phosphatase increased
8%
Pain in extremity
8%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib
(BLASST)-3 Trial Design
1Treatment groups
Experimental Treatment
Group I: InfigratinibExperimental Treatment1 Intervention
Infigratinib daily dosage per protocol 3-week on/1-week off schedule. 4 weeks will constitute 1 cycle of therapy.
Participants will receive 2 cycles (i.e. 8 weeks) and the treatment will be administered as an outpatient.
After completion of therapy, patients will undergo a CT of the chest, abdomen and pelvis (within 2 weeks of the last dose of therapy) and then proceed to Radical cystectomy 2-4 weeks after the last dose of therapy.
Find a Location
Who is running the clinical trial?
QED Therapeutics, Inc.Industry Sponsor
8 Previous Clinical Trials
982 Total Patients Enrolled
Guru P. SonpavdeLead Sponsor
Guru Sonpavde, MDPrincipal InvestigatorDana-Farber Cancer Institute
6 Previous Clinical Trials
200 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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