← Back to Search

Infigratinib for Bladder Cancer (PROOF302 Trial)

Phase 3

Waitlist Available

Research Sponsored by QED Therapeutics, Inc.

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 the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

Awards & highlights

PROOF302 Trial Summary

This trial is testing a new drug to see if it can help prevent a certain type of cancer from coming back after surgery.

Eligible Conditions

Bladder Cancer
Urothelial Carcinoma

PROOF302 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Centrally Determined Disease-free Survival (DFS)

Secondary outcome measures

Investigator-assessed DFS

Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence

Metastasis-free Survival (MFS)

+3 more

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066

23%

Hypoalbuminaemia

23%

Oedema peripheral

23%

Anaemia

15%

Gamma-glutamyltransferase increased

15%

Nausea

15%

Diarrhoea

15%

Blood creatine increased

15%

Urinary tract infection

15%

Visual field defect

15%

Blood creatine phosphokinase increased

15%

Blood creatinine increased

Intestinal perforation

Cancer pain

Cardiac arrest

Cardiac failure

Femur fracture

Colitis

Gastrointestinal haemorrhage

Aphasia

Pyrexia

Vomiting

Rash maculo-papular

Fatigue

Blood alkaline phosphatase increased

Pain in extremity

Alanine aminotransferase increased

Constipation

Hypertension

100%

80%

60%

40%

20%

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

PROOF302 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Infigratinib 125 mgExperimental Treatment1 Intervention

Participants will be randomly assigned (1:1) to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomly assigned (1:1) to receive oral placebo administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Lead Sponsor

8 Previous Clinical Trials

943 Total Patients Enrolled

Helsinn Healthcare SAIndustry Sponsor

41 Previous Clinical Trials

9,536 Total Patients Enrolled

Corina Andresen, MDStudy DirectorQED Therapeutics, Inc.

2 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Infigratinib's most popular application?

"Infigratinib can treat unresectable, metastatic cholangiocarcinomas in humans that have the fgfr2 protein."

Answered by AI

What do we know about Infigratinib from other research?

"State-of-the-art research suggests that Infigratinib is effective. Out of the 10 ongoing studies, 2 are in Phase 3. The 358 locations conducting trials for Infigratinib are primarily based in Columbus, Ohio."

Answered by AI

Does Infigratinib have a high potential for patient harm?

"Infigratinib was given a safety score of 3. This is because there is already some evidence of efficacy from Phase 3 trials as well as numerous rounds of data that support Infigratinib's safety."

Answered by AI

Across how many states is this clinical trial being conducted?

"Patients can be enrolled at MD Anderson Cancer Center at Cooper in Camden, New jersey, The University of Alabama at Birmingham in Birmingham, Alabama, Rocky Mountain Cancer Center in Colorado Springs, Colorado, or 74 other locations."

Answered by AI

Are we still accepting volunteers for this experiment?

"According to the latest update on clinicaltrials.gov, this study is not looking for new patients at the moment. It was first posted on 2020-03-11 and was updated on 2022-10-17. However, there are many other studies (2816 to be exact) that are still enrolling patients."

Answered by AI

Recent research and studies

fgfr3Journal

Targeting <i>fgfr3</i> Alterations with Adjuvant Infigratinib in Invasive Urothelial Carcinoma: The Phase III PROOF 302 Trial

Pal, Sumanta K, Diederik M Somford, Petros Grivas, Srikala S Sridhar, Shilpa Gupta, Joaquim Bellmunt, Guru Sonpavde, et al.. 2022. “Targeting fgfr3 Alterations with Adjuvant Infigratinib in Invasive Urothelial Carcinoma: The Phase III PROOF 302 Trial”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-1629.

fgfr3Journal

Targeting <i>fgfr3</i> Alterations with Adjuvant Infigratinib in Invasive Urothelial Carcinoma: The Phase III PROOF 302 Trial

clinicaltrials.govStudy

Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

2020. "Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197986.