← Back to Search

Tyrosine Kinase Inhibitor

Erdafitinib for Bladder Cancer

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

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 from screening up to 6 years 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new treatment for cancer that has spread or can't be removed by surgery, and that has a specific genetic change.

Who is the study for?

This trial is for adults with advanced bladder cancer that can't be removed by surgery or has spread, and who have already tried chemotherapy without success. They should be able to perform daily activities with minimal assistance (ECOG score 0-2) and have normal organ function. Women must not be pregnant and agree to contraception.

What is being tested?

The study tests Erdafitinib's effectiveness in shrinking or eliminating tumors in patients with specific genetic changes in their cancer cells. It also looks at how the body processes the drug when taken with Midazolam or Metformin.

What are the potential side effects?

Erdafitinib may cause high phosphate levels, mouth sores, nail problems, skin rash, tiredness, change in hair color, diarrhea, dry mouth/skin/eyes, loss of appetite, altered taste sensation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening up to 6 years 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening up to 6 years 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 6 years 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib

Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib

+10 more

Secondary study objectives

Main Study: Duration of Response (DoR)

Main Study: Overall Survival

Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)

+3 more

Side effects data

From 2024 Phase 1 trial • 35 Patients • NCT03238196

75%

Diarrhea

75%

Oral mucositis

50%

Hypomagnesemia

50%

Nausea

50%

Dry skin

25%

Aspartate aminotransferase increased

25%

Epistaxis

25%

Dysgeusia

25%

Fatigue

25%

Hyperparathyroidism

25%

Alanine aminotransferase increased

25%

Palmar-plantar erythrodysesthesia

25%

Neutrophil decreased

25%

White blood cell decreased

25%

Flushing

25%

Bullous dermatitis

25%

Dysphasia

25%

Anxiety

25%

Peripheral motor neuropathy

25%

Alkaline phosphatase increased

25%

Arthralgia

25%

Flank pain

25%

Blurred vision

25%

Back pain

25%

Dry mouth

25%

Vomiting

25%

Constipation

25%

Alopecia

25%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

Fulvestrant 500mg, Palbociclib 125mg and Erdafitinib 8mg

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 6mg

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 5mg

Expansion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Erdafitinib (8 milligram)Experimental Treatment3 Interventions

Prior to interim analysis 1 (IA1), there were 2 treatment regimens: Regimen 1 (10 milligram \[mg\] once daily, 7 days on/7 days off); and Regimen 2 (6 mg once daily for 28 days). Following IA1, Regimen 1 is closed for further enrollment and starting dose of Regimen 2 is increased to 8 mg once daily for 28 days on a 28-day cycle (referred to as Regimen 3). Participants who enrolled in DDI substudy will receive pretreatment with single doses of midazolam (Day -2) and metformin (Day -1). Participants enrolled in DDI substudy will receive 8 mg erdafitinib treatment from Day 1 to Day 15, single doses of midazolam 2.5 mg (Day 13) and metformin 1000 mg (Day 14) and erdafitinib treatment will continued until disease progression. Participants who completed the DDI substudy and continue to benefit from erdafitinib treatment, will continue to receive erdafitinib in long-term extension (LTE) phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erdafitinib

2017

Completed Phase 2

~180

Midazolam

2018

Completed Phase 4

~1910