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New drug shows promise for Hard-to-Treat bladder cancer

NCT ID NCT02365597

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 2 trial tests a drug called erdafitinib in 239 people with advanced bladder cancer that has certain FGFR gene changes. The drug aims to shrink tumors by blocking signals that help cancer grow. Researchers are checking how well it works and what side effects occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erdafitinib
What this could lead to
If successful, this could provide a new targeted treatment option for people with advanced bladder cancer that has specific genetic changes.
What could go wrong
This is a mid-stage trial, so the drug may not work for everyone or could have side effects. Results may not apply to all bladder cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

239 people

The number who actually took part.

Started

Apr 2015

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable * Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline * Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1, or 2 * Must have adequate bone marrow, liver, and renal function as described in protocol * Negative pregnancy test (urine or serum beta human chorionic gonadotropin \[b-hCG\]) at Screening for women of child bearing potential who are sexually active * Must have shown disease progression according to RECIST, version 1.1, following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression according to RECIST, version 1.1, within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting. These participants will be referred to as chemo-refractory participants. (Participants who have shown disease progression according to RECIST, version 1.1 following prior treatment with anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible) For DDI substudy * Disease progression following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting Exclusion Criteria: * Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted * Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management * Has a history of or current uncontrolled cardiovascular disease * Females who are pregnant, breast-feeding, or planning to become pregnant within 3 months after the last dose of study drug and males ho plan to father a child while enrolled in this study or within 5 months after the last dose of study drug * Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade 1 neuropathy)

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urothelial cancer

Contacts and locations

Locations

  • Study site

    Sedona, Arizona, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Orange, California, United States

  • Study site

    Sacramento, California, United States

  • Study site

    Stanford, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Washington D.C., District of Columbia, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Iowa City, Iowa, United States

  • Study site

    Louisville, Kentucky, United States

  • Study site

    Minneapolis, Minnesota, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Las Vegas, Nevada, United States

  • Study site

    New York, New York, United States

  • Study site

    Charlotte, North Carolina, United States

  • Study site

    Medford, Oregon, United States

  • Study site

    Tualatin, Oregon, United States

  • Study site

    Hershey, Pennsylvania, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Myrtle Beach, South Carolina, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Dallas, Texas, United States

  • Study site

    Denton, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Hampton, Virginia, United States

  • Study site

    Graz, Austria

  • Study site

    Linz, Austria

  • Study site

    Vienna, Austria

  • Study site

    Aalst, Belgium

  • Study site

    Brussels, Belgium

  • Study site

    Charleroi, Belgium

  • Study site

    Ghent, Belgium

  • Study site

    Wilrijk, Belgium

  • Study site

    Angers, France

  • Study site

    Bordeaux, France

  • Study site

    Caen Cédex 05, France

  • Study site

    Dijon, France

  • Study site

    Lyon, France

  • Study site

    Nice, France

  • Study site

    Nîmes, France

  • Study site

    Paris, France

  • Study site

    Saint-Herblain, France

  • Study site

    Suresnes, France

  • Study site

    Villejuif, France

  • Study site

    Berlin, Germany

  • Study site

    Erlangen, Germany

  • Study site

    Essen, Germany

  • Study site

    Freiburg im Breisgau, Germany

  • Study site

    Göttingen, Germany

  • Study site

    Greifswald, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Hanover, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    München, Germany

  • Study site

    Münster, Germany

  • Study site

    Regensburg, Germany

  • Study site

    Straubing, Germany

  • Study site

    Weiden/Opf, Germany

  • Study site

    Bangalore, India

  • Study site

    Kolkata, India

  • Study site

    Mira Road (East), India

  • Study site

    Nadiād, India

  • Study site

    Beer Yaakov, Israel

  • Study site

    Beersheba, Israel

  • Study site

    Haifa, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Tel Aviv, Israel

  • Study site

    Chisinau, Moldova

  • Study site

    Bucharest, Romania

  • Study site

    Cluj-Napoca, Romania

  • Study site

    Craiova, Romania

  • Study site

    Iași, Romania

  • Study site

    Barnaul, Russia

  • Study site

    Moscow, Russia

  • Study site

    Omsk, Russia

  • Study site

    Pyatigorsk, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Ufa, Russia

  • Study site

    Daejeon, South Korea

  • Study site

    Goyang-si, South Korea

  • Study site

    Incheon, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    Badalona, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Madrid, Spain

  • Study site

    Málaga, Spain

  • Study site

    Pamplona, Spain

  • Study site

    Sabadell, Spain

  • Study site

    Santander, Spain

  • Study site

    Santiago de Compostela, Spain

  • Study site

    Seville, Spain

  • Study site

    Valencia, Spain

  • Study site

    Taichung, Taiwan

  • Study site

    Tainan, Taiwan

  • Study site

    Taipei, Taiwan

  • Study site

    Taoyuan, Taiwan

  • Study site

    Istanbul, Turkey (Türkiye)

  • Study site

    Blackburn, United Kingdom

  • Study site

    Dundee, United Kingdom

  • Study site

    Essex, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Metropolitan Borough of Wirral, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Sutton, United Kingdom

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