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A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer

ConditionsUrinary Bladder NeoplasmsUrologic NeoplasmsReceptor, Fibroblast Growth Factor, Type 3
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.

For each participant, the study will last up to 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale

Cohort A

Have histologically confirmed LG NMIBC.

Have LG IR NMIBC at time of screening

Disqualifiers

All Participants

Have had a prior positive urine cytology within 6 weeks of first day of treatment.

Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment.

Cohort A

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vepugratinib

    Drug

    Administered orally

Treatment groups

161 Participants
are divided into 2 treatment groups
Group A: Cohort A: VepugratinibExperimental treatment 1 intervention
Group B: Cohort B: VepugratinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with LG IR NMIBC with Complete Response

Complete response rate is defined as negative cystoscopy and negative cytology .

Time frame
Baseline, 2 Years
2

Number of Participants with LG UTUC with Complete Response

Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.

Time frame
Baseline, 2 Years

Secondary outcomes

1

Duration of Response

Time frame
Baseline, 5 Years
2

Time to Recurrence

Time frame
Baseline, 5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: