Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.

Eligibility criteria

Qualifiers

Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;

Failure of first-line treatment;

There is at least one measurable lesion according to RECIST 1.1;

Archived tumor tissue samples or tumor biopsies must be provided;

Disqualifiers

Patients who received platinum-based chemotherapy after failure of first-line treatment;

Patients who received platinum-based chemotherapy withnin a 24 month before this trial;

Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);

Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;

Trial design

Treatments tested in this trial

  • Entinostat
  • Chemotherapy

Treatment groups

29 Participants
are divided into 1 treatment group