Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Nanjing University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Bladder Cancer; Chemotherapy; Histone Deacetylase Inhibitor; Entinostat

Treatments: Drug: Chemotherapy; Drug: Entinostat

Study type: Interventional

Funder types: Other

Identifiers

NCT07261592

IUNU-UC-108

Details and patient eligibility

About

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• ECOG score of 0-1 an an estimated survival of at least 6 months;
• Adequate organ function;
• Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
• Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.

Exclusion criteria

• 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;
• Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;
• Patients with serious physical or mental illnesses.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Entinostat plus chemotherapy

Experimental group

Description:

The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.

Treatment:

Drug: Entinostat

Drug: Chemotherapy