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Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

ConditionsBladder CancerHistone Deacetylase InhibitorEntinostatChemotherapy
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Entinostat

    Drug

    Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).

  • Chemotherapy

    Drug

    Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Entinostat plus chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate, ORR

ORR refers to the percentage of confirmed cases of complete response (CR) and partial response (PR) according to the RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1.

Time frame
36 months

Secondary outcomes

1

ProgressionFree Survival, PFS

PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).

Time frame
36 months
2

Overall Survival, OS

OS refers to the time from the beginning of treatment to death from any reason.

Time frame
36 months
3

Disease Control Rate, DCR

The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.

Time frame
36 months

Other outcomes

Sponsors and contacts

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov

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