Evaluation of Epalrestat in Metastatic Triple-negative Br... | NCT03244358

Studies
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

NCT03244358

Sponsor

Sun Yat-sen University

Status

Terminated

Last Update Posted

Jan 29, 2021Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Triple Negative Breast Cancer

Interventions

Epalrestat

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty accruing subjects the study accrual was closed

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Jul 23, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 29, 2021Actual

Description Module

Brief Summary

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

Detailed Description

This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Epalrestat	Experimental	Epalrestat added to standard treatment	Drug: Epalrestat

Name	Type	Description	Arm Group Labels	Other Names
Epalrestat	Drug	Epalrestat 50mg tid added to standard chemotherapy treatment	Epalrestat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse	30 months

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	30 months
Overall Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female ≥ 18 years, ≤70 years.
Minimum life expectancy 16 weeks
Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease
Adequate bone marrow and organ function
Availability of archival tumour sample or fresh biopsy Informed consent
Normal organ function

Exclusion Criteria:

Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment
Last dose of palliative radiotherapy <7 days prior to study treatment
Rapidly progressive visceral disease not suitable for further therapy
Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
Elevated ALP in absence of bone metastasis
Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
Participation in another study with investigational product during last 30 days
Inability or unwillingness to comply with study procedures, including inability to take regular oral medication

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases