Treatment of Metastatic Cancer in Terminally Diagnosed Pa... | NCT05491928

Studies
Treatment of Metastatic Cancer in Terminally Diagnosed Patients

NCT05491928

Sponsor

Matrix Biomed, Inc.

Status

Available

Last Update Posted

Sep 1, 2022Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Metastatic Cancer

Interventions

Tempol

Countries

United States

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 30, 2022

First Submission Date that Met QC Criteria

Aug 4, 2022

First Posted Date

Aug 8, 2022Actual

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

Aug 31, 2022

Last Update Posted Date

Sep 1, 2022Actual

Description Module

Brief Summary

The objective is to provide terminally diagnosed patients with a last line of treatment while improving overall quality of life. Tempol can be added to any chemotherapy regimen to potentially reduce side effects and overcome chemoresistance.

Detailed Description

The objective is to provide terminally diagnosed patients assigned to palliative care and palliative chemotherapy a last line treatment with Tempol. In vivo studies have shown Tempol to work synergistically with a number of chemotherapy agents increasing treatment response and reducing chemoresistance. Additionally, Tempol has been shown to provide protection to non-cancerous cells allowing for increased chemotherapy dosing by reducing side effects. Tempol inhibits HIF-1/VEGF among others in cancerous cells while upregulating GSH/NrF2 among others in non-cancerous cells.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tempol	Drug	Tempol will be given as an adjunct to chemotherapy.		MBM-0-1 MBM-02

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

metastatic terminally diagnosed cancer

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benji Crane	Contact	6264376506		bjcrane@matrixbiomed.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCHealth University of Colorado Cancer Center - Anschutz Medical Campus	Available	Aurora	Colorado	80045	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15547722	Background	Ravizza R, Cereda E, Monti E, Gariboldi MB. The piperidine nitroxide Tempol potentiates the cytotoxic effects of temozolomide in human glioblastoma cells. Int J Oncol. 2004 Dec;25(6):1817-22.

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms