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INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

NCT04781725 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-17

No results posted yet for this study

Summary

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

Conditions

Interventions

DRUG

INT230-6

INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).

OTHER

Saline injection

Standard 0.9 % NaCl Normal Saline

Sponsors & Collaborators

  • Intensity Therapeutics, Inc.

    collaborator INDUSTRY

  • Ontario Institute for Cancer Research

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Angel Arnaout, MD · Ottawa Hospital Research Institute

  • Arif Awan, MD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2022-03-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781725 on ClinicalTrials.gov