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An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer

NCT03505528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-13

No results posted yet for this study

Summary

This phase 1b study will determine the safety and efficacy of combined treatment of Abraxane and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer.

Participants may be eligible to join this study if they are aged 18 years or above and have been diagnosed with metastatic breast cancer or inoperable locally advanced breast cancer.

All participants will receive a combination of intravenous Abraxane and an oral dose of phenelzine sulfate. Abraxane will be administered weekly for the first 3 weeks of a 4-week cycle for 3 consecutive cycles. Phenelzine sulfate will be taken daily for the duration of the 3 cycles. Five patient cohort groups will receive a progressively increasing dose of phenelzine sulfate. Safety and efficacy will be assessed weekly over the 3 cycles of treatment.

Although both drugs have been used in clinical care for more than a decade, they have not been intentionally combined together in a cancer therapy setting. This means that the combined effect of these two drugs has not been documented. This is being addressed in this study.

Conditions

Interventions

DRUG

Nanoparticle albumin-bound paclitaxel

Abraxane is administered intravenous at a constant dose of 100mg/m2

DRUG

Phenelzine Sulfate

Nardil is administered orally from a starting dose of 15mg/d to a maximum of 90mg/d

Sponsors & Collaborators

  • The Canberra Hospital

    collaborator OTHER

  • Southern Medical Day Care Centre

    collaborator UNKNOWN

  • Liverpool Cancer Therapy Centre

    collaborator OTHER_GOV

  • EpiAxis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Desmond Yip, MBBS · ACT Health

  • Laeeq Malik, MBBS · ACT Health

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Drug
Yes

Countries

  • Australia

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 NCT03505528 on ClinicalTrials.gov