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Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer

NCT05156892 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-05-15

No results posted yet for this study

Summary

The study's purpose is to understand the effects of a new treatment (suba-itraconazole and tamoxifen) in epithelial ovarian cancer.

Who is it for? Patients may be eligible to join this study with ovarian cancer resistant to platinum-based chemotherapy agents

Study Details:

Participants will receive different doses of tamoxifen and suba-itraconazole to determine the optimal combination dose.

Participants will be seen by the investigators once a week for the first 3 weeks and then once every 4 weeks. Participant will be reviewed by a clinician and undergo regular blood tests, cardiac monitoring and imaging assessments.

Conditions

Interventions

DRUG

SUBA-itraconazole

150 mg BD

DRUG

Tamoxifen

Dose Escalation: Cohort 1: 20 mg OD Cohort 2: 40 mg OD Cohort 3: 60 mg OD Dose-Expansion: Recommended dose from dose-escalation phase of study

Sponsors & Collaborators

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • Concord Hospital

    collaborator OTHER

  • Prince of Wales Hospital, Sydney

    collaborator OTHER_GOV

  • St Vincent's Hospital, Sydney

    collaborator OTHER

  • Anthony Joshua, FRACP

    lead OTHER

Principal Investigators

  • Anthony Joshua, FRACP, MBBS, PhD · St Vincent's Hospital, Sydney

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-04
Primary Completion
2026-01-01
Completion
2027-01-01

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 NCT05156892 on ClinicalTrials.gov