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ACTIVE NOT RECRUITING
NCT05156892
PHASE1

Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer

Sponsor: Anthony Joshua, FRACP

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Trial Investigating the Tolerability, Toxicity and Efficacy of Tamoxifen and SUBA-Itraconazole in Patients With Platinum Resistant Recurrent Epithelial Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2022-09-04

Completion Date

2027-01-01

Last Updated

2025-05-15

Healthy Volunteers

No

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

Locations (1)

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, Australia