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.
A phase 1/2 study of Suba-itraconazole and Tamoxifen in platinum resistant ovarian carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
150 mg BD
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
Kinghorn Cancer Centre, St. Vincent's Hospital
Sydney, New South Wales, Australia
Recommended phase 2 dose of Tamoxifen in combination with Suba-itraconazole
Time frame: 1 years
To determine overall response rate as determined by RECIST V1.1 and GCIG CA125 response criteria
ORR
Time frame: 2 years
To determine the duration of response
DOR
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events via CTCAE v5.0
Safety
Time frame: 2 years
Serum concentration of tamoxifen and derivatives
Cmax
Time frame: 2 years
Serum concentration of tamoxifen and derivatives
AUC
Time frame: 2 years
Tissue concentration of tamoxifen and derivatives
mg/g
Time frame: 2 years
Serum concentration of itraconazole
Cmax
Time frame: 2 years
Serum concentration of itraconazole
AUC
Time frame: 2 years
Tissue concentration of itraconazole
mg/g
Time frame: 2 years
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