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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05156892




Registration number
NCT05156892
Ethics application status
Date submitted
19/10/2021
Date registered
14/12/2021

Titles & IDs
Public title
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
Scientific 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
Secondary ID [1] 0 0
TICTOC
Universal Trial Number (UTN)
Trial acronym
TICTOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SUBA-itraconazole
Treatment: Drugs - Tamoxifen

Experimental: Dose-escalation/ expansion - SUBA-itraconazole (oral 150mg twice daily) and escalating dose of Tamoxifen (oral once daily) then expansion cohort


Treatment: Drugs: SUBA-itraconazole
150 mg BD

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended phase 2 dose of Tamoxifen in combination with Suba-itraconazole
Timepoint [1] 0 0
1 years
Secondary outcome [1] 0 0
To determine overall response rate as determined by RECIST V1.1 and GCIG CA125 response criteria
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
To determine the duration of response
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Incidence of Treatment-Emergent Adverse Events via CTCAE v5.0
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Serum concentration of tamoxifen and derivatives
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Serum concentration of tamoxifen and derivatives
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Tissue concentration of tamoxifen and derivatives
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Serum concentration of itraconazole
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Serum concentration of itraconazole
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Tissue concentration of itraconazole
Timepoint [9] 0 0
2 years

Eligibility
Key inclusion criteria
1. Histological or cytological-based diagnosis of high grade and low grade epithelial ovarian cancer. Patients with clear cell ovarian cancers are not eligible to participate in this study due to higher risk of thromboemboli which could be increased by Tamoxifen.
2. Platinum resistant ovarian cancer with no more than 4 lines of previous systemic therapy (re-treatment with a previous regimen is only counted as 1 line of therapy).
3. Age > 18 years.
4. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
5. Eastern Cooperative Oncology Group Performance Status of 0 or 1
6. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1, defined by the following:

* Neutrophils (absolute neutrophil count ANC >1.5X10^9/L,)
* Hemoglobin >9 g/dL
* Platelet count >100,000/L
* Serum albumin >3 g/dL
* Total bilirubin 1.5 =the upper limit of normal (ULN) and AST and ALT =2.5 XULN, with the following exception:

* Patients with known Gilbert syndrome who have serum bilirubin =3XULN may be enrolled.
* Patients with documented liver metastasis may have AST and ALT =5XULN
* PTT (or aPTT) and INR =1.5XULN (except for patients receiving anticoagulation therapy)
* Serum creatinine = 1.5XULN or creatinine clearance >50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation: (140 - age) X(weight in kg) X0.85 (if female) 72 X(serum creatinine in mg/dL)
7. Life expectancy of at least 3 months
8. Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Patients without any measurable disease may be enrolled on a case-by-case basis in discussion with study principle investigator
9. At least 4 weeks washout period from previous line of treatment (including hormonal treatment) , 2 weeks from radiotherapy
10. Ability to swallow and retain oral medications (without crushing, dissolving or chewing tablets)
11. Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer as approved by study principle investigator
2. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic or asymptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
3. History of or current evidence of HIV infection, Viral hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV] antibody at screening)
4. Patients with symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if not receiving corticosteroids and/or anticonvulsants for at least 7 days prior to first dose of study treatment, and the disease is asymptomatic and radiographically stable for at least 2 weeks after completion of CNS-directed therapy. Patients with untreated stable or asymptomatic brain metastases may be enrolled on a case-by-case basis in discussion with study principal investigator.
5. Patients with existing or past history of deep venous thromboembolism are excluded, unless stable on anticoagulation.
6. Patients with Khorana score of greater than or equal to 3 (see https://www.mdcalc.com/khorana-risk-score-venousthromboembolism- cancer-patients)
7. Known hypersensitivity or contraindication to any component of the study treatment.
8. Inability to comply with study and follow-up procedures.
9. Patients who have not recovered (= grade 2) from adverse events related to previous treatments, unless approved by study principle investigator
10. Patients unable to swallow orally administered medications and patients with gastrointestinal impairment that could affect the ability to take or absorption of oral medications including sub-acute or complete bowel obstruction.
11. Participants with uncontrolled intercurrent illness
12. Participants not recovered from all toxicities related to prior anticancer therapies to CTCAE grade<1 apart from alopecia
13. Patients with psychiatric illness/social situations that would limit compliance with study requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre, St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Anthony Joshua, FRACP
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Concord Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Prince of Wales Hospital, Sydney
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
St Vincent's Hospital, Sydney
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Joshua, FRACP, MBBS, PhD
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anthony Joshua, FRACP, MBBS, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 293555655
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Plan to share participant data with individuals outside this trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05156892