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Ovarian CancerPhase 1TICTOCNCT05156892

Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer

A Phase 1 study testing SUBA-itraconazole and Tamoxifen in people with Ovarian Cancer, run by Anthony Joshua, FRACP at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
SUBA-itraconazole and Tamoxifen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteAustralia
Study dates
4 Sep 2022to 1 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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).
  • Age > 18 years.
  • Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1, defined by the following:
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  • 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)
  • Life expectancy of at least 3 months
  • 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
  • At least 4 weeks washout period from previous line of treatment (including hormonal treatment) , 2 weeks from radiotherapy
  • Ability to swallow and retain oral medications (without crushing, dissolving or chewing tablets)
  • Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments

Who cannot join

  • 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
  • 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.
  • 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)
  • 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.
  • Patients with existing or past history of deep venous thromboembolism are excluded, unless stable on anticoagulation.
  • Patients with Khorana score of greater than or equal to 3 (see https://www.mdcalc.com/khorana-risk-score-venousthromboembolism- cancer-patients)
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  • Known hypersensitivity or contraindication to any component of the study treatment.
  • Inability to comply with study and follow-up procedures.
  • Patients who have not recovered (≤ grade 2) from adverse events related to previous treatments, unless approved by study principle investigator
  • 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.
  • Participants with uncontrolled intercurrent illness
  • Participants not recovered from all toxicities related to prior anticancer therapies to CTCAE grade<1 apart from alopecia
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Kinghorn Cancer Centre, St. Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

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

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.

Read the detailed description

A phase 1/2 study of Suba-itraconazole and Tamoxifen in platinum resistant ovarian carcinoma

Conditions
Ovarian Cancer
Being tested
SUBA-itraconazole, Tamoxifen
Keywords
Ovarian Cancer, Tamoxifen, SUBA-Itraconazole, Platinum resistant
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUBA-itraconazoleDrug

    150 mg BD

  • TamoxifenDrug

    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

Study groups in NCT05156892
Study groupRoleWhat they receive
Dose-escalation/ expansionExperimentalSUBA-itraconazole (oral 150mg twice daily) and escalating dose of Tamoxifen (oral once daily) then expansion cohort
Receives: Drug: SUBA-itraconazole; Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 dose of Tamoxifen in combination with Suba-itraconazole

    Measured: 1 years

Secondary outcomes (9)

  1. To determine overall response rate as determined by RECIST V1.1 and GCIG CA125 response criteria

    ORR

    Measured: 2 years

  2. To determine the duration of response

    DOR

    Measured: 2 years

  3. Incidence of Treatment-Emergent Adverse Events via CTCAE v5.0

    Safety

    Measured: 2 years

  4. Serum concentration of tamoxifen and derivatives

    Cmax

    Measured: 2 years

  5. Serum concentration of tamoxifen and derivatives

    AUC

    Measured: 2 years

  6. Tissue concentration of tamoxifen and derivatives

    mg/g

    Measured: 2 years

  7. Serum concentration of itraconazole

    Cmax

    Measured: 2 years

  8. Serum concentration of itraconazole

    AUC

    Measured: 2 years

  9. Tissue concentration of itraconazole

    mg/g

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start4 Sep 2022
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Dose Escalation (3+3) design with Dose Expansion
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156892
Sponsor's protocol ID
TICTOC
Acronym
TICTOC
Status last verified
May 2025
First submitted
19 Oct 2021
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No Plan to share participant data with individuals outside this trial

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SUBA-itraconazole and Tamoxifen in people with Ovarian Cancer, run by Anthony Joshua, FRACP at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose of Tamoxifen in combination with Suba-itraconazole (time frame: 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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