AzTrials
AzTrials

Ovarian CancerPhase 1/2NCT04814875

A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy

A Phase 1/2 study testing ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD) in people with Ovarian Cancer and Fallopian Tube Cancer, run by THERAPIM PTY LTD at 6 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 1b/2a multicenter study, which consists of two parts: Part 1: the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesAustralia
Study dates
1 Sep 2021to 30 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Women ≥ 18 years of age
  • Is not a woman of childbearing potential:
  • Surgically sterile (i.e., had a bilateral tubal ligation, hysterectomy, salpingectomy, or bilateral oophorectomy at least 6 months prior to Day 1 of the study) or;
  • Postmenopausal for at least 1 year prior to Day 1 of the study, and have follicle stimulating hormone levels in the postmenopausal range for the study site.
  • Signed written informed consent
  • Histologically confirmed high grade serous or endometrioid carcinoma of the ovary, fallopian tube, or primary peritoneal cancer
Show all 19Show fewer
  • 1 to 3 prior systemic treatment lines. Prior maintenance therapy with bevacizumab or PARP inhibitors is permitted.
  • Platinum-sensitive carcinoma, defined as disease progression after ≥ 6 months following the most recent platinum-based therapy of the disease
  • Measurable disease on CT/MRI scan according to RECIST 1.1
  • ECOG Performance status 0 to 1
  • Life expectancy of at least 6 months
  • Meet the following laboratory requirements:
  • Hemoglobin (HGB) ≥ 100 × 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelet count ≥ 100 × 109/L
  • aPTT/PT ≤ 1.5 x ULN
  • Total bilirubin level ≤ 1.5 × ULN
  • AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis present)
  • Creatinine Clearance > 60 mL/min, as calculated by Cockcroft-Gault formula, or serum creatinine ≤ 1.5 × ULN.

Who cannot join

  • Have received an anti-cancer/investigational drug within 4 weeks prior to study drug administration
  • Have received a vaccine for COVID-19 within 14 days prior to the first dose of ATX-101 or are scheduled/intend to have a COVID-19 vaccine on Day 1 or during the DLT period (i.e. C1D2 [Day 2] through to C2D2 [Day 30]) of the study
  • Have not recovered from AEs (≥ CTCAE Grade 2 other than alopecia) due to agent(s) administered more than 4 weeks earlier
  • Radiotherapy within 4 weeks prior to study drug administration
  • Major surgery or significant trauma within 28 days (4 weeks) of Screening
  • Anticipated requirement for surgery or initiation of anti-cancer therapy, other than described in this study protocol, during the study period
Show all 16Show fewer
  • Known hypersensitivity to any of the combination partners of ATX-101
  • Any malignancy over the last 5 years, other than ovarian/fallopian tube/primary peritoneal cancer, with exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that is considered cured by excision
  • Cardiac failure NYHA III/IV.
  • LVEF < 50% (ECHO or MUGA must not be older than 12 weeks)
  • QTcF > 470 msec
  • Any organ dysfunction or current acute or chronic disease, other than the study indication, that would significantly increase the expected risk in participants participating in the study, in the judgment of the Investigator
  • Pregnant or breast-feeding women
  • Unwilling or unable to follow protocol requirements
  • A past positive status of HIV and/or positive for HIV at Screening
  • Active Hepatitis B or C. In participants with a history of Hepatitis B or Hepatitis C infection, HBsAg and HCV RNA tests have to be negative.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Peninsula and Southeast Oncology

    Frankston, Victoria, 3199

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

  • St John of God Hospital

    Subiaco, Western Australia, 6008

Other trials in Australia

About this study

Official title: Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

This is a Phase 1b/2a multicenter study, which consists of two parts:

Part 1: the Phase 1b part of the study will investigate the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). ATX-101 will be administered intravenously in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. In the case where 20 mg/m² is not tolerated, the dose can be de-escalated to 15 mg/m².

Read more

Part 2: the Phase 2a part of the study will investigate the efficacy and safety of ACD.

ATX-101 will be administered at the dose defined in Part 1 of the study.

Treatment will continue up to six cycles or until disease progression or unacceptable toxicity, participant withdrawal of consent, non-compliance, lost to follow-up, or withdrawal at the Investigators discretion, whichever occurs first.

Being tested
ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)Drug

    Pegylated liposomal doxorubicin (30 mg/m²) will be administered intravenously on Day 1 of each 28-day cycle; carboplatin (AUC5) will be administered intravenously on Day 1 of each cycle.

    ATX-101 will be administered intravenously on Day 2 of each cycle in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design.

Study groups in NCT04814875
Study groupRoleWhat they receive
Part 1 - ACD (Safety)ExperimentalATX-101 plus carboplatin and pegylated liposomal doxorubicin (ACD)
Receives: Drug: ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)
Part 2 - ACD (Efficacy)ExperimentalATX-101 plus carboplatin and pegylated liposomal doxorubicin (ACD)
Receives: Drug: ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)

What is being measured

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

  1. Part 1: To determine the maximum tolerated dose (MTD) of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin. Measured by incidence of Dose Limiting Toxicity.

    Measured by incidence of Dose Limiting Toxicity (DLT): the MTD is defined as the highest dose level at which ≤ 1/6 of treated participants experience a DLT during a DLT period of 30 days. The RP2D will be either the MTD or the highest tested dose level if MTD is not reached.

    Measured: Assessed from the time of the first administered dose of ATX-101 up to the last treatment in Cycle 2 (i.e. Days 2 to 30).

  2. Part 2: To assess the progression free survival (PFS) of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin. Measured by Tumor assessments.

    Measured by tumor imaging (CT-scan or MRI) in accordance to Response Evaluation Criteria in Solid Tumors (RECIST) every 3 months over a treatment/observation period of 21 months for the individual patient. Tumor images will be compared and changes will be noted over the entire time. PFS means that the sum of diameters of target lesions will not increase by more than 20%, taking as reference the smallest sum measured.

    Measured: Assessed from Day 1 to Week 85

Secondary outcomes (3)

  1. Part 1: To assess the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin.

    This is a composite outcome measure. Measured by Incidence, severity, and duration of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs according to CTCAE v5.

    Measured: Assessed from Day 1 to Week 85

  2. Part 1: To characterize the plasma PK profile of ATX-101 following IV infusion in combination with carboplatin/pegylated liposomal doxorubicin.

    Measured by characterizing the PK profile by estimating the Area under the drug concentration-time curve from time 0 to infinity (AUC0-inf).

    Measured: From pre-dose [within 30 min prior to infusion] until 60 min post infusion

  3. Part 2: To assess the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin.

    This is a composite outcome measure. Measured by Incidence, severity, and duration of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs according to CTCAE v5.

    Measured: Assessed from Day 1 to Week 85

Timeline

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

  1. First posted24 Mar 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Why it stopped: For technical reasons, it was decided by the sponsor to close the ongoing ovarian cancer study, AM ATX101-03, immediately.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04814875
Sponsor's protocol ID
AM ATX101-03
Status last verified
Feb 2024
First submitted
4 Mar 2021
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sogaard CK, Otterlei M. Targeting proliferating cell nuclear antigen (PCNA) for cancer therapy. Adv Pharmacol. 2024;100:209-246. doi: 10.1016/bs.apha.2024.04.002. Epub 2024 May 14.

    PubMed 39034053

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD) in people with Ovarian Cancer and Fallopian Tube Cancer, run by THERAPIM PTY LTD at 6 sites 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 19 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was stopped early (reason given: For technical reasons, it was decided by the sponsor to close the ongoing ovarian cancer study, AM ATX101-03, immediately.). Results are not available in the source record.

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?

Part 1: To determine the maximum tolerated dose (MTD) of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin. Measured by incidence of Dose Limiting Toxicity. (time frame: Assessed from the time of the first administered dose of ATX-101 up to the last treatment in Cycle 2 (i.e. Days 2 to 30).). The study lists 2 primary outcomes in all. 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 NCT04814875, which also lists 1 linked publication.

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 14 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in