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Breast NeoplasmsPhase 2IPETNCT01662726

A Study to Assess the Ability of a Novel Endocrine Treatment for Breast Cancer, Irosustat, to Slow Down Cancer Growth

A Phase 2 study testing Irosustat in people with Breast Neoplasms, run by Imperial College London at 1 site in United Kingdom.

Terminated

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

Official record
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Trial summary

This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Irosustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2012to Dec 2014
Phase
Phase 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

  • Written informed consent to participate in the trial
  • 18 years of age or older
  • Histologically confirmed ER +ve breast cancer (Allred ≥ 3)
  • Any HER2 status
  • Tumour measuring ≥ 15mm in longest diameter on ultrasound (US) examination
  • Postmenopausal women as defined by any one of the following criteria:
Show all 12Show fewer
  • Amenorrhoea > 12 months at the time of diagnosis and an intact uterus OR,
  • prior bilateral oophorectomy OR,
  • FSH levels within the postmenopausal range (as per local practice) in women aged < 55years who have undergone hysterectomy OR,
  • FSH levels within the postmenopausal range (as per local practice) in women aged < 55 years who have been on Hormone Replacement Therapy (HRT) within the last 12 months and are therefore not amenorrhoeic
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate bone marrow function defined by Hb ≥ 10 g/dl, WBC ≥ 3.0 x109, PLT ≥ 100 x109/L. Adequate renal function defined by a serum creatinine ≤ 1.5 x ULN. Adequate liver function defined by total bilirubin ≤ 1.5 ULN (patients with Gilbert's syndrome exempted), either ALT or AST ≤ 1.5 ULN and ALP ≤ 1.5 ULN

Who cannot join

  • Locally advanced/inoperable breast cancer
  • Clinical evidence of metastatic disease
  • Diffuse or inflammatory tumours
  • Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ)
  • Evidence of bleeding diathesis and PTT and PT ≤ 1.5 x upper limit of normal
  • Concomitant use (defined as use within 4 weeks prior to entry) of HRT or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens)
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  • Previous use of oestrogen implants at ANY time.
  • Concomitant use of:
  • Rifampicin and other CYP2C and 3A inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and St. John's Wort
  • Systemic carbonic anhydrase inhibitors
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTcf) > 450 ms obtained from 3 electrocardiograms (ECGs)
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
  • Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels
  • Evidence of uncontrolled active infection
  • Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
  • Subjects unable to lie flat or fit into the scanner
  • Patients on occupational monitoring for radiation exposure

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College Healthcare NHS Trust

    London, London, W6 8RF

Other trials in United Kingdom

About this study

Official title: A Phase II, Open Label, Preoperative Study to Assess the Efficacy of the Novel Steroid Sulfatase Inhibitor Irosustat in Postmenopausal Women With Early Oestrogen Receptor Positive Breast Cancer

This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether.

IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. FLT-PET scans will be performed before and following treatment with Irosustat. As cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer.

Blood samples will be taken at regular intervals to assess what the new drug does to the body and the safety and tolerability of Irosustat will be assessed. The study incorporates translation aspects/endpoints which are based on the collection of tumour biopsies before and after treatment with Irosustat although the later biopsy is not mandatory.

Read the detailed description

Objectives

Primary:

To assess changes in [18F] fluorothymidine (FLT) uptake using Positron Emission Tomography (PET) following 2 weeks of Irosustat treatment in patients with early, treatment naïve, oestrogen receptor positive (ER +ve) breast cancer

Secondary:

To assess the:

  1. Pharmacodynamic profile of Irosustat
  2. Safety and tolerability of Irosustat

Study Population: Postmenopausal women with early, treatment naïve, ER +ve breast cancer

Being tested
Irosustat
Medical subject headings
Breast Neoplasms

What participants receive

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

  • IrosustatDrug

    Also called BN83495, STX64, 667-coumate

    Irosustat will be administered once daily in 40mg tablets. Treatment will start the day after the baseline FLT-PET and will be continued for a minimum of 2 weeks until the follow up FLT PET scan. For those patients who have consented to a repeat tumour biopsy, treatment will be extended to the day before the procedure. Study medication should be taken in the morning under fasting conditions with a glass of water, 30 minutes before breakfast.

Study groups in NCT01662726
Study groupRoleWhat they receive
IrosustatExperimentalIrosustat 40mg OD for a minimum of 2 weeks until follow up FLT-PET/CT. For those patients consented to a repeat tumour biopsy, treatment will be extended to that day before the procedure.
Receives: Drug: Irosustat

What is being measured

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

  1. Changes in FLT uptake as assessed by PET following 2 weeks of treatment with Irosustat

    Measured: Patients will have a baseline FLT-PET/CT scan and a follow-up scan after 2 weks of treatment with Irosustat

Secondary outcomes (2)

  1. To characterize the pharmacodynamic profile of Irosustat by measuring peripheral blood steroid hormone levels

    Measured: Blood samples will be drawn from patients on day 1, day 7, day 14 and 28 days post administration of the last dose of Irosustat

  2. To evaluate safety and tolerability of Irosustat by collecting toxicities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03: June 14, 2010)

    Measured: Patients will be assesed at baseline, day 7, day 14 and at 30 days following the last dose of Irosustat. Patients who have consented to an optional post treatment tumour biopsy will attend an extra study visit.

Timeline

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

  1. First posted10 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJul 2014
  4. Study completionDec 2014

Why it stopped: Recruitment challenging: lack of suitable pts; recruiting so soon after diagnosis; competing studies. Funding ended despite extensions to grant.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01662726
Sponsor's protocol ID
C/24/2011
Other IDs
2011-005240-10, X-52-58064-011
Acronym
IPET
Status last verified
Aug 2013
First submitted
7 Aug 2012
Last updated
14 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irosustat in people with Breast Neoplasms, run by Imperial College London at 1 site in United Kingdom.

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 12 inclusion and 19 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 Mar 2016. 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 United Kingdom. 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 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: Recruitment challenging: lack of suitable pts; recruiting so soon after diagnosis; competing studies. Funding ended despite extensions to grant.). 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?

Changes in FLT uptake as assessed by PET following 2 weeks of treatment with Irosustat (time frame: Patients will have a baseline FLT-PET/CT scan and a follow-up scan after 2 weks of treatment with Irosustat). 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 NCT01662726.

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 Mar 2016.

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