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Bone Giant Cell TumorPhase 2REDUCENCT03620149

Reduced Dose-density of Denosumab for Unresectable GCTB

A Phase 2 study testing Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] in people with Bone Giant Cell Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

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 a multi-center, multi-national, open label, single arm phase 2 study of single-agent denosumab. The objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-term use (> 1 year) of denosumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Giant Cell Tumor
What is being tested?
Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
8 sitesin 4 countries
Study dates
26 Sep 2019to 30 Jul 2020
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven primary or metastatic unresectable GCTB or resectable GCTB but not a candidate for surgery, excluding primary or metastatic GCTB in the jaw.
  • Evidence of active disease at time of registration based on local investigator's assessment (according to RECIST v1.1)
  • Age ≥ 18 years old and skeletally mature (ie, radiographic evidence of at least 1 mature long bone (e.g. humerus with closed growth epiphyseal plate)
  • Patient must have received denosumab before entering this trial:
  • The duration of treatment with full dose denosumab (120 mg SC ) as per current label must be at least 12 months and patient may have received up to 15 months of denosumab.
  • And patient must have received at least 12 doses of denosumab 120 mg before entering into this trial.
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  • ECOG/WHO PS 0-2
  • Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
  • Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides, either from the primary tumor or a metastatic lesion, must be available for histological central review.
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first reduced dose of study treatment.
  • WOCBP should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months after the last treatment cycle. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomized partner
  • Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 5 months after the last study treatment.
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

  • Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
  • Concurrent bisphosphonate treatment and calcitonin
  • Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
  • Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
  • Creatinine clearance < 30 mL/min
  • Hemoglobin < 10.0 g/dL or 6.2 mmol/L
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  • Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
  • Active dental or jaw condition which requires oral surgery, including tooth extraction
  • Non-healed dental/oral surgery
  • Planned invasive dental procedure for the course of the study
  • Known hypersensitivity to the active substance or to any of the excipients (glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20)
  • Treatment with other investigational device or drug 30 days prior to registration
  • Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
  • Unstable systemic disease including active and uncontrolled infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before registration
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Spain4 sites

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08041

  • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

    Barcelona, 08908

  • Vall d'Hebron Institut d'Oncologia

    Barcelona

  • Hospital Universitario San Carlos

    Madrid, 28040

Other trials in Spain

United Kingdom2 sites

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

Italy1 site

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna

Other trials in Italy

Netherlands1 site

  • Leiden University Medical Centre

    Leiden, 2300

Other trials in Netherlands

About this study

Official title: Reduced Dose-density of Denosumab for Maintenance Therapy of Unresectable Giant Cell Tumor of Bone: a Multicenter Phase II Study "REDUCE"

This study is a multi-center, multi-national, open label, single arm phase 2 study of single-agent denosumab.

The objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-term use (> 1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC 12-weekly instead of 4-weekly) will be investigated, starting after 1-year (12-15 months) of denosumab full dose, as per current label. The impact on OsteoNecrosis of the Jaw (ONJ) without compromising disease control will be assessed.

Being tested
Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Keywords
denosumab, Giant cell tumor of bone
Medical subject headings
Giant Cell Tumor of Bone

What participants receive

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

  • Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]Drug

    Also called Xgeva

    Denosumab 120 mg, SC, on day 1 of every 12-week cycle

Study groups in NCT03620149
Study groupRoleWhat they receive
DenosumabExperimentaldenosumab at reduced dose
Receives: Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

What is being measured

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

  1. Progression free survival (PFS)

    according to RECIST 1.1

    Measured: 5.8 years after first patient in

  2. Osteonecrosis of the jaw (ONJ) incidence

    Measured: 5.8 years after first patient in

Secondary outcomes (3)

  1. Overall survival

    Measured: 5.8 years after first patient in

  2. Denosumab treatment duration

    Measured: 5.8 years after first patient in

  3. Occurrence of Adverse Events

    according to CTCAE v5.0

    Measured: 5.8 years after first patient in

Timeline

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

  1. First posted8 Aug 2018
  2. Study start26 Sep 2019
  3. Primary completion30 Jul 2020
  4. Study completion30 Jul 2020

Why it stopped: Poor accrual

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620149
Sponsor's protocol ID
EORTC 1762-STBSG
Other IDs
2018-002096-17, 20177203, 2018
Acronym
REDUCE
Status last verified
Jan 2021
First submitted
3 Aug 2018
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] in people with Bone Giant Cell Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

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 15 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain, United Kingdom, Italy, Netherlands. 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: Poor accrual). 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?

Progression free survival (PFS) (time frame: 5.8 years after first patient in). 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 NCT03620149.

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 6 Jan 2021.

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