Dedifferentiated LiposarcomaPhase 2NCT01913652
Ph II Cabazitaxel DD Liposarcoma
A Phase 2 study testing Cabazitaxel in people with Dedifferentiated Liposarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 11 sites in 4 countries.
Trial summary
Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dedifferentiated Liposarcoma
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Oct 2014to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local diagnosis of dedifferentiated liposarcoma
- Age 18-75 yrs
- WHO performance status 0-1
- Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
- Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
- One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
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- Adequate haematological, renal and hepatic function
- Birth control measures
- Estimated life expectancy > 3 months
- Related adverse events from previous therapies ≤ Grade 1
- Written informed consent
Who cannot join
- More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
- Symptomatic CNS metastases
- Previous encephalopathy of any cause or other significant neurological condition
- Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
- Pregnancy
- inflammation of the urinary bladder (cystitis)
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- Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
- Significant cardiac disease
- Uncontrolled severe illness or medical condition, other than DD liposarcoma
- Hypersensitivity to taxanes or their excipients
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United Kingdom4 sites
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)
Bebington
Western General Hospital
Edinburgh, EH4 2XU
Royal Marsden Hospital - Chelsea, London (613)
London
The Christie NHS Foundation Trust (610)
Manchester
France3 sites
CHU de Dijon - Centre Georges-Francois-Leclerc (229)
Dijon, 21079
Centre Leon Berard (227)
Lyon
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)
Marseille
Belgium2 sites
Universitair Ziekenhuis Antwerpen (117)
Antwerp
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
Brussels
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori (704)
Milan
Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)
Padova
About this study
Official title: Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
- Conditions
- Dedifferentiated Liposarcoma
- Being tested
- Cabazitaxel
- Keywords
- dedifferentiated liposarcoma, cabazitaxel
- Medical subject headings
- Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | INN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle.
Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
Measured: 3 years from first patient in
Secondary outcomes (7)
Time to progression
Measured: 3 years from first patient in
Progression free survival
Measured: 3 years from first patient in
Overall survival
Measured: 3 years from first patient in
Objective tumor response
Objective tumor response as defined by RECIST 1.1
Measured: 3 years from first patient in
Time to onset of response
Time to onset of response will be measured for patients achieving an objective response
Measured: 3 years from first patient in
Duration of response
Duration of response will be measured for patients achieving an objective response
Measured: 3 years from first patient in
Occurence of adverse events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Measured: 3 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dedifferentiated LiposarcomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Larry Hayward, MD, Principal investigator, Western General Hospital, Edinburgh, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913652
- Sponsor's protocol ID
- EORTC-1202
- Other IDs
- 2012-003672-39, cabazL06470
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2013
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma
- ClinicalTrials.gov ID
- NCT01913652
- Acronym / sponsor ID
- EORTC-1202
- Conditions
- Dedifferentiated Liposarcoma
- Keywords
- dedifferentiated liposarcoma, cabazitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Sanofi
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelINN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle. Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Local diagnosis of dedifferentiated liposarcoma
- Age 18-75 yrs
- WHO performance status 0-1
- Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
- Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
Key exclusion criteria (10 listed)
- More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
- Symptomatic CNS metastases
- Previous encephalopathy of any cause or other significant neurological condition
- Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelAlso: Jevtana | Drug | Cabazitaxel |
Primary outcome
Progression free survival (PFS)
Time frame: 3 years from first patient in
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment
7 secondary outcomes
Time to progression
Time frame: 3 years from first patient in
Progression free survival
Time frame: 3 years from first patient in
Overall survival
Time frame: 3 years from first patient in
Objective tumor response
Time frame: 3 years from first patient in
Time to onset of response
Time frame: 3 years from first patient in
Duration of response
Time frame: 3 years from first patient in
Occurence of adverse events
Time frame: 3 years from first patient in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Hayward, MD principal investigator
Western General Hospital, Edinburgh, United Kingdom
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Dedifferentiated Liposarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 11 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, France, Belgium, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 years from first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.