Alveolar Soft-part SarcomaPhase 2CASPSNCT01337401
A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
A Phase 2 study testing Cediranib in people with Alveolar Soft-part Sarcoma, run by Institute of Cancer Research, United Kingdom at 11 sites in 3 countries.
Trial summary
The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS). The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Alveolar Soft-part Sarcoma
- What is being tested?
- Cediranib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Jul 2011to Jan 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
- Age 16 years and older
- Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
- ECOG Performance Status of 0-1
- Life expectancy of >12 weeks
- Progressive disease as defined by RECIST v1.1 within 6 months prior to randomisation
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- Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by CT (or MRI for brain metastases).
- Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non-enzyme inducing anticonvulsant
- The capacity to understand the patient information sheet and ability to provide written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- Able to swallow and retain oral medication
Who cannot join
- Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L
- Serum bilirubin ≥ 1.5 x ULN (unless Gilbert's syndrome)
- ALT or AST ≥ 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
- Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of ≤ 50mL/min
- Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5.
- History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.
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- Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy.
- Any evidence of severe or uncontrolled co-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection.
- Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome.
- Significant recent haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks).
- Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed.
- Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised).
- Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving the last study treatment.
- History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for symptom control.
- Previous treatment with cediranib.
- Known hypersensitivity to any excipient of cediranib.
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion.
- Other concomitant anti-cancer therapy (including LHRH agonists) except steroids
- Recent history of thrombosis
- Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active bleeding, or those causing uncontrolled seizures.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United Kingdom6 sites
Bristol Haematology and Oncology Centre
Bristol
Royal Marsden Hospital
London
University College London Hospital
London
Christie Hospital
Manchester
Royal Victoria Infirmary/Freeman Hospital
Newcastle upon Tyne
Nottingham University Hospitals
Nottingham
Spain3 sites
Hospital Santa Cruz i Sant Pau
Barcelona
Hospital Puerta de Hierro
Madrid
Hospital Miguel Servet
Zaragoza
Australia2 sites
Princess Alexandra Hospital
Brisbane
Royal Prince Alfred Hospital
Sydney
About this study
Official title: A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS).
The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.
Read the detailed description
Patients aged 16 years and older with a histologically confirmed diagnosis of ASPS will be recruited. Eligible patients will be randomised to receive cediranib (30 mg daily po) or placebo (30 mg daily po) in a 2:1 ratio. At 24 weeks post randomisation, treatment will be unblinded after which time all patients on placebo and those who have not progressed on active treatment will be given cediranib. Treatment will then continue until objective disease progression or death.
- Conditions
- Alveolar Soft-part Sarcoma
- Being tested
- Cediranib, Placebo
- Keywords
- Cediranib, ASPS, Sarcoma
- Medical subject headings
- Sarcoma, Alveolar Soft Part, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CediranibDrug
30mg once daily, oral until disease progression
PlaceboDrug
30mg, once daily, oral until 24 weeks or disease progression if sooner
| Study group | Role | What they receive |
|---|---|---|
| Blinded Cediranib | Experimental | Not described Receives: Drug: Cediranib |
| Blinded Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression if sooner) compared to treatment with placebo.
Measured: 24 Weeks of treatment
Secondary outcomes (4)
Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Measured: 24 Weeks of treatment
Progression-free survival and percentage alive and progression-free at 12 months (APF12)
Measured: 12 months of treatment
Length of Overall survival
Measured: Patients will be followed up every 12 weeks
The safety and tolerability profile of cediranib in patients with ASPS
Measured: Assessments will be made at every study visit (8-12 weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Soft-part SarcomaStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337401
- Sponsor's protocol ID
- ICR-CTSU/2010/10027
- Other IDs
- 2010-021163-33, CRUK/10/021, ISRCTN63733470, ISSRECE0036
- Acronym
- CASPS
- Status last verified
- Jan 2019
- First submitted
- 11 Apr 2011
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Judson I, Morden JP, Kilburn L, Leahy M, Benson C, Bhadri V, Campbell-Hewson Q, Cubedo R, Dangoor A, Fox L, Hennig I, Jarman K, Joubert W, Kernaghan S, Lopez Pousa A, McNeil C, Seddon B, Snowdon C, Tattersall M, Toms C, Martinez Trufero J, Bliss JM. Cediranib in patients with alveolar soft-part sarcoma (CASPS): a double-blind, placebo-controlled, randomised, phase 2 trial. Lancet Oncol. 2019 Jul;20(7):1023-1034. doi: 10.1016/S1470-2045(19)30215-3. Epub 2019 May 31.
PubMed 31160249
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)
- ClinicalTrials.gov ID
- NCT01337401
- Acronym / sponsor ID
- CASPS / ICR-CTSU/2010/10027
- Conditions
- Alveolar Soft-part Sarcoma
- Keywords
- Cediranib, ASPS, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Apr 2011 (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.
The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS).
The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.
Detailed description
Patients aged 16 years and older with a histologically confirmed diagnosis of ASPS will be recruited. Eligible patients will be randomised to receive cediranib (30 mg daily po) or placebo (30 mg daily po) in a 2:1 ratio. At 24 weeks post randomisation, treatment will be unblinded after which time all patients on placebo and those who have not progressed on active treatment will be given cediranib. Treatment will then continue until objective disease progression or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded Cediranib | Experimental | Drug: Cediranib |
| Blinded Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
- Age 16 years and older
- Availability of archived tissue blocks or unstained slides to enable confirmation of t(X;17) translocation
- ECOG Performance Status of 0-1
- Life expectancy of >12 weeks
Key exclusion criteria (20 listed)
- Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ≤1.5 x 109/L or platelet count ≤100 x 109/L
- Serum bilirubin ≥ 1.5 x ULN (unless Gilbert's syndrome)
- ALT or AST ≥ 2.5 x ULN. If liver metastases are present, ALT or AST > 5 x ULN
- Serum creatinine > 1.5 x ULN or a creatinine clearance (calculated or measured) of ≤ 50mL/min
- Greater than +1 proteinuria unless urinary protein < 1.5g in a 24 hr period or protein/creatinine ratio < 1.5.
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 |
|---|---|---|
| Cediranib30mg once daily, oral until disease progression | Drug | Blinded Cediranib |
| Placebo30mg, once daily, oral until 24 weeks or disease progression if sooner | Drug | Blinded Placebo |
Primary outcome
To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression if sooner) compared to treatment with placebo.
Time frame: 24 Weeks of treatment
4 secondary outcomes
Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Time frame: 24 Weeks of treatment
Progression-free survival and percentage alive and progression-free at 12 months (APF12)
Time frame: 12 months of treatment
Length of Overall survival
Time frame: Patients will be followed up every 12 weeks
The safety and tolerability profile of cediranib in patients with ASPS
Time frame: Assessments will be made at every study visit (8-12 weekly)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 31160249Judson I, Morden JP, Kilburn L, Leahy M, Benson C, Bhadri V, Campbell-Hewson Q, Cubedo R, Dangoor A, Fox L, Hennig I, Jarman K, Joubert W, Kernaghan S, Lopez Pousa A, McNeil C, Seddon B, Snowdon C, Tattersall M, Toms C, Martinez Trufero J, Bliss JM. Cediranib in patients with alveolar soft-part sarcoma (CASPS): a double-blind, placebo-controlled, randomised, phase 2 trial. Lancet Oncol. 2019 Jul;20(7):1023-1034. doi: 10.1016/S1470-2045(19)30215-3. Epub 2019 May 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cediranib in people with Alveolar Soft-part Sarcoma, run by Institute of Cancer Research, United Kingdom at 11 sites in 3 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 20 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: status not confirmed, as of the sponsor's last update on 24 Jan 2019. 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, Spain, 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. Some participants in this study may receive a placebo. 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?
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?
To evaluate the efficacy of cediranib in the treatment of ASPS by measuring the percentage change in the sum of target marker lesion diameters from randomisation to week 24 (or progression if sooner) compared to treatment with placebo. (time frame: 24 Weeks of treatment). 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 NCT01337401, 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 24 Jan 2019.