- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01337401
A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS) (CASPS)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Brisbane, Australien
- Princess Alexandra Hospital
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Sydney, Australien
- Royal Prince Alfred Hospital
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Bristol, Det Forenede Kongerige
- Bristol Haematology and Oncology centre
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London, Det Forenede Kongerige
- University College London Hospital
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London, Det Forenede Kongerige
- Royal Marsden Hospital
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Manchester, Det Forenede Kongerige
- Christie Hospital
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Newcastle-Upon-Tyne, Det Forenede Kongerige
- Royal Victoria Infirmary/Freeman Hospital
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Nottingham, Det Forenede Kongerige
- Nottingham University Hospitals
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Barcelona, Spanien
- Hospital Santa Cruz i Sant Pau
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Madrid, Spanien
- Hospital Puerta de Hierro
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Zaragoza, Spanien
- Hospital Miguel Servet
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Blinded Cediranib
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30mg once daily, oral until disease progression
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Placebo komparator: Blinded Placebo
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30mg, once daily, oral until 24 weeks or disease progression if sooner
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: 24 Weeks of treatment
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24 Weeks of treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Response rate at week 24, best response using RECISTv1.1 and best reduction (%) in tumour size
Tidsramme: 24 Weeks of treatment
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24 Weeks of treatment
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Progression-free survival and percentage alive and progression-free at 12 months (APF12)
Tidsramme: 12 months of treatment
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12 months of treatment
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Length of Overall survival
Tidsramme: Patients will be followed up every 12 weeks
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Patients will be followed up every 12 weeks
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The safety and tolerability profile of cediranib in patients with ASPS
Tidsramme: Assessments will be made at every study visit (8-12 weekly)
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Assessments will be made at every study visit (8-12 weekly)
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICR-CTSU/2010/10027
- 2010-021163-33 (EudraCT nummer)
- CRUK/10/021 (Andet bevillings-/finansieringsnummer: Cancer Research UK)
- ISRCTN63733470 (Registry Identifier: Randomised controlled Trials)
- ISSRECE0036 (Andet bevillings-/finansieringsnummer: AstraZeneca)
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Kliniske forsøg med Alveolar Soft-part Sarcoma
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Novartis PharmaceuticalsAktiv, ikke rekrutterendeAvancerede solide tumorer | Tredobbelt negativ brystkræft | Chordoma og Alveolar Soft Part SarkomForenede Stater, Taiwan, Spanien, Canada, Singapore, Italien, Japan, Israel, Frankrig
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeBlødt vævssarkom | Nyrecellekarcinom | Hepatocellulært karcinom | Osteosarkom | Ewing Sarkom | Tilbagevendende nyrecellekarcinom | Ildfast malignt fast neoplasma | Rhabdomyosarkom | Tilbagevendende Ewing-sarkom | Tilbagevendende hepatoblastom | Tilbagevendende malignt fast neoplasma | Tilbagevendende osteosarkom | Tilbagevendende... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetRhabdomyosarkom | Tilbagevendende osteosarkom | Tilbagevendende rhabdomyosarkom i barndommen | Tidligere behandlet Childhood Rhabdomyosarcoma | Tilbagevendende bløddelssarkom i barndommen | Tilbagevendende Ewing-sarkom/perifer primitiv neuroektodermal tumor | Angiosarkom i barndommen | Epiteloid sarkom... og andre forholdForenede Stater, Canada
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Eastern Cooperative Oncology GroupRekrutteringMelanom | Brystkræft, NOS | CNS Primær Tumor, NOS | Livmoderhalskræft, NOS | Kolorektal cancer, NOS | Leukæmi, NOS | Lymfom, NOS | Diverse Neoplasma, NOS | Non-Rhabdomyosarcoma Soft Tissue Sarcoma, NOS | Testikulær ikke-seminomatøs kimcelletumor, NOS | Kræft i skjoldbruskkirtlen, NOS | Knoglekræft, NOSForenede Stater
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OHSU Knight Cancer InstituteNovartis Pharmaceuticals; Oregon Health and Science UniversityAfsluttetSarkom | Tilbagevendende bløddelssarkom hos voksne | Rhabdomyosarkom hos voksne | Adult Alveolar Soft Part Sarkom | Angiosarkom hos voksne | Voksen desmoplastisk lille rundcellet tumor | Voksen epithelioid hæmangioendotheliom | Voksen epiteloid sarkom | Voksen ekstraskeletalt myxoid chondrosarkom | Voksen... og andre forholdForenede Stater
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Dana-Farber Cancer InstituteAfsluttetSarkom | Blødt vævssarkom | Klarcellet nyrecellekarcinom | Osteosarkom | Sarkom, Ewing | Ewing Sarkom | Rhabdoid tumor | Nyretumor | Rhabdomyosarkom | Wilms Tumor | Non-Rhabdomyosarcoma Soft Tissue Sarcoma, NosForenede Stater
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National Cancer Institute (NCI)AfsluttetTilbagevendende livmoderkorpussarkom | Kondrosarkom | Tilbagevendende osteosarkom | Gastrointestinal stromal tumor | Clear Cell Sarkom af Nyren | Metastatisk osteosarkom | Ovariesarkom | Tilbagevendende bløddelssarkom hos voksne | Stage III Blødt vævssarkom for voksne | Stadie III uterin sarkom | Stage IV Blødt... og andre forholdForenede Stater
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Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetChordoma | Desmoid Tumor | Tilbagevendende bløddelssarkom i barndommen | Childhood Alveolar Bløddel Sarkom | Angiosarkom i barndommen | Epiteloid sarkom i barndommen | Fibrosarkom i barndommen | Barndoms leiomyosarkom | Liposarkom i barndommen | Malignt mesenchymom i barndommen | Neurofibrosarkom i barndommen | Barndoms... og andre forholdForenede Stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeLeiomyosarkom | Fibrosarkom | Liposarkom | Mesenkymalt chondrosarkom | Stage III blødt vævssarkom AJCC v7 | Stage IV blødt vævssarkom AJCC v7 | Ondartet perifer nerveskedetumor | PEComa | Synovialt sarkom | Epiteloid sarkom | Alveolær blød del sarkom | Udifferentieret højgradigt pleomorfisk knoglesarkom | Myxofibro... og andre forholdForenede Stater, Canada, Puerto Rico
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Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetStage III Blødt vævssarkom for voksne | Stage IV Blødt vævssarkom for voksne | Stadie I Voksen blødt vævssarkom | Stage II Blødt vævssarkom for voksne | Dermatofibrosarcoma Protuberans | Angiosarkom hos voksne | Voksen epiteloid sarkom | Voksen ekstraskeletalt osteosarkom | Voksen fibrosarkom | Voksen leiomyosarkom og andre forholdForenede Stater, Canada, Australien, New Zealand, Puerto Rico
Kliniske forsøg med Cediranib
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Radboud University Medical CenterAfsluttetOndartet ascites | Ondartet pleuraeffusionHolland
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Medical Research CouncilNational Health and Medical Research Council, Australia; AstraZeneca; Cancer... og andre samarbejdspartnereUkendtLivmoderhalskræftDet Forenede Kongerige
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AstraZenecaRoyal Marsden NHS Foundation TrustAfsluttet
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National Cancer Institute (NCI)AfsluttetÆggelederkræft | Primært peritonealt serøst adenokarcinom | Tilbagevendende ovarieepitelkræft | Stadie I Ovarieepitelkræft | Stadie II OvarieepitelkræftForenede Stater
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National Cancer Institute (NCI)AfsluttetTilbagevendende malignt mesotheliom | Avanceret malignt mesotheliom | Epitel mesotheliom | Sarkomatøst mesotheliom | Lokaliseret malignt mesotheliomForenede Stater
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National Cancer Institute (NCI)AfsluttetVoksen kæmpecelleglioblastom | Voksen glioblastom | Gliosarkom hos voksne | Tilbagevendende voksen hjernetumorForenede Stater
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AstraZenecaAfsluttetAdvanced Solid Metastatic TumorDet Forenede Kongerige
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National Cancer Institute (NCI)AfsluttetB-celle kronisk lymfatisk leukæmi | Refraktær kronisk lymfatisk leukæmiForenede Stater
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National Cancer Institute (NCI)AfsluttetIntraokulært melanom | Tilbagevendende melanom | Stadie IV melanom | Ciliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Ekstraokulært ekstensionsmelanom | Akralt lentiginøst malignt melanom | Lentigo Maligna Malignt melanom | Overfladisk... og andre forholdCanada
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AstraZenecaAktiv, ikke rekrutterendeFaste tumorerDet Forenede Kongerige, Canada