- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00717522
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
6. november 2019 opdateret af: Celgene
A Phase 2, Multicenter, Open-label, Single Arm, Two-stage Study to Evaluate the Efficacy and Safety of CC-4047 (Pomalidomide) in Patients With Advanced Soft Tissue Sarcomas Who Have Relapsed or Are Refractory to Systemic Anticancer Therapy
The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Santa Monica, California, Forenede Stater, 90403
- Sarcoma Oncology Center
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Idaho
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Cancer Center
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Must be > 18 years of age
- Must have histologically confirmed soft tissue sarcoma
- Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens
- Must have measurable or evaluable disease determined as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Must have documented disease progression (PD) determined as per RECIST criteria within 3 months prior to study enrollment
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
- Pregnant or lactating females
- Prior therapy with thalidomide or lenalidomide
- Prior use of experimental/investigational drug therapy < 3 months prior to treatment initiation
- Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment initiation
- Prior radiotherapy < 3 weeks prior to treatment initiation
- Prior major surgery < 3 weeks prior to treatment initiation
- Absolute neutrophil count (ANC) < 1.5 x 109 cells/L
- Platelet count < 100 x 109cells/L
- Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in the presence of demonstrable liver metastases
- Known active central nervous system (CNS) metastases
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Pomalidomide
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Tidsramme: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
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An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study.
It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology.
A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
For more details, please see the Adverse Events section of this record.
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AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
Tidsramme: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).
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Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria.
Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started.
For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
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Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Abderrahim Fandi, MD, Celgene
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2008
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
16. juli 2008
Først indsendt, der opfyldte QC-kriterier
16. juli 2008
Først opslået (Skøn)
17. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CC-4047-STSAR-001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Blødt vævssarkom
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University GhentOsteology FoundationAktiv, ikke rekrutterende
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OnxeoSpectrum Pharmaceuticals, IncAfsluttetDosiseskalering: Faste tumorer | MTD: Soft Tissue SarkomerDanmark, Det Forenede Kongerige
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AmgenRekrutteringAvancerede solide tumorer | Kirsten Rat Sarcoma (KRAS) pG12C mutationForenede Stater, Italien, Taiwan, Spanien, Det Forenede Kongerige, Australien, Østrig, Tyskland, Belgien, Japan, Holland, Korea, Republikken, Canada
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Institut CurieUNICANCERAfsluttetEwing Sarcoma familie af tumorerFrankrig
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Istituto Ortopedico RizzoliRegione Emilia-RomagnaAfsluttetEwing Sarcoma familie af tumorerDet Forenede Kongerige, Italien
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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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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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Boehringer IngelheimIkke rekrutterer endnuAvanceret blødt vævssarkom | Udifferentieret Pleomorphic Sarcoma (UPS) | Myxofibrosarkom (MFS)
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National Cancer Institute (NCI)AfsluttetStage IV Blødt vævssarkom for voksne | Rhabdomyosarkom hos voksne | Metastatisk Childhood Soft Tissue Sarkom | Alveolær rabdomyosarkom i barndommen | Embryonal rabdomyosarkom i barndommen | Ubehandlet rabdomyosarkom i barndommenForenede Stater, Canada, Australien, New Zealand
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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
Kliniske forsøg med Pomalidomid
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Kirby InstituteAktiv, ikke rekrutterendeHøjgradig pladeepitellæsion (HSIL)Australien
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MegalabsIkke rekrutterer endnu
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CelgeneAfsluttetSystemisk sklerose | Sklerodermi, systemisk | Systemisk sklerodermi | Interstitiel lungesygdom | Sclerose, systemiskForenede Stater, Spanien, Frankrig, Australien, Italien, Schweiz, Tyskland, Polen, Det Forenede Kongerige, Den Russiske Føderation
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Stanford UniversityCelgene CorporationTrukket tilbage
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CelgeneAfsluttetMyelomatoseCanada, Danmark, Australien, Belgien, Frankrig, Tyskland, Italien, Holland, Den Russiske Føderation, Spanien, Sverige, Schweiz, Det Forenede Kongerige, Tjekkiet, Grækenland
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Multiple Myeloma Research ConsortiumEli Lilly and Company; GlaxoSmithKline; AbbVie; Takeda; Genentech, Inc.; Celgene... og andre samarbejdspartnereRekrutteringRecidiverende refraktært myelomatoseForenede Stater
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CelgeneAfsluttetMyelomatoseBelgien, Det Forenede Kongerige, Italien, Tyskland, Sverige, Danmark, Norge, Spanien
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IRCCS Policlinico S. MatteoRekrutteringAL AmyloidoseItalien
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University of LeedsCelgene Corporation; Oncolytics Biotech; Myeloma UKUkendtMyelomatoseDet Forenede Kongerige