- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03033316
A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma (AMETHYST)
4. november 2020 opdateret af: Enceladus Pharmaceuticals BV
A Phase I-IIa, Open Label, Multi-Center, Dose Escalating Study to Evaluate the Safety of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate (Oncocort) as Monotherapy in Patients With Previously Treated Progressive Multiple Myeloma
Oncocort Dexamethasone sodium phosphate encapsulated in so-called 'long-circulating' PEGylated liposomes is in development with the prospect of providing enhanced and prolonged lesion uptake of dexamethasone and therefore increased therapeutic benefit over existing formulations of dexamethasone in Multiple Myeloma.
The current trial is a first-in-man study with Oncocort monotherapy with the objective to assess safety, tolerability, efficacy and dose response after short-term treatment with repeated infusions.
Studieoversigt
Detaljeret beskrivelse
This open label multicenter study will evaluate the safety and efficacy of I.V. Oncocort Dexamethasone sodium phosphate given as a short term induction therapy in Multiple Myeloma patients.
It consist of a Phase 1 part with a maximum number of 5 ascending dose levels while additional patients will be treated in the Phase 2a part with the recommended phase 2 dose to obtain additional safety data and preliminary efficacy data in multiple myeloma patients.
For the dose escalation phase 1 part, 3 patients per dose level will be enrolled.
If one patient reaches DLT, another 3 patients will be enrolled in the same dose level.
If two or more patients reach DLT in one dose level, maximum tolerated dose (MTD) is defined at the last dose level beneath DLT.
Not more than 5 dose level groups are anticipated for this part of the study.
MTD will be the Recommended Phase II Dose (RPTD) for the phase IIa part of the study.
For the phase 2a part, 7 additional patients will be enrolled at the RPTD dose level, bringing the total number of patients monitored for responses at this dose level to at least 10.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Fase 2
- Fase 1
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
- Previously diagnosed symptomatic MM according to International Myeloma Working Group (IMWG) criteria 1.1. Previously treated with at least two therapy lines including at least one proteasome-inhibitor and at least one immunomodulatory drug 1.2. Relapse after or progressive disease under last therapy according to IMWG criteria.
- At least 18 years old
- Measurable disease (M-protein and/or free light chains) in serum and/or urine
- Willing and able to comply the study protocol visits and assessments
- Willing to use highly effective methods of birth control (see section 7.1.3)
- Written informed consent prior to study participation
Exclusion Criteria:
- Types of Multiple Myeloma previously shown to be irresponsive to dexamethasone monotherapy during the last 6 months
- Plasma cell leukemia
- Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive HIV antibody screen
- Severe abnormal organ function function or laboratory results at the time of the Screening Visit: WBC <3.0 g/L, ANC <1.5 G/L, PLT <50 G/L, Sodium <135 mmol/L or >150 mmol/L, potassium <3.5 mmol/L or >5.5 mmol/L, calcium <2.0 mmol/L or > 2.9mmol/L, phosphorus <0.8 mmol/L, total bilirubin >1.5x ULN, AP >2.5x ULN, gammaGT >3x ULN, ALT >3x ULN, CK >2.5x ULN, Creatinine >2x ULN, fasting glucose >250 mg/dL, albumin <3 g/dL, cholesterol > 300 mg/dL
- Treatment with oral or injectable (including intra-articular) corticosteroids (CS) within 4 weeks prior to Screening Visit. Inhaled and dermal corticosteroid formulations are allowed
- Subjects who have received a chemotherapeutic treatment cycle including dexamethasone within 4 weeks prior to the Screening Visit
- Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to intravenous medications, biologic therapy or IV radiocontrast agents
- Active infection requiring systemic treatment
- Planned major surgery during the study period or had undergone major surgery within 30 days prior to the Screening visit
- Pregnancy or breastfeeding
- Any clinically significant hepatic, renal, cardiac, pulmonary, gastrointestinal, metabolic or endocrine disturbances, other medical or psychiatric condition, or clinically relevant abnormal values on any investigation, in the opinion of the Investigator, that could make the subject unsuitable for the study, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study, including severe neuropathies or other painful conditions that might interfere with pain evaluation
- Participation in another clinical investigation less than 4 weeks prior to inclusion
- The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
- The subject is unwilling or unable to follow the procedures outlined in the protocol
- The subject is mentally or legally incapacitated
- Persons who are in a relationship of dependence to the Investigator or the Sponsor
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 |
---|---|
Eksperimentel: IV Liposomal Dexamethasone
IV Liposomal Dexamethasone given 1 to 4 times in total over period of maximally 4 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsramme: Week 8
|
Week 8
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Response according to IMWG Criteria
Tidsramme: 4 and 8 weeks after 1st dose
|
4 and 8 weeks after 1st dose
|
Percentage change of myeloma-related measures
Tidsramme: up to 8 weeks after 1st dose
|
up to 8 weeks after 1st dose
|
Quality of life questionnaire
Tidsramme: up to 8 weeks after 1st dose
|
up to 8 weeks after 1st dose
|
Peak Plasma Concentration (Cmax)
Tidsramme: during 1st 4 weeks
|
during 1st 4 weeks
|
Area under the plasma concentration versus time curve (AUC)
Tidsramme: during 1st 4 weeks
|
during 1st 4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Stefan Wilop, MD, RWTH University Clinic Aachen
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. januar 2017
Primær færdiggørelse (Faktiske)
1. august 2020
Studieafslutning (Faktiske)
1. august 2020
Datoer for studieregistrering
Først indsendt
3. januar 2017
Først indsendt, der opfyldte QC-kriterier
24. januar 2017
Først opslået (Skøn)
26. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Myelomatose
- Neoplasmer, Plasmacelle
- Lægemidlers fysiologiske virkninger
- Autonome agenter
- Agenter fra det perifere nervesystem
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Dexamethason
Andre undersøgelses-id-numre
- 14-097
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 Dexamethason
-
Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHRekruttering
-
Shanghai Jiao Tong University Affiliated Sixth...AfsluttetAnalgesi | Tid | Brachial Plexus Blok | Skulderkirurgi | Dexamethason | Intravenøs medicinbrugKina
-
Vanderbilt University Medical CenterAfsluttetAstma | KrydsForenede Stater
-
Centre hospitalier de l'Université de Montréal...AfsluttetForebyggelse af overfølsomhedsreaktioner over for paclitaxelCanada
-
University of BelgradeAfsluttet
-
Cairo UniversityUkendt
-
Dr. Stephen ChoiThe Physicians' Services Incorporated FoundationAfsluttetSkulderkirurgi | NerveblokCanada
-
Ottawa Hospital Research InstituteAfsluttetSmertesyndrom | Brystkræft i tidligt stadieCanada
-
Poznan University of Medical SciencesRekrutteringHåndledsskader | Håndskader | Håndskader og lidelser | Håndsyge | HåndledssygdomPolen
-
General Hospital of Ningxia Medical UniversityIkke rekrutterer endnu