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A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma (AMETHYST)

4 novembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

Fase

  • Fase 2
  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria

  1. 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.
  2. At least 18 years old
  3. Measurable disease (M-protein and/or free light chains) in serum and/or urine
  4. Willing and able to comply the study protocol visits and assessments
  5. Willing to use highly effective methods of birth control (see section 7.1.3)
  6. Written informed consent prior to study participation

Exclusion Criteria:

  1. Types of Multiple Myeloma previously shown to be irresponsive to dexamethasone monotherapy during the last 6 months
  2. Plasma cell leukemia
  3. 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
  4. 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
  5. Treatment with oral or injectable (including intra-articular) corticosteroids (CS) within 4 weeks prior to Screening Visit. Inhaled and dermal corticosteroid formulations are allowed
  6. Subjects who have received a chemotherapeutic treatment cycle including dexamethasone within 4 weeks prior to the Screening Visit
  7. 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
  8. Active infection requiring systemic treatment
  9. Planned major surgery during the study period or had undergone major surgery within 30 days prior to the Screening visit
  10. Pregnancy or breastfeeding
  11. 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
  12. Participation in another clinical investigation less than 4 weeks prior to inclusion
  13. 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.
  14. 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
  15. The subject is unwilling or unable to follow the procedures outlined in the protocol
  16. The subject is mentally or legally incapacitated
  17. Persons who are in a relationship of dependence to the Investigator or the Sponsor

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: IV Liposomal Dexamethasone
IV Liposomal Dexamethasone given 1 to 4 times in total over period of maximally 4 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Lasso di tempo: Week 8
Week 8

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Response according to IMWG Criteria
Lasso di tempo: 4 and 8 weeks after 1st dose
4 and 8 weeks after 1st dose
Percentage change of myeloma-related measures
Lasso di tempo: up to 8 weeks after 1st dose
up to 8 weeks after 1st dose
Quality of life questionnaire
Lasso di tempo: up to 8 weeks after 1st dose
up to 8 weeks after 1st dose
Peak Plasma Concentration (Cmax)
Lasso di tempo: during 1st 4 weeks
during 1st 4 weeks
Area under the plasma concentration versus time curve (AUC)
Lasso di tempo: during 1st 4 weeks
during 1st 4 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Stefan Wilop, MD, RWTH University Clinic Aachen

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2017

Completamento primario (Effettivo)

1 agosto 2020

Completamento dello studio (Effettivo)

1 agosto 2020

Date di iscrizione allo studio

Primo inviato

3 gennaio 2017

Primo inviato che soddisfa i criteri di controllo qualità

24 gennaio 2017

Primo Inserito (Stima)

26 gennaio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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