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JOURNAL ONKOLOGIE – STUDIE
SIRACUSA

A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

Rekrutierend

NCT-Nummer:
NCT05383352

Studienbeginn:
Mai 2022

Letztes Update:
01.04.2024

Wirkstoff:
Irinotecan liposome injection, Folinic Acid, 5-Fluorouracil

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Ipsen

Collaborator:
-

Studienleiter

Ipsen Medical Director
Study Director
Ipsen

Kontakt

Studienlocations
(3 von 40)

University Hospital Dresden
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Caritasklinikum Saarbruecken St Theresia
66113 Saarbrücken
(Saarland)
GermanyAbgebrochen» Google-Maps
Universitätsklinikum Ulm -Zentrum Für Innere Medizin
89081 Ulm
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Peninsula and Southeast Oncology - Frankston Private Hospital
Frankston
AustraliaRekrutierend» Google-Maps
Institut BERGONIE Centre de Lutte Contre le Cancer
Bordeaux
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Benite Cedex
FranceAbgebrochen» Google-Maps
Mav Korhaz Es Kozponti Rendelointezet
Budapest
HungaryRekrutierend» Google-Maps
Clinexpert Kft Fázis I. Vizsgálóhely
Gyöngyös
HungaryRekrutierend» Google-Maps
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
Bologna
ItalyAbgebrochen» Google-Maps
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Modena
Modena
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Torrette
ItalyRekrutierend» Google-Maps
Hospital Senhora Da Oliveira - Hso-Epe
Guimarães
PortugalRekrutierend» Google-Maps
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisboa
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
Porto
PortugalZurückgezogen» Google-Maps
Hospital Del Mar Servicio de Oncologia
Barcelona
SpainZurückgezogen» Google-Maps
Hospital Universitario Vall D Hebron
Barcelona
SpainRekrutierend» Google-Maps
Instituto Oncologico Dr Rosell Lor
Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari de Lleida Arnaud de Villanova
Lleida
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon Y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Quiron Salud
28223 Madrid
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla
Santander
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario de Santiago de Compostela -Chus
Santiago De Compostela
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The aim of this study is to compare Onivyde manufactured at two different production sites in

adult participants with advanced cancer in the pancreas.

Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP)

and Reference Product (RP) Onivyde in line with its approved indication. The order in which

they receive them depends on the group to which they are randomly assigned, this will be

referred to as the crossover phase.

The average study duration for each participant until end of crossover phase is estimated to

be approximately 3 months. After completion of the crossover phase, participants who in the

opinion of the investigator will benefit from the treatment will be offered to enter the

extension phase where they will receive the commercial Onivyde (RP) until disease

progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma

is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of

the body.

Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after

disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil

(5-FU) and leucovorin (LV).

Ein-/Ausschlusskriterien

Inclusion Criteria :

- Participant must be ≥18 years of age at the time of signing the informed consent.

- Participants who have histological or cytologically confirmed adenocarcinoma of the

pancreas.

- Participants with an initial diagnosis of progressive metastatic disease

- Participants with a confirmed diagnosis of metastatic adenocarcinoma of the pancreas

with disease progression following gemcitabine-based therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

- Adequate haematological parameters

- Adequate hepatic function

- Adequate renal function

- Adequate coagulation

- No clinically significant abnormalities in urinalysis results

- Electrocardiogram (ECG) without any clinically significant findings

- Participants known to be infected with controlled human immunodeficiency virus (HIV)

- Male and female participants: Contraceptive use by men or women should be consistent

with local regulations regarding the methods of contraception for those participating

in clinical studies

- Capable of giving signed informed consent

Exclusion Criteria :

- Have only localised advanced disease.

- History of any second malignancy in the last 2 years.

- Known history of central nervous system metastases

- Clinically significant gastrointestinal disorder including hepatic disorders,

bleeding, inflammation, occlusion, diarrhoea >Grade 1, malabsorption syndrome,

ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.

- Concurrent illnesses that would be a relative contraindication to trial participation

such as active cardiac or liver disease

- Active infection or an unexplained fever >38.5°C on the first scheduled day of dosing

- Neuroendocrine tumour (carcinoid, islet cell) or acinar pancreatic carcinoma

- History of interstitial lung disease, history of slowly progressive dyspnoea and

unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary

hypersensitivity pneumonitis or multiple allergies.

- Exposure to a non-liposomal irinotecan or SN-38 based regimen within 4 weeks prior to

randomisation, or exposure to Onivyde or other irinotecan based liposomal products

within 6 weeks prior to randomisation

- Major surgery, other than diagnostic surgery, within 4 weeks prior to randomisation

- Participants who have received a live vaccine within 4 weeks prior to randomisation.

- Use of strong CYP3A inhibitors or inducers, or strong inhibitors of UGT1A1.

- Investigational therapy administered within 4 weeks, or within a time interval less

than at least 5 half-lives of the investigational agent, whichever is longer, prior to

study intervention on Cycle 1 Day 1

- Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.

- Homozygous for the UGT1A1*28 allele.

- Known hypersensitivity to any of the components of Onivyde injection, other liposomal

products, or any components of 5-FU, or LV

- Presence of any contraindications outlined in the Contraindications or Warnings and

Precautions sections of the IB for Onivyde, or in the prescribing information for 5-FU

or LV.

- Participants who, in the opinion of the investigator, have symptoms or signs

suggestive of clinically unacceptable deterioration of the primary disease at the time

of screening

- Any other medical or social condition deemed by the investigator to be likely to

interfere with a participant's ability to sign informed consent, cooperate and

participate in the study, or interfere with the interpretation of the results

Studien-Rationale

Primary outcome:

1. Maximum (peak) plasma drug concentration (Cmax) of encapsulated irinotecan for Test relative to and Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

2. Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t) of encapsulated irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

3. Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞) of encapsulated irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

Secondary outcome:

1. Maximum (peak) plasma drug concentration (Cmax) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

2. Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t)) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

3. Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

4. Time to maximum plasma concentration (Tmax) of encapsulated and total irinotecan over 15-days for each Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

5. Apparent clearance of drug from plasma (CL) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

6. Apparent volume of distribution (VZ) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

7. Terminal half-life (t1/2) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

8. Apparent terminal elimination rate constant (λZ) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))

9. Percentage of participants with treatment-emergent adverse events (TEAEs) treatment-related leading to discontinuations, or to death (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))):
Including treatment-emergent serious adverse events

10. Percentage of participants with clinically significant abnormal values (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))):
It includes clinically significant abnormal laboratory results, physical examination findings, Electrocardiogram (ECG) and vital signs

Studien-Arme

  • Experimental: Sequence RT: Reference Product followed by Test Product
    Cycle 1 (Crossover Phase) Day 1: One dose Onivyde® Reference product + 5-FU/LV. Cycle 1 (Crossover Phase) Day 15: One dose Onivyde Test product + 5-FU/LV Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV
  • Experimental: Sequence TR: Test Product followed by Reference Product
    Cycle 1 (Crossover Phase) Day 1: One dose Onivyde Test product + 5-FU/LV. Cycle 1 (Crossover Phase) Day 15: One dose Onivyde® Reference product + 5-FU/LV. Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV.

Geprüfte Regime

  • Irinotecan liposome injection (Onivyde® Reference product):
    Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
  • Irinotecan liposome injection (Onivyde Test product):
    Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase)
  • Irinotecan liposome injection (Onivyde Test product):
    Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase)
  • Irinotecan liposome injection (Onivyde® Reference product):
    Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
  • Folinic Acid (Leucovorin (LV)):
    LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle
  • 5-Fluorouracil (5-FU):
    5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle

Quelle: ClinicalTrials.gov


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