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Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients

12. januar 2020 opdateret af: Seoul National University Hospital

A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer

This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects are dosed with Bortezomib and PLD for a maximum of 6 cycles of 4 weeks. The response rate is evaluated with CT according to RECIST criteria ver 1.1. The efficacy and safety of the drug are assessed at the time of recurrence, at the time of death, or after 24 months after the end of the study drug administration.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

44

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Gyenggi DO
      • Seongnam Si, Gyenggi DO, Korea, Republikken, 463707
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Kidong Kim, MD

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer based on histologic findings obtained from biopsy/surgery and having a histologic type of high-grade serous cancer.
  • In the absence of a mutation of the BRCA gene (no germline mutation should be identified, not in the case of a somatic mutation)
  • Recurrence within 6 months after platinum-based chemotherapy.
  • ECOG performance 2 points or less.
  • Blood tests performed within 2 weeks of enrollment meet the following results: Neutrophil > 1,500/mm3; Platelet > 100,000/mm3; Hemoglobin > 9.0 g/dL; Total bilirubin < 1.5 x upper limit of normal (ULN); AST/ALT < 3.0 x ULN (or < 5 x ULM in case of liver metastases); Creatinine < 1.5 x ULN; Electrolytes should be within normal limits.
  • Patients who understand the content of the study description and voluntarily agree in writing.
  • Patients who are willing and able to adhere to the visit schedule, treatment plan, laboratory tests, and other testing procedures.

Exclusion Criteria:

  • Patients previously treated with three or more anticancer regimens. Maintenance therapy is not considered a separate regimen (eg> paclitaxel-carboplatin-bevacizumab therapy). In the combined chemotherapy, when one drug is subtracted due to toxicity, the regimen is not counted as a change (Eg> paclitaxel-carboplatin chemotherapy, paclitaxel was discontinued due to neurotoxicity and carboplatin alone was not considered as a change of regimen).
  • Previous refractory to ovarian cancer chemotherapy.
  • Patients diagnosed with other tumors other than ovarian cancer for the last 5 years (not CIS).
  • pregnant woman.
  • Patients with uncontrolled infection.
  • In the case of congenital immune disease or acquired immune deficiency syndrome.
  • Women in lactation.
  • History with Grade 3 or higher peripheral neuropathy.
  • History of hypersensitivity reactions to PLD or bortezomib.
  • If the physician is judged to have any serious illness or medical condition for which the patient is not suitable for the study.
  • Patients with confirmed BRCA somatic mutations.
  • Patients with acute diffuse infiltrative lung disease and cardiovascular disease.

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: Pegylated liposomal doxorubicin plus Bortezomib combination
At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
Medicin: Pegylated liposomal doxorubicin plus Bortezomib
Pegylated liposomal doxorubicin 40mg/m2 subcutaneous for 60 - 90 minutes at day 4 plus Bortezomib 1.3mg/m2 subcutaneous injection at day 1,4,8,11 for 6 cycles

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall response rate
Tidsramme: up to 6yr
In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
up to 6yr
Partial response rate
Tidsramme: up to 6yr
The percentage of patients who received a confirmed treatment response over a partial response according to the RECIST criteria version 1.1 in the modified ITT analysis group. The evaluation is based on the researchers of each participating organization.
up to 6yr

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete remission rate
Tidsramme: up to 6yr
The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group
up to 6yr
Progression-free survival
Tidsramme: up to 2yr
Patients who have recurred disease after the end of the administration are identified and measured.
up to 2yr
Overall survival
Tidsramme: up to 6yr
Patients who died from illness after the start of treatment were identified and measured.
up to 6yr
Response period
Tidsramme: up to 5yr
duration of objective response period
up to 5yr
Quality of life
Tidsramme: up to 6yr
Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.
up to 6yr
Adverse drug reactions
Tidsramme: up to 6yr
To be evaluated according to NCI CTCAE version 4.03 Frequency of occurrence of each drug adverse reaction and 95% confidence interval, grade 3 or higher, the frequency of adverse drug events and 95% confidence interval.
up to 6yr
Genetic susceptibility assessment
Tidsramme: up to 6yr
Response rate in subjects with CCNE1 amplification.
up to 6yr

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

15. maj 2018

Primær færdiggørelse (Forventet)

1. marts 2022

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

29. marts 2018

Først indsendt, der opfyldte QC-kriterier

25. april 2018

Først opslået (Faktiske)

26. april 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EBLIN

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Serøst karcinom af høj grad

Kliniske forsøg med Pegylated liposomal doxorubicin plus Bortezomib

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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