Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

First-line Olaparib Combined With Bevacizumab Maintenance Therapy

29 juni 2022 uppdaterad av: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcomes of First-line Olaparib Combined With Bevacizumab Maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Real-world Study

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize that olaparib plus bevacizumab maintenance therapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy.

The secondary objectives are to evaluate the outcomes of olaparib plus bevacizumab maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib plus bevacizumab dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.

Studietyp

Observationell

Inskrivning (Förväntat)

50

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Sannolikhetsprov

Studera befolkning

Patients diagnosed with HGSOC who started first-line olaparib plus bevacizumab maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.

Beskrivning

Inclusion Criteria:

  • Female Patients must be ≥18 years old at diagnosis.
  • Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
  • Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
  • Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
  • Patients who were still in CR or PR before receiving maintenance therapy
  • Patients who received at least one dose of olaparib plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression

Exclusion Criteria:

  • Patient with multiple primary cancers as reported in EMR
  • Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
  • Any previous treatment with PARP inhibitor.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
  • Patients with symptomatic uncontrolled brain metastases.
  • Any other concerns related to decreased efficacy and safety of maintenance therapy.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
olaparib plus bevacizumab treatment group
olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.
Läkemedel: olaparib plus bevacizumab maintenance therapy
First-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
1-yr PFS rate
Tidsram: 12 months after date of first dose
the investigator assessed progression-free survival (PFS) at 1 year
12 months after date of first dose

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-yr PFS rate
Tidsram: 24 months after date of first dose
the investigator assessed progression-free survival (PFS) at 2 year
24 months after date of first dose
Median PFS
Tidsram: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
median progression-free survival
Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
mTFST
Tidsram: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
median Time to First Subsequent Therapy or death
Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Post-progression treatment
Tidsram: Through study completion, an average of 1 year
The proportion of patients receiving each treatment after first progression through study completion, an average of 1 year
Through study completion, an average of 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 juni 2022

Primärt slutförande (Förväntat)

1 september 2022

Avslutad studie (Förväntat)

1 december 2022

Studieregistreringsdatum

Först inskickad

8 december 2021

Först inskickad som uppfyllde QC-kriterierna

29 juni 2022

Första postat (Faktisk)

1 juli 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juni 2022

Senast verifierad

1 juni 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ESR-20-20889-01

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Ovariella neoplasmer

Kliniska prövningar på olaparib plus bevacizumab maintenance therapy

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Moldova

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera