EPIK-O/ENGOT-OV61 : alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study)
NCT04729387 (ClinicalTrials.gov).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Future oncology (London, England) - 18(2022), 31 vom: 05. Okt., Seite 3481-3492 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Konstantinopoulos, Panagiotis A [VerfasserIn] |
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| Links: |
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| Themen: |
08W5N2C97Q |
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| Anmerkungen: |
Date Completed 15.12.2022 Date Revised 27.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT04729387 Citation Status MEDLINE |
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| doi: |
10.2217/fon-2022-0666 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM345840100 |
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| 100 | 1 | |a Konstantinopoulos, Panagiotis A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a EPIK-O/ENGOT-OV61 |b alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study) |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 15.12.2022 | ||
| 500 | |a Date Revised 27.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04729387 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) have a poor prognosis, and their management represents a substantial unmet medical need. Preclinical data and results from a phase Ib trial demonstrated the efficacy and tolerability of the combination of the α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib plus the poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor olaparib in platinum-resistant, non-BRCA-mutated ovarian cancer. Here, we describe the study design and rationale for the phase III, multicenter, open-label, randomized, active-controlled EPIK-O/ENGOT-OV61 trial investigating alpelisib in combination with olaparib compared with standard-of-care chemotherapy in patients with platinum-resistant or -refractory HGSOC with no germline BRCA mutation. Progression-free survival (blinded independent review committee) is the primary end point. Overall survival is a key secondary end point. Clinical Trial Registration:: NCT04729387 (ClinicalTrials.gov) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a PARP inhibitor | |
| 650 | 4 | |a PI3K inhibitor | |
| 650 | 4 | |a alpelisib | |
| 650 | 4 | |a chemotherapy | |
| 650 | 4 | |a high-grade serous ovarian cancer | |
| 650 | 4 | |a olaparib | |
| 650 | 4 | |a ovarian cancer | |
| 650 | 7 | |a olaparib |2 NLM | |
| 650 | 7 | |a WOH1JD9AR8 |2 NLM | |
| 650 | 7 | |a Alpelisib |2 NLM | |
| 650 | 7 | |a 08W5N2C97Q |2 NLM | |
| 650 | 7 | |a Phthalazines |2 NLM | |
| 700 | 1 | |a Gonzalez-Martin, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Cruz, Felipe Melo |e verfasserin |4 aut | |
| 700 | 1 | |a Friedlander, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Glasspool, Rosalind |e verfasserin |4 aut | |
| 700 | 1 | |a Lorusso, Domenica |e verfasserin |4 aut | |
| 700 | 1 | |a Marth, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Monk, Bradley J |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae-Weon |e verfasserin |4 aut | |
| 700 | 1 | |a Hinson, Patsy |e verfasserin |4 aut | |
| 700 | 1 | |a Ajipa, Olga |e verfasserin |4 aut | |
| 700 | 1 | |a Pretre, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Matulonis, Ursula A |e verfasserin |4 aut | |
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