Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer : protocol of a multicenter, open-label, randomized phase 2 trial
2023 Translational Cancer Research. All rights reserved..
Background: Currently preferred single-agent nonplatinum chemotherapy or its combination with bevacizumab results in a low response rate and modest survival benefit for platinum-resistant recurrent ovarian cancer, and thus more effective regimens are needed. In our previous phase 2 trial, apatinib plus etoposide showed promising efficacy and an acceptable safety profile in platinum-resistant recurrent ovarian cancer patients. Due to the single-arm design, the role of apatinib still needs to be determined.
Methods: In this phase 2 trial, 54 adult patients with platinum-resistant current ovarian cancer will be recruited at 17 sites in China. Patients with prior administration of small-molecule tyrosine kinase inhibitors or etoposide will be excluded. Patients will be randomized (1:1) to receive apatinib (375 mg, orally, once daily) alone or in combination with etoposide (50 mg, orally on days 1-14 of each 21-day cycle) until disease progression or intolerable toxicity. Randomization will be performed using a computerized central randomization system, stratified by platinum resistance for the first time (yes or no). Imaging examinations will be conducted every 6 weeks. The primary endpoint is the objective response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (version 1.1), which will be compared between groups using the Cochran-Mantel-Haenszel test.
Discussion: This study will provide prospective data of 2 experimental regimens using a randomized design. It will help determine whether apatinib monotherapy can provide favorable clinical benefits or needs to be combined with chemotherapy to be effective.
Trial Registration: ClinicalTrials.gov Identifier: NCT04383977. It was registered on May 12, 2020.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Translational cancer research - 12(2023), 10 vom: 31. Okt., Seite 2959-2967 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hou, Zhiguo [VerfasserIn] |
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| Links: |
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| Themen: |
Apatinib |
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| Anmerkungen: |
Date Revised 17.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT04383977 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.21037/tcr-23-1924 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364609761 |
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| 245 | 1 | 0 | |a Efficacy, safety and pharmacokinetics of apatinib plus etoposide versus apatinib alone for platinum-resistant recurrent ovarian cancer |b protocol of a multicenter, open-label, randomized phase 2 trial |
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| 500 | |a ClinicalTrials.gov: NCT04383977 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 2023 Translational Cancer Research. All rights reserved. | ||
| 520 | |a Background: Currently preferred single-agent nonplatinum chemotherapy or its combination with bevacizumab results in a low response rate and modest survival benefit for platinum-resistant recurrent ovarian cancer, and thus more effective regimens are needed. In our previous phase 2 trial, apatinib plus etoposide showed promising efficacy and an acceptable safety profile in platinum-resistant recurrent ovarian cancer patients. Due to the single-arm design, the role of apatinib still needs to be determined | ||
| 520 | |a Methods: In this phase 2 trial, 54 adult patients with platinum-resistant current ovarian cancer will be recruited at 17 sites in China. Patients with prior administration of small-molecule tyrosine kinase inhibitors or etoposide will be excluded. Patients will be randomized (1:1) to receive apatinib (375 mg, orally, once daily) alone or in combination with etoposide (50 mg, orally on days 1-14 of each 21-day cycle) until disease progression or intolerable toxicity. Randomization will be performed using a computerized central randomization system, stratified by platinum resistance for the first time (yes or no). Imaging examinations will be conducted every 6 weeks. The primary endpoint is the objective response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (version 1.1), which will be compared between groups using the Cochran-Mantel-Haenszel test | ||
| 520 | |a Discussion: This study will provide prospective data of 2 experimental regimens using a randomized design. It will help determine whether apatinib monotherapy can provide favorable clinical benefits or needs to be combined with chemotherapy to be effective | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT04383977. It was registered on May 12, 2020 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Apatinib | |
| 650 | 4 | |a etoposide | |
| 650 | 4 | |a ovarian cancer | |
| 650 | 4 | |a platinum | |
| 650 | 4 | |a protocol | |
| 700 | 1 | |a Lan, Chunyan |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Xin |e verfasserin |4 aut | |
| 700 | 1 | |a Salcedo-Hernández, Rosa A |e verfasserin |4 aut | |
| 700 | 1 | |a El-Tawab, Sally |e verfasserin |4 aut | |
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