Phase I/Ib study of crenolanib with ramucirumab and paclitaxel as second-line therapy for advanced esophagogastric adenocarcinoma
Purpose Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibit...
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| Veröffentlicht in: | Cancer chemotherapy and pharmacology Jg. 89; H. 2; S. 255 - 265 |
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| Sprache: | Englisch |
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Berlin/Heidelberg
Springer Berlin Heidelberg
01.02.2022
Springer Nature B.V |
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| ISSN: | 0344-5704, 1432-0843, 1432-0843 |
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| Abstract | Purpose
Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab.
Methods
Patients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m
2
intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD.
Results
We enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23–78%] and the objective response rate (ORR) was 42% (95% CI 15–72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor.
Conclusions
The addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID.
Clinical trial registration
NCT03193918. June 19, 2017. |
|---|---|
| AbstractList | Purpose
Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab.
Methods
Patients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m
2
intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD.
Results
We enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23–78%] and the objective response rate (ORR) was 42% (95% CI 15–72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor.
Conclusions
The addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID.
Clinical trial registration
NCT03193918. June 19, 2017. Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab.PURPOSEPaclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab.Patients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m2 intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD.METHODSPatients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m2 intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD.We enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23-78%] and the objective response rate (ORR) was 42% (95% CI 15-72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor.RESULTSWe enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23-78%] and the objective response rate (ORR) was 42% (95% CI 15-72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor.The addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID.CONCLUSIONSThe addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID.NCT03193918. June 19, 2017.CLINICAL TRIAL REGISTRATIONNCT03193918. June 19, 2017. PurposePaclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab.MethodsPatients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m2 intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD.ResultsWe enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23–78%] and the objective response rate (ORR) was 42% (95% CI 15–72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor.ConclusionsThe addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID.Clinical trial registrationNCT03193918. June 19, 2017. Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One potential resistance mechanism to VEGFR2 inhibition is activation of the PDGF/PDGFR pathway, which can be blocked by the selective inhibitor crenolanib. Therefore, we performed a phase I/Ib study of crenolanib in combination with paclitaxel/ramucirumab. Patients with metastatic esophagogastric adenocarcinoma refractory to first-line therapy received escalating doses of crenolanib [60 mg twice daily (BID) to 100 mg three times daily (TID)] in combination with paclitaxel 80 mg/m intravenously on days 1, 8 and 15 and ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary objective was to determine the maximally tolerated dose (MTD) of crenolanib. Additional patients were enrolled in the dose expansion cohort to assess 6-month progression-free survival (PFS) at the MTD. We enrolled 19 patients in the dose escalation phase and 8 patients in the dose expansion phase at the MTD of crenolanib 100 mg BID. Common grade 3/4 treatment-emergent adverse events included leukopenia (19%), anemia (11%) and neutropenia (11%). In the 14 patients treated at the MTD, 6-month PFS was 43% [95% confidence interval (CI) 23-78%] and the objective response rate (ORR) was 42% (95% CI 15-72%). The trial was terminated early due to withdrawal of crenolanib by the sponsor. The addition of crenolanib to paclitaxel/ramucirumab is safe and well-tolerated at a dose level up to 100 mg BID. NCT03193918. June 19, 2017. |
| Author | Ilson, David H. Capanu, Marinela Won, Elizabeth Li, Jia Desai, Avni M. Ku, Geoffrey Y. Kelsen, David P. Janjigian, Yelena Y. Greally, Megan Chou, Joanne F. Chalasani, Sree B. Moy, Ryan H. |
| Author_xml | – sequence: 1 givenname: Ryan H. orcidid: 0000-0002-0507-8590 surname: Moy fullname: Moy, Ryan H. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center, Division of Hematology and Oncology, Department of Medicine, Columbia University Medical Center – sequence: 2 givenname: Megan surname: Greally fullname: Greally, Megan organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 3 givenname: Joanne F. surname: Chou fullname: Chou, Joanne F. organization: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center – sequence: 4 givenname: Jia surname: Li fullname: Li, Jia organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 5 givenname: Avni M. surname: Desai fullname: Desai, Avni M. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 6 givenname: Sree B. surname: Chalasani fullname: Chalasani, Sree B. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 7 givenname: Elizabeth surname: Won fullname: Won, Elizabeth organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 8 givenname: David P. surname: Kelsen fullname: Kelsen, David P. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 9 givenname: David H. surname: Ilson fullname: Ilson, David H. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 10 givenname: Yelena Y. surname: Janjigian fullname: Janjigian, Yelena Y. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center – sequence: 11 givenname: Marinela surname: Capanu fullname: Capanu, Marinela organization: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center – sequence: 12 givenname: Geoffrey Y. orcidid: 0000-0002-0448-1038 surname: Ku fullname: Ku, Geoffrey Y. email: kug@mskcc.org organization: Department of Medicine, Memorial Sloan Kettering Cancer Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35066693$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021. |
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| Keywords | VEGFR2 PDGFR Ramucirumab Crenolanib Gastric cancer Esophageal cancer |
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Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest.... Paclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest. One... PurposePaclitaxel plus ramucirumab is a standard second-line regimen for patients with advanced gastric adenocarcinoma, but clinical benefit remains modest.... |
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