The Experts below are selected from a list of 15 Experts worldwide ranked by ideXlab platform
L-t Chen - One of the best experts on this subject based on the ideXlab platform.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British Journal of Cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:Background: PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods: Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m^−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS_3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS_3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion: PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British journal of cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
M A Tempero - One of the best experts on this subject based on the ideXlab platform.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British Journal of Cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:Background: PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods: Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m^−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS_3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS_3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion: PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British journal of cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
Y-l Lin - One of the best experts on this subject based on the ideXlab platform.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British Journal of Cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:Background: PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods: Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m^−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS_3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS_3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion: PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British journal of cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
C G Yeh - One of the best experts on this subject based on the ideXlab platform.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British Journal of Cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:Background: PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods: Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m^−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS_3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS_3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion: PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British journal of cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
Y-w Wang - One of the best experts on this subject based on the ideXlab platform.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British Journal of Cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:Background: PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Methods: Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m^−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS_3-month). Results: A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS_3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. Conclusion: PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
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A multinational phase 2 study of nanoliposomal irinotecan Sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer
British journal of cancer, 2013Co-Authors: M A Tempero, Y-s Shan, Y-l Lin, E Dito, A Ong, Y-w Wang, C G Yeh, L-t ChenAbstract:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer. Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month). A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.
