[Translation] A multicenter, prospective, non-interventional study of the safety and efficacy of sunitinib in patients with well-differentiated pancreatic neuroendocrine tumors

舒尼替尼的非干预性研究其目的是对于晚期或转移性高分化胰腺神经内分泌瘤的中国患者中系统性地收集数据，并评估治疗的安全性和有效性。主要目标是评价舒尼替尼在治疗进行性、不可切除的晚期或转移性高分化胰腺神经内分泌瘤的中国患者时的安全性情况。次要目标是评价无进展生存期（PFS）、总生存期（OS）和5年生存率。

[Translation]

The purpose of the non-interventional study of sunitinib is to systematically collect data and evaluate the safety and efficacy of treatment in Chinese patients with advanced or metastatic well-differentiated pancreatic neuroendocrine tumors. The primary objective is to evaluate the safety of sunitinib in the treatment of Chinese patients with progressive, unresectable advanced or metastatic well-differentiated pancreatic neuroendocrine tumors. Secondary objectives are to evaluate progression-free survival (PFS), overall survival (OS) and 5-year survival rate.

Start Date12 Dec 2014

Sponsor / Collaborator

Pfizer Italia Srl

[+2]

CTR20140783 / CompletedPhase 4

一项苹果酸舒尼替尼在晚期胰腺内分泌瘤患者中的疗效和安全性的单组、开放标签、国际、多中心研究

[Translation] A single-group, open-label, international, multicenter study of the efficacy and safety of sunitinib malate in patients with advanced pancreatic endocrine tumors

这项研究的目的是确认在患有不可切除的胰腺神经内分泌肿瘤的受试者中进行的、舒尼替尼关键3期研究的安全性和疗效结果。进行这项研究旨在遵守上市后监管承诺。

[Translation]

The purpose of this study is to confirm the safety and efficacy results of the pivotal Phase 3 study of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors. This study was conducted to comply with post-marketing regulatory commitments.

Start Date28 Aug 2014

Sponsor / Collaborator

Pfizer Italia Srl

[+2]

CTR20132931 / CompletedPhase 4

中国早期浸润性乳腺癌患者接受阿诺新辅助治疗后的前瞻性非干预性研究

[Translation] A prospective non-interventional study of neoadjuvant therapy with Arnold for Chinese patients with early invasive breast cancer

获得阿诺新辅助治疗中国早期浸润性乳腺癌患者的有效性和安全性数据。主要目的：观察阿诺新治疗经他莫昔芬辅助治疗2～3 年后，绝经后雌激素受体阳性早期浸润性乳腺癌妇女的疗效；次要目的：观察阿诺新治疗经他莫昔芬辅助治疗2～3 年后，绝经后雌激素受体阳性早期浸润性乳腺癌妇女的安全性。

[Translation]

To obtain the efficacy and safety data of Arnoxin in the adjuvant treatment of early invasive breast cancer in China. Primary purpose: To observe the efficacy of Arnoxin in the treatment of postmenopausal women with estrogen receptor-positive early invasive breast cancer after 2-3 years of adjuvant tamoxifen treatment; Secondary purpose: To observe the safety of Arnoxin in the treatment of postmenopausal women with estrogen receptor-positive early invasive breast cancer after 2-3 years of adjuvant tamoxifen treatment.

Start Date09 Feb 2011

Sponsor / Collaborator

Pfizer Investment Co. Ltd.

[+1]

100 Clinical Results associated with Pfizer Italia Srl

0 Patents (Medical) associated with Pfizer Italia Srl

Literatures (Medical) associated with Pfizer Italia Srl

02 May 2024·Cancer Research

Abstract PO2-20-04: TACTIVE-U: phase 1b/2 umbrella study of vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, combined with other anticancer treatments in ER–positive advanced or metastatic breast cancer

Author: Layman, Rachel ; Isaacs, Claudine ; Anderson, Sibyl ; Jerzak, Katarzyna ; Ma, Cynthia ; Valota, Olga ; Lu, Dongrui ; Mo, Gary ; Guimarães, José Luiz Miranda ; Hilton, John ; Calella, Anna Maria

AbstractBackground: Vepdegestrant (ARV-471), an oral PROTAC ER degrader, was well tolerated and showed evidence of clinical activity in the first-in-human phase 1/2 study in heavily pretreated patients with ER+/human epidermal growth factor receptor 2–negative (HER2-) advanced breast cancer (NCT04072952). The cyclin-dependent kinase (CDK)4/6 inhibitors abemaciclib and ribociclib are approved in combination with an aromatase inhibitor or fulvestrant, or as monotherapy (abemaciclib), for ER+/HER2- advanced or metastatic breast cancer. In preclinical studies, vepdegestrant combined with abemaciclib or ribociclib showed evidence of synergistic interactions in ER+ breast cancer cells and greater tumor growth inhibition in a xenograft breast cancer model compared with fulvestrant in combination with these agents. Inhibitors targeting different CDKs, such as samuraciclib (oral CDK7 inhibitor), are in clinical development for solid tumors. The open-label, phase 1b/2 TACTIVE-U umbrella study will evaluate the safety, efficacy, and pharmacokinetics of vepdegestrant in combination with other anticancer treatments in patients with ER+ advanced or metastatic breast cancer. Vepdegestrant is being evaluated in combination with abemaciclib (sub-study A; NCT05548127), ribociclib (sub-study B; NCT05573555), and samuraciclib (sub-study C).Trial Design: Patients eligible for current sub-studies of TACTIVE-U are aged ≥18 years, have histologically or cytologically confirmed ER+/HER2- advanced or metastatic breast cancer not amenable to surgical resection, and have received prior therapy for advanced or metastatic disease, including any CDK4/6 inhibitor–based regimen in any setting. In each sub-study, patients will receive vepdegestrant orally once daily (QD) continuously in a dose escalation/de-escalation approach. Abemaciclib will be given orally twice daily continuously in sub-study A, ribociclib will be given orally QD for 21 days followed by 7 days off treatment in sub-study B, and samuraciclib will be given orally QD continuously in sub-study C. For all sub-studies, the primary endpoint of the phase 1b portion is dose-limiting toxicities to determine the recommended phase 2 dose of vepdegestrant in combination with the other anticancer treatment. Secondary endpoints of phase 1b are antitumor activity (objective response, clinical benefit rate [CBR], and duration of response [DOR]), progression-free survival (PFS), safety (type, frequency, and severity of adverse events and laboratory abnormalities), and plasma concentrations of study drugs. The phase 2 portion of each sub-study will further evaluate the antitumor activity of the combinations; the primary endpoint is objective response and secondary endpoints include antitumor activity (CBR and DOR), PFS, overall survival, safety, plasma concentration of study drugs, and changes in circulating tumor DNA. Future combination sub-studies will be included in TACTIVE-U.Citation Format: Claudine Isaacs, Katarzyna Jerzak, John Hilton, José Luiz Miranda Guimarães, Rachel Layman, Dongrui Lu, Gary Mo, Anna Maria Calella, Olga Valota, Sibyl Anderson, Cynthia Ma. TACTIVE-U: phase 1b/2 umbrella study of vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, combined with other anticancer treatments in ER–positive advanced or metastatic breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-20-04.

01 Mar 2004·XenobioticaQ4 · MEDICINE

Prediction of whole-body metabolic clearance of drugs through the combined use of slices from rat liver, lung, kidney, small intestine and colon

Q4 · MEDICINE

Article

Author: De Jager, M. H. ; Groothuis, G. M. M. ; Monshouwer, M. ; Draaisma, A. L. ; De Kanter, R. ; Meijer, D. K. F. ; De Graaf, I. A. M. ; Proost, J. H.

1: The aim was to investigate whether precision-cut rat tissue slices could be used to predict metabolic drug clearance in vivo. To obtain a complete picture, slices not only from liver, but also from lung, kidney, small intestine and colon were included. 2: The metabolic clearances of 7-ethoxycoumarin, 7-hydroxycoumarin, testosterone, methyltestosterone and warfarin were determined by measuring the disappearance of these compounds during incubation with slices prepared from liver, lung, kidney, small intestine and colon. 3: The total in vitro metabolic clearance was determined by adding the individual in vitro organ clearances from the slices. Prediction based on the in vitro clearance was within an order of magnitude to the corresponding in vivo values. Interestingly, the relative contribution of extrahepatic metabolic clearance of the studied compounds to total clearance was remarkably high, ranging from 35 to 72% of the total metabolic clearance. 4: It is concluded that the model of multi-organ precision-cut slices is a useful in vitro tool for prediction of in vivo metabolic clearance. In addition, it provides information about the relative contribution of the liver, lung, kidney, small intestine and colon to the total metabolic clearance.

01 Mar 2003·PharmacoEconomics Italian Research Articles

Cost-analysis of a 6-week cycle of therapy with celecoxib vs conventional NSAIDs in ostheoarthritis in Italy

Author: D. Roggeri ; S. Chiroli ; G. Annoni ; Carlo Lucioni

To estimate the cost in the Italian National Health Service (INHS) perspective of a 6-week treatment course with celecoxib vs NSAIDs in ostheoarthritis patients. A decision-tree analysis with a 6-week time-frame. Costs included the acquisition cost of celecoxib 200 mg/day and of a basket of the first ten prescribed NSAIDs in Italy during the year 2000. Probabilities of side effects were derived from clinical trials comparing celecoxib vs NSAIDs and adjusted for 6-week exposure. Costs to treat the adverse events and probability of hospitalization were derived from a previous study conducted in Italy among GPs. Sensitivity and treshold analyses were conducted to test the robustness of the model. In the 6-week period, celecoxib resulted the less expensive strategy vs NSAIDs (€ 72,35 vs 78,63). Probability of serious events with NSAIDs was most critical for the results and the cost-effectiveness of the new therapy was correlated to the risk of serious events with NSAIDs. According to our study results, celecoxib represents a cost-effective first-line strategy alternative to NSAIDs for the symptomatic therapy of ostheoarthritis in Italy.

100 Deals associated with Pfizer Italia Srl

100 Translational Medicine associated with Pfizer Italia Srl

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