Search Results - "Zhong, Bob"

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma by Loriot, Yohann, Necchi, Andrea, Park, Se Hoon, Garcia-Donas, Jesus, Huddart, Robert, Burgess, Earle, Fleming, Mark, Rezazadeh, Arash, Mellado, Begoña, Varlamov, Sergey, Joshi, Monika, Duran, Ignacio, Tagawa, Scott T, Zakharia, Yousef, Zhong, Bob, Stuyckens, Kim, Santiago-Walker, Ademi, De Porre, Peter, O’Hagan, Anne, Avadhani, Anjali, Siefker-Radtke, Arlene O

“…Erdafitinib, an inhibitor of fibroblast growth factor receptor, was tested in previously treated patients with advanced urothelial cancer with FGFR…”
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Single-arm phase II three-outcome designs with handling of over-running/under-running by Guo, Wenchuan, Hui, Jianan, Zhong, Bob

“…Phase II clinical trials are commonly conducted as pilot studies to evaluate the efficacy and safety of the investigational drug in the targeted patient…”
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Target toxicity design for phase I dose-finding by Wenchuan Guo, Bob Zhong

“…We propose a new two-/three-stage dose-finding design called Target Toxicity (TT) for phase I clinical trials, where we link the decision rules in the…”
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Last observation carry-forward and last observation analysis by Shao, Jun, Zhong, Bob

“…Drop‐out often occurs in clinical trials with multiple visits and drop‐out is often informative in the sense that the population of patients who dropped out is…”
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Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors by Bahleda, Rastislav, Italiano, Antoine, Hierro, Cinta, Mita, Alain, Cervantes, Andres, Chan, Nancy, Awad, Mark, Calvo, Emiliano, Moreno, Victor, Govindan, Ramaswamy, Spira, Alexander, Gonzalez, Martha, Zhong, Bob, Santiago-Walker, Ademi, Poggesi, Italo, Parekh, Trilok, Xie, Hong, Infante, Jeffrey, Tabernero, Josep

“…Here, we report results of the first phase I study of erdafitinib, a potent, oral pan-FGFR inhibitor. Patients age ≥18 years with advanced solid tumors for…”
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Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors by Tabernero, Josep, Bahleda, Rastislav, Dienstmann, Rodrigo, Infante, Jeffrey R, Mita, Alain, Italiano, Antoine, Calvo, Emiliano, Moreno, Victor, Adamo, Barbara, Gazzah, Anas, Zhong, Bob, Platero, Suso J, Smit, Johan W, Stuyckens, Kim, Chatterjee-Kishore, Moitreyee, Rodon, Jordi, Peddareddigari, Vijay, Luo, Feng R, Soria, Jean-Charles

“…JNJ-42756493 is an orally administered pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. This first-in-human study evaluates the safety,…”
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Single-arm phase IIA clinical trials with go/no-go decisions by Zhong, Bob

“…Abstract Phase IIA clinical trials are commonly conducted as pilot studies to evaluate efficacy and safety in selected populations of patients with the disease…”
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Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study by Brana, Irene, Calles, Antonio, LoRusso, Patricia M., Yee, Lorrin K., Puchalski, Thomas A., Seetharam, Shobha, Zhong, Bob, de Boer, Carla J., Tabernero, Josep, Calvo, Emiliano

“…C-C chemokine ligand 2 (CCL2) stimulates tumor growth, metastasis, and angiogenesis. Carlumab, a human IgG 1 κ anti-CCL2 mAb, has shown antitumor activity in…”
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A theory for testing hypotheses under covariate-adaptive randomization by Shao, Jun, Yu, Xinxin, Zhong, Bob

“…The covariate-adaptive randomization method was proposed for clinical trials long ago but little theoretical work has been done for statistical inference…”
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Erdafitinib in high-risk patients (pts) with advanced urothelial carcinoma (UC) by Park, Se Hoon, Loriot, Yohann, Zhong, Bob, Hussain, Syed A., Mahadevia, Parthiv Jasvant, De Porre, Peter, Siefker-Radtke, Arlene O.

“…Abstract only 4543 Background: The pan-FGFR inhibitor erdafitinib exhibited a robust objective response rate (ORR) and tolerability among pts with…”
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FGFR-altered, advanced urothelial carcinoma (UC) and response to chemotherapy prior to receiving erdafitinib by Necchi, Andrea, Siefker-Radtke, Arlene O., Zhong, Bob, Mahadevia, Parthiv Jasvant, Santiago-Walker, Ademi E., De Porre, Peter, Loriot, Yohann

“…Abstract only 4542 Background: FGFR-altered, advanced UC has predominantly a luminal 1 subtype, which is associated with lower response rates to immunotherapy…”
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TESTING THE AGREEMENT OF TWO QUANTITATIVE ASSAYS IN INDIVIDUAL MEANS by Zhong, Bob, Shao, Jun

“…Existing approaches for the statistical evaluation of the agreement of two quantitative assays in terms of individual means are either based on a linear model…”
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One-Sample Proportion Testing Procedures for Hypothesis of Inequality by Zhong, Wayne, Zhong, Bob

“…The primary objective of a phase II single arm clinical trial is to determine whether a new treatment is of sufficient activity for a disease to warrant…”
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TRLS-03. A PHASE 1/2 STUDY ASSESSING SAFETY AND PHARMACOKINETICS OF CEMIPLIMAB IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY SOLID OR CENTRAL-NERVOUS-SYSTEM TUMORS AND SAFETY AND EFFICACY OF CEMIPLIMAB IN COMBINATION WITH RADIOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED DIFFUSE INTRINSIC PONTINE GLIOMA, NEWLY DIAGNOSED HIGH-GRADE GLIOMA, OR RECURRENT HIGH-GRADE GLIOMA by Kline, Cassie, Schoenfeld, Jonathan D, Gajjar, Amar, Tinkle, Christopher, Margol, Ashley, Davidson, Tom, Bendel, Anne, Skrypek, Mary, Kilburn, Lindsay, Packer, Roger, Reddy, Alyssa T, Abdelbaki, Mohamed S, Rubin, Josh, Sayour, Elias, Mitchell, Duane, Chi, Susan, Waanders, Angela J, Elster, Jennifer, Baxter, Patricia, Crotty, Erin, Cohen, Kenneth, Moertel, Christopher, Franson, Andrea T, Whipple, Nicholas S, Bansal, Shikha, Jankovic, Vladimir, Kaul, Manika, Paccaly, Anne, Zhong, Bob, Schmidt, Tamara, Lowy, Israel, Seebach, Frank, Liu, Kevin, Gunasti, Lauren, Morinigo, Denise, Singh, Shefali, Shai, Anny, Phillips, Joanna, Filbin, Mariella, Nazarian, Javad, Catalano, Paul, Prados, Michael, Haas-Kogan, Daphne, Magnan, Heather, Mueller, Sabine

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Efficacy of programmed death 1 (PD-1) and programmed death 1 ligand (PD-L1) inhibitors in patients with FGFR mutations and gene fusions: Results from a data analysis of an ongoing phase 2 study of erdafitinib (JNJ-42756493) in patients (pts) with advanced urothelial cancer (UC) by Siefker-Radtke, Arlene O., Necchi, Andrea, Rosenbaum, Eli, Culine, Stephane, Burgess, Earle Frederick, O'Donnell, Peter H., Tagawa, Scott T., Zakharia, Yousef, OHagan, Anne, Avadhani, Anjali Narayan, Zhong, Bob, Santiago-Walker, Ademi E., Roccia, Tito, Loriot, Yohann

“…Abstract only 450 Background: FGFR3 mutations appear to be enriched in luminal 1 UC, which have low expression of markers associated with an immune response,…”
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PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer by Huddart, Robert A, Siefker-Radtke, Arlene O, Balar, Arjun V, Bilen, Mehmet A, Powles, Thomas, Bamias, Aristotelis, Castellano, Daniel, Khalil, Maged F, Van Der Heijden, Michiel S, Koshkin, Vadim S, Pook, David W, Özgüroğlu, Mustafa, Santiago, Linda, Zhong, Bob, Chien, David, Lin, Wei, Tagliaferri, Mary A, Loriot, Yohann

“…The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1)…”
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Safety and activity of the pan-fibroblast growth factor receptor (FGFR) inhibitor erdafitinib in phase 1 study patients (Pts) with molecularly selected advanced cholangiocarcinoma (CCA) by Soria, Jean-Charles, Strickler, John H., Govindan, Ramaswamy, Chai, Seungjean, Chan, Nancy, Quiroga-Garcia, Vanesa, Bahleda, Rastislav, Hierro, Cinta, Zhong, Bob, Gonzalez, Martha, Santiago-Walker, Ademi E., Parekh, Trilok V., Luo, Feng Roger, Sullivan-Chang, Loretta, Xie, Hong, Tabernero, Josep

“…Abstract only 4074 Background: Erdafitinib (JNJ-42756493) is a potent, oral pan-FGFR tyrosine kinase inhibitor that demonstrated encouraging preliminary…”
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First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt) by Siefker-Radtke, Arlene O., Necchi, Andrea, Park, Se Hoon, GarcÃa-Donas, Jesús, Huddart, Robert A, Burgess, Earle Frederick, Fleming, Mark T., Rezazadeh, Arash, Mellado, Begona, Varlamov, Sergei, Joshi, Monika, Duran, Ignacio, Tagawa, Scott T., OHagan, Anne, Avadhani, Anjali Narayan, Zhong, Bob, De Porre, Peter, Loriot, Yohann

“…Abstract only…”
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Erdafitinib (ERDA; JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRa): Phase 2 continuous versus intermittent dosing by Loriot, Yohann, Necchi, Andrea, Park, Se Hoon, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle Frederick, Fleming, Mark T., Rezazadeh, Arash, Mellado, Begona, Varlamov, Sergei, Joshi, Monika, Duran, Ignacio, OHagan, Anne, Avadhani, Anjali Narayan, Zhong, Bob, Stuyckens, Kim, Dosne, Anne-Gaëlle, Siefker-Radtke, Arlene O.

“…Abstract only 411 Background: Although immune checkpoint inhibitors (ICI) have improved outcomes in some pts with platinum-resistant mUC, many pts (eg, pts…”
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A phase 2 study of JNJ-42756493, a pan-FGFR tyrosine kinase inhibitor, in patients (pts) with metastatic or unresectable urothelial cancer (UC) harboring FGFR gene alterations by Siefker-Radtke, Arlene O., Mellado, Begona, Decaestecker, Karel, Burke, John M., O'Hagan, Anne, Avadhani, Anjali Narayan, Zhong, Bob, Santiago-Walker, Ademi E., De Porre, Peter, Brookman-May, Sabine, García-Donas, Jesús

“…Abstract only…”
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