Search Results - "Bulat, Iurie"

The pharmacokinetics of pamiparib in the presence of a strong CYP3A inhibitor (itraconazole) and strong CYP3A inducer (rifampin) in patients with solid tumors: an open-label, parallel-group phase 1 study by Mu, Song, Lin, Chester, Skrzypczyk-Ostaszewicz, Anna, Bulat, Iurie, Maglakelidze, Marina, Skarbova, Viera, Andreu-Vieyra, Claudia, Sahasranaman, Srikumar

“…Purpose Pamiparib is an investigational, selective, oral poly(ADP-ribose) polymerase 1/2 (PARP1/2) inhibitor that has demonstrated PARP–DNA complex trapping…”
Get full text

Pharmacokinetic Drug–Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer by Duran, Ignacio, Carles, Joan, Bulat, Iurie, Hellemans, Peter, Mitselos, Anna, Ward, Peter, Jiao, James, Armas, Danielle, Chien, Caly

“…Background and Objectives Two phase I studies assessed the drug–drug interaction potential of apalutamide as a substrate and perpetrator. Methods Study A…”
Get full text

Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study by O'Malley, David M, Neffa, Maryna, Monk, Bradley J, Melkadze, Tamar, Huang, Marilyn, Kryzhanivska, Anna, Bulat, Iurie, Meniawy, Tarek M, Bagameri, Andrea, Wang, Edward W, Doger de Speville Uribe, Bernard, Hegg, Roberto, Ortuzar Feliu, Waldo, Ancukiewicz, Marek, Lugowska, Iwona

“…Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising…”
Get full text

Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study by Siefker-Radtke, Arlene O, Necchi, Andrea, Park, Se Hoon, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle F, Fleming, Mark T, Rezazadeh Kalebasty, Arash, Mellado, Begoña, Varlamov, Sergei, Joshi, Monika, Duran, Ignacio, Tagawa, Scott T, Zakharia, Yousef, Akapame, Sydney, Santiago-Walker, Ademi E, Monga, Manish, O'Hagan, Anne, Loriot, Yohann, Necchi, Andrea, Loriot, Yohann, Park, Se Hoon, Tagawa, Scott, Flechon, Aude, Alexeev, Boris, Varlamov, Sergey, Huddart, Robert, Vano, Yann, Gasparro, Donatello, Hamzaj, Alketa, Kopyltsov, Eugeniy, Gracia Donas, Jesus, Mellado, Begona, Parikh, Omi, Schatteman, Peter, Culine, Stephane, Houédé, Nadine, Zanetta, Sylvie, Facchini, Gaetano, Scagliotti, Giorgio, Schinzari, Giovanni, Lee, Jae Lyun, Shkolnik, Mikhail, Fleming, Mark, Joshi, Monica, O'Donnell, Peter, Stöger, Herbert, Decaestecker, Karel, Dirix, Luc, Machiels, Jean Pascal, Borchiellini, Dephine, Delva, Remy, Rolland, Frederic, Hadaschik, Boris, Retz, Margitta, Rosenbaum, Eli, Basso, Umberto, Mosca, Alessandra, Shin, Dong Bok, Cebotaru, Cristina, Duran, Ignacio, Moreno, Victor, Perez Gracia, Jose Luis, Pinto, Alvaro, Su, Wen-Pin, Wang, Shian-Shiang, Schnadig, Ian, Srinivas, Sandhya, Vogelzang, Nicholas, Loidl, Wolfgang, Meran, Johannes, Gross Goupil, Marine, Joly, Florence, Imkamp, Florian, Krege, Susanne, May, Matthias, Schultze-Seemann, Wolfgang, Strauss, Arne, Zimmermann, Uwe, Keizman, Daniel, Peer, Avivit, Sella, Avishai, Berardi, Rossana, De Giorgi, Ugo, Sternberg, Cora Nanette, Rha, Sun Young, Bulat, Iurie, Izmailov, Adel, Matveev, Vsevolod, Vladimirov, Vladimir, Carles, Joan, Font, Albert, Saez, Maribel, Syndikus, Isabel, Tarver, Kathryn, Appleman, Leonard, Burke, John, Dawson, Nancy, Jain, Sharad, Zakharia, Yousef

“…Erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, was shown to be clinically active and tolerable in patients with…”
Get full text

HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma— Overall survival analysis by Maglakelidze, Marina, Ryspayeva, Dinara E., Andric, Zoran, Petrovic, Zoran, Bulat, Iurie, Nikolic, Ivan, Nagarkar, Rajnish, Wiedermann, Ursula, Blumenstein, Brent A., Chong, Leslie Mi Ok, Ede, Nicholas, Nixon, Bonnie, Yavrom, Sharon, Selvaggi, Giovanni, Good, Anthony J., Chawla, Tanuj

“…289 Background: Active immunization with the B-lymphocyte stimulating HER2 vaccine, HER-Vaxx (IMU-131), has shown clinical response correlated with…”
Get full text

Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON) by Tobias, Joshua, Maglakelidze, Marina, Andrić, Zoran, Ryspayeva, Dinara, Bulat, Iurie, Nikolić, Ivan, Petrović, Zoran, Chawla, Tanuj, Nagarkar, Rajnish, Garner-Spitzer, Erika, Zielinski, Christoph C, Chong, Leslie Mi Ok, Nixon, Bonnie, Ede, Nicholas J, Yavrom, Sharon, Kundi, Michael, Wiedermann, Ursula

“…A multicenter, randomized, open-label, phase II study (HERIZON; NCT02795988) was conducted to evaluate the clinical and immunologic efficacy of HER-Vaxx…”
Get full text

Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer-Results from Phase Ib Trial IMU.ACS.001 by Wiedermann, Ursula, Garner-Spitzer, Erika, Chao, Yee, Maglakelidze, Marina, Bulat, Iurie, Dechaphunkul, Arunee, Arpornwirat, Wichit, Charoentum, Chaiyut, Yen, Chia-Jui, Yau, Thomas Cheung, Tanasanvimon, Suebpong, Maneechavakajorn, Jedzada, Sookprasert, Aumkhae, Bai, Li-Yuan, Chou, Wen-Chi, Ungtrakul, Teerapat, Drinic, Mirjana, Tobias, Joshua, Zielinski, Christoph C, Chong, Leslie, Ede, Nicholas J, Marino, Mark T, Good, Anthony J

“…HER2/neu is overexpressed in up to 30% of gastroesophageal adenocarcinomas (GEA) and linked to poor prognosis. Recombinant mAbs to treat…”
Get full text

Abstract CT107: A PHASE 1B/2 OPEN-LABEL STUDY WITH RANDOMIZATION IN PHASE 2 OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION by Maglakelidze, Marina, Ryspayeva, Dinara, Bulat, Iurie, Andric, Zoran, Nikolic, Ivan, Chawla, Tanuj, Nagarkar, Rajnish, Chourdhary, Vaibhav, Venkata, Giri, Singh, Rajesh Kumar, Radosavljevic, Davorin, Petrovic, Zoran, Wiedermann, Ursula, Chong, Leslie, Ede, Nicholas J., Laeufle, Rita, Good, Anthony

“…Abstract Background: HER2/neu is overexpressed in up to 30% of gastroesophageal adenocarcinoma (GEA) patients and associated with poor prognosis. Recombinant…”
Get full text

HERIZON: A phase 1B/2 open-label study of imu-131 HER2/neu peptide vaccine PLUS standard of care chemotherapy with randomization in phase 2 in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction by Laeufle, Rita, Maglakelidze, Marina, Bulat, Iurie, Ryspayeva, Dinara, Zoran, Andric, Chawla, Tanuj, Nikolic, Ivan, Nagarkar, Rajnish, Venkata, Giri, Choudhary, Vaibhav, Radosavljevic, Davorin, Singh, Rajesh Kumar, Wiedermann, Ursula, Good, Anthony J, Ede, Nick, Chong, Leslie Mi Ok

“…Abstract only e16065 Background: The phase 2 part of the study hypothesizes HER-Vaxx (IMU-131) will provide treatment benefits consistent with traditional…”
Get full text

Safety and activity of anti-mesothelin antibody-drug conjugate anetumab ravtansine in combination with pegylated-liposomal doxorubicin in platinum-resistant ovarian cancer: multicenter, phase Ib dose escalation and expansion study by Santin, Alessandro D, Vergote, Ignace, González-Martín, Antonio, Moore, Kathleen, Oaknin, Ana, Romero, Ignacio, Diab, Sami, Copeland, Larry J, Monk, Bradley J, Coleman, Robert L, Herzog, Thomas J, Siegel, Jonathan, Kasten, Linda, Schlicker, Andreas, Schulz, Anke, Köchert, Karl, Walter, Annette O, Childs, Barrett H, Elbi, Cem, Bulat, Iurie

“…Anetumab ravtansine is an antibody-drug conjugate consisting of a fully human anti-mesothelin monoclonal antibody conjugated to cytotoxic maytansinoid tubulin…”
Get more information

Abstract P1-19-17: Dose escalation and expansion study of lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed with no drug holiday in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer by Bulat, Iurie, Maglakelidze, Marina, Murias, Carmen, Krastev, Boris, Baird, Richard D, Wardley, Andrew M, Roylance, Rebecca, Crijanovschi, Adrian, Gogiladze, Maia, Pritchett, Yili, McCullough, Amy, Li, Chao, Sorrentino, Jessica A, Malik, Rajesh, Beelen, Andrew P

“…Abstract Approved CDK4/6 inhibitors have demonstrated significant improvements in progression free survival when combined with fulvestrant in patients with…”
Get full text

Rintodestrant (G1T48), an oral selective estrogen receptor degrader, in combination with palbociclib for ER+/HER2– advanced breast cancer: Phase 1 results by Maglakelidze, Marina, Bulat, Iurie, Ryspayeva, Dinara, Krastev, Boris Milev, Gogiladze, Maia, Crijanovschi, Adrian, Aftimos, Philippe Georges, Neven, Patrick, Pegram, Mark D., Menke, Catharina Wilhelmina, Dees, Elizabeth Claire, Schroder, Carolien P., Jager, A., Chap, Linnea I., Hamilton, Erika P., Cristofanilli, Massimo, Ulahannan, Susanna Varkey, Boers, Jorianne, Iqbal, Ramsha, Jain, Sarika

“…Abstract only 1063 Background: Rintodestrant, a potent, oral selective estrogen receptor degrader, competitively binds and degrades the estrogen receptor (ER),…”
Get full text

Phase 2 study of PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected subjects with metastatic NSCLC after one prior platinum-containing regimen (SELECT) by Kobziev, Oleh, Bulat, Iurie, Ostapenko, Yuriy, Zvirbule, Zanete, Ursol, Grygorii, Boyko, Vasyl, Paramonov, Viktor, Hashambhoy-Ramsay, Yasmin, Hart, Courtney, Harvey, Christopher, Graca, Ashley, Le, Lidya, Zhang, Weidong, Chao, Bo, Jimenez, Judy, Bala, Krithi, Maxwell, Sarah, Laken, Haley, Baeck, Johan, Hooper, Ellen Michelle Diament

“…Abstract only TPS9137 Background: Immune checkpoint inhibitors have led to durable remissions for some patients with advanced malignancies, including NSCLC;…”
Get full text

Abstract PS12-04: Rintodestrant (G1T48), an oral selective estrogen receptor degrader in ER+/HER2- locally advanced or metastatic breast cancer: Updated phase 1 results and dose selection by Aftimos, Philippe, Neven, Patrick, Pegram, Mark, van Oordt, Catharina Willemien Menke-van der Houven, Dees, E. Claire, Schröder, Carolien, Jager, Agnes, Bulat, Iurie, Chap, Linnea, Maglakelidze, Marina, Hamilton, Erika, Cristofanilli, Massimo, Ulahannan, Susanna, Boers, Jorianne, Iqbal, Ramsha, Crijanovschi, Adrian, Wolfgang, Curt D, Tao, Wenli, Sipes, Christina, Malik, Rajesh, Jain, Sarika

“…Abstract Background: Rintodestrant (G1T48) is a potent oral selective estrogen receptor degrader (SERD) that competitively binds to the estrogen receptor (ER)…”
Get full text

Abstract PD8-07: Pharmacodynamic analysis from a phase 1 study of rintodestrant (G1T48), an oral selective estrogen receptor degrader, in ER+/HER2- locally advanced or metastatic breast cancer by Aftimos, Philippe, Maglakelidze, Marina, Glaudemans, Andor WJM, Hamilton, Erika, Chap, Linnea, de Vries, Elisabeth, Menke-van der Houven van Oordt, Catharina Willemien, Jager, Agnes, Dees, E. Claire, Cristofanilli, Massimo, Pegram, Mark, Ulahannan, Susanna, Neven, Patrick, Bulat, Iurie, Rai, Ruhi, Tao, Wenli, Jain, Sarika, Beelen, Andrew P, Sorrentino, Jessica A

“…Abstract Background: Rintodestrant is an orally bioavailable, potent and selective estrogen receptor degrader (SERD) that inhibits estrogen receptor (ER) gene…”
Get full text

Phase Ib study of anti-mesothelin antibody drug conjugate anetumab ravtansine in combination with pegylated liposomal doxorubicin in platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer by Bulat, Iurie, Moore, Kathleen N., Haceatrean, Alexei, Chung, John Woojune, Rajagopalan, Prabhu, Xia, Chenghua, Laurent, Dirk, Childs, Barrett H., Santin, Alessandro

“…Abstract only…”
Get full text

A phase Ib study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction by Chao, Yee, Yau, Thomas, Maglakelidze, Marina, Bulat, Iurie, Tanasanvimon, Suebpong, Charoentum, Chaiyut, Arpornwirat, Wichit, Maneechavakajorn, Jedzada, Dechaphunkul, Arunee, Ungtrakul, Teerapat, Yen, Chia-Jui, Bai, Li-Yuan, Chou, Wen-Chi, Wiedermann, Ursula, Good, Anthony J, Ede, Nick, Chong, Leslie Mi Ok

“…Abstract only 4030 Background: Gastric cancer is the 5th most common cancer and the 3rd leading cause of cancer deaths. HER2/neu is overexpressed in 15% - 25%…”
Get full text

An open-label, multicenter, phase Ib study investigating the effect of apalutamide on ventricular repolarization in men with castration-resistant prostate cancer by Belderbos, Bodine P. S. I., de Wit, Ronald, Chien, Caly, Mitselos, Anna, Hellemans, Peter, Jiao, James, Yu, Margaret K., Attard, Gerhardt, Bulat, Iurie, Edenfield, W. Jeffrey, Saad, Fred

“…Purpose Phase Ib study evaluating the effect of apalutamide, at therapeutic exposure, on ventricular repolarization by applying time-matched pharmacokinetics…”
Get full text

G1T38, an oral CDK4/6 inhibitor, dosed continuously in combination with fulvestrant for HR+ breast cancer: Preliminary phase 1b results by Bulat, Iurie, Maglakelidze, Marina, Murias, Carmen, Kurteva, Galina Petrova, Roylance, Rebecca, Gogiladze, Maia, Crijanovschi, Adrian, McCullough, Amy, Shearin, Elizabeth, Sorrentino, Jessica, Sipes, Christina, Yang, Zhao, Cai, Yaping, Malik, Rajesh K., Beelen, Andrew Paul

“…Abstract only…”
Get full text

Abstract CT059: A Phase Ib open label multicenter study with a HER2/neu peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy shows safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced cancer of the stomach by Wiedermann, Ursula, Garner-Spitzer, Erika, Chao, Yee, Bulat, Iurie, Dechaphunkul, Arunee, Arpornwirat, Wichit, Charoentum, Chaiyut, Yen, Chia-Jui, Yau, Thomas Cheung, Maglakelidze, Marina, Tanasanvimon, Suebpong, Maneechavakajorn, Jedzada, Sookprasert, Aumkhae, Bai, Li-Yuan, Chou, Wen-Chi, Ungtrakul, Teerapat, Zielinski, Christoph C., Chong, Leslie, Ede, Nick, Good, Anthony J

“…Abstract Background: HER2/neu is overexpressed in 15-25% of gastric cancer patients and associated with poor prognosis. Alternative treatments to monoclonal…”
Get full text