A framework for assessing the impact of accelerated approval von Gould, A Lawrence, Campbell, Robert K, Loewy, John W, Beckman, Robert A, Dey, Jyotirmoy, Schiel, Anja, Burman, Carl-Fredrik, Zhou, Joey, Antonijevic, Zoran, Miller, Eva R, Tang, Rui

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Results of an International Randomized Phase III Trial of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus Versus Placebo to Control Metastatic Sarcomas in Patients After... von DEMETRI, George D, CHAWLA, Sant P, REICHARDT, Peter, BOMPAS, Emmanuelle, ALCINDOR, Thierry, RUSHING, Daniel, YANG SONG, LEE, Ruey-Min, EBBINGHAUS, Scot, EID, Joseph E, LOEWY, John W, HALUSKA, Frank G, RAY-COQUARD, Isabelle, DODION, Pierre F, BLAY, Jean-Yves, LE CESNE, Axel, STADDON, Arthur P, MILHEM, Mohammed M, PENEL, Nicolas, RIEDEL, Richard F, BUI-NGUYEN, Binh, CRANMER, Lee D

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Phase II Study of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus in Patients With Advanced Bone and Soft Tissue Sarcomas von CHAWLA, Sant P, STADDON, Arthur P, RIVERA, Victor M, CLACKSON, Tim, LOEWY, John W, HALUSKA, Frank G, DEMETRI, George D, BAKER, Laurence H, SCHUETZE, Scott M, TOLCHER, Anthony W, D'AMATO, Gina Z, BLAY, Jean-Yves, MITA, Monica M, SANKHALA, Kamalesh K, BERK, Lori

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Efficacy and Tolerability of Long-Acting Injectable Naltrexone for Alcohol Dependence: A Randomized Controlled Trial von Garbutt, James C, Kranzler, Henry R, O’Malley, Stephanie S, Gastfriend, David R, Pettinati, Helen M, Silverman, Bernard L, Loewy, John W, Ehrich, Elliot W, Vivitrex Study Group, for the

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A Phase I Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Deforolimus in Patients with Advanced Malignancies von HARTFORD, Christine M, DESAI, Apurva A, BEDROSIAN, Camille, RATAIN, Mark J, JANISCH, Linda, KARRISON, Theodore, RIVERA, Victor M, BERK, Lori, LOEWY, John W, KINDLER, Hedy, STADLER, Walter M, KNOWLES, Heather L

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Ethical Considerations in Adaptive Design Clinical Trials von Laage, Thomas, Loewy, John W., Menon, Sandeep, Miller, Eva R., Pulkstenis, Erik, Kan-Dobrosky, Natalia, Coffey, Christopher

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Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease von Sands, Bruce E., Bank ‡, Simmy, Sninsky §, Charles A., Robinson ∥, Malcolm, Katz ¶, Seymour, Singleton #, John W., Miner, Philip B., Safdi, Michael A., Galandiuk ‡‡, Susan, Hanauer §§, Stephen B., Varilek ∥∥, Gary W., Buchman ¶¶, Alan L., Rodgers ##, Vance D., Salzberg, Bruce, Cai ‡‡, Bin, Loewy ‡‡‡, John, DeBruin ‡‡‡, Michael F., Rogge ‡‡‡, Holly, Shapiro ‡‡‡, Mark, Schwertschlag ‡‡‡, Ullrich S.

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Combined immunotherapy with controlled interleukin-12 gene therapy and immune checkpoint blockade in recurrent glioblastoma: An open-label, multi-institutional phase I trial von Chiocca, E Antonio, Gelb, Arnold B, Chen, Clark C, Rao, Ganesh, Reardon, David A, Wen, Patrick Y, Bi, Wenya Linda, Peruzzi, Pierpaolo, Amidei, Christina, Triggs, Dan, Seften, Leah, Park, Grace, Grant, James, Truman, Kyla, Buck, Jill Y, Hadar, Nira, Demars, Nathan, Miao, John, Estupinan, Taylor, Loewy, John, Chadha, Kamal, Tringali, Joseph, Cooper, Laurence, Lukas, Rimas V

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Survival of subjects with recurrent glioblastoma receiving intratumoral administration of controlled IL-12 with limited exposure to dexamethasone von Lukas, Rimas Vincas, Kurz, Sylvia Christine, Yu, John, Landolfi, Joseph C., Rao, Ganesh, Amidei, Christina, Buck, Jill Yannetti, Hadar, Nira, Estupinan, Taylor, Miao, John, Loewy, John W., Wang, Yunxia, Demars, Nathan A., Gelb, Arnold Bruce, Cooper, Laurence JN

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Final results of controlled IL-12 monotherapy in adults with grade III or IV gliomas von Chiocca, E. Antonio, Lukas, Rimas Vincas, Yu, John, Yamini, Bakhtiar, Oberheim Bush, Nancy Ann, Amidei, Christina, Buck, Jill Yannetti, Demars, Nathan A., Hadar, Nira, Miao, John, Estupinan, Taylor, Wang, Yunxia, Loewy, John W., Gelb, Arnold Bruce, Cooper, Laurence JN

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CTIM-20. FINAL RESULTS OF CONTROLLED IL-12 MONOTHERAPY AND IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA von Lukas, Rimas, Oberheim-Bush, Nancy Ann, Cavaliere, Robert, Landolfi, Joseph, Yu, John S, Chen, Clark, Cordova, Christine, Amidei, Christina, Buck, Jill Y, Hadar, Nira, Demars, Nate, Miao, John, Loewy, John, Estupinan, Taylor, Chadha, Kamal, Cooper, Laurence J N, Chiocca, E Antonio

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Controlled IL-12 in combination with a PD-1 inhibitor subjects with recurrent glioblastoma von Chiocca, E. Antonio, Lukas, Rimas Vincas, Chen, Clark C, Rao, Ganesh, Amidei, Christina, Buck, Jill Yannetti, Hadar, Nira, Demars, Nathan A., Miao, John, Estupinan, Taylor, Loewy, John W., Wang, Yunxia, Gelb, Arnold Bruce, Cooper, Laurence JN

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Novel adaptive designs: aligning drug development and patient incentives von Loewy, John W

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CTIM-28. PHASE 2 TRIAL OF CONTROLLED IL-12 IN COMBINATION WITH PD-1 INHIBITOR IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (rGBM) von Lukas, Rimas, Chiocca, E Antonio, Bush, Nancy Ann Oberheim, Landolfi, Joseph, Cavaliere, Robert, Yu, John, Kurz, Sylvia, Demars, Nathan, Buck, Jill, Hadar, Nira, Miao, John, Loewy, John, Wang, Yunxia, Gelb, Arnold, Cooper, Laurence

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CTIM-05. COMBINATION OF CONTROLLED INTERLEUKIN-12 GENE THERAPY WITH IMMUNE CHECKPOINT BLOCKADE IN RECURRENT GLIOBLASTOMA: UPDATED RESULTS OF A MULTI-INSTITUTIONAL, OPEN LABEL PHASE... von Antonio Chiocca, E, Lukas, Rimas, Chen, Clark, Rao, Ganesh, Amidei, Christina, Buck, Jill, Hadar, Nira, Demars, Nathan, Miao, John, Estupinan, Taylor, Loewy, John, Wang, Yunxia, Gelb, Arnold, Cooper, Laurence

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Upper Extremity Physical Factors Affecting Tennis Serve Velocity von Cohen, David B., Mont, Michael A., Campbell, Kevin R., Vogelstein, Barry N., Loewy, John W.

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Reconsideration of pacemakers and MR imaging von Loewy, John, Loewy, Amanda, Kendall, Edward J

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Safety and Preliminary Efficacy Analysis of the mTOR Inhibitor Ridaforolimus in Patients With Taxane-Treated, Castration-Resistant Prostate Cancer von Amato, Robert J, Wilding, George, Bubley, Glenn, Loewy, John, Haluska, Frank, Gross, Mitchell E

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Transient thalamic changes on MRI in a child with hypernatremia von Hartfield, Dawn S, Loewy, John A, Yager, Jerome Y

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A Randomized Placebo-Controlled Trial of Recombinant Human Interleukin-11 in Cancer Patients With Severe Thrombocytopenia Due To Chemotherapy von Tepler, Isidore, Elias, Laurence, Smith, John W., Hussein, Mohamad, Rosen, Gerald, Chang, Alex Y.-C., Moore, Joseph O., Gordon, Michael S., Kuca, Bernice, Beach, Kathleen J., Loewy, John W., Garnick, Marc B., Kaye, James A.

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