Comparative Bioavailability of Two Formulations of Biopharmaceutical Classification System (BCS) Class IV Drugs: A Case Study of Lopinavir/Ritonavir

Authors: Saeed, Ahmed M., Schmidt, Jeffery M., Munasinghe, Wijith P., Vallabh, Bhadrish K., Jarvis, Michael F., Morris, John B., Mostafa, Nael M.

Source: In Journal of Pharmaceutical Sciences December 2021 110(12):3963-3968

Phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma

Authors: Costa, Luciano J. ^*, Davies, Faith E., Monohan, Gregory P., Kovacsovics, Tibor, Burwick, Nicholas, Jakubowiak, Andrzej, Kaufman, Jonathan L., Hong, Wan-Jen, Dail, Monique, Salem, Ahmed Hamed, Yang, Xiaoqing, Masud, Abdullah A., Munasinghe, Wijith, Ross, Jeremy A., Bueno, Orlando F., Kumar, Shaji K., Stadtmauer, Edward A.

Source: In Blood Advances 12 October 2021 5(19):3748-3759

Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies

Authors: Gray, Heidi J., Bell-McGuinn, Katherine, Fleming, Gini F., Cristea, Mihaela, Xiong, Hao, Sullivan, Danielle, Luo, Yan, McKee, Mark D., Munasinghe, Wijith, Martin, Lainie P.

Source: In Gynecologic Oncology March 2018 148(3):507-514

Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM

Authors: Moreau, Philippe, Chanan-Khan, Asher, Roberts, Andrew W., Agarwal, Amit B., Facon, Thierry, Kumar, Shaji, Touzeau, Cyrille, Punnoose, Elizabeth A., Cordero, Jaclyn, Munasinghe, Wijith, Jia, Jia, Salem, Ahmed Hamed, Freise, Kevin J., Leverson, Joel D., Enschede, Sari Heitner, Ross, Jeremy A., Maciag, Paulo C., Verdugo, Maria, Harrison, Simon J.

Source: In Blood 30 November 2017 130(22):2392-2400

Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study

Authors: Czito, Brian G, Deming, Dustin A, Jameson, Gayle S, Mulcahy, Mary F, Vaghefi, Houman, Dudley, Matthew W, Holen, Kyle D, DeLuca, Angela, Mittapalli, Rajendar K, Munasinghe, Wijith, He, Lei, Zalcberg, John R, Ngan, Samuel Y, Komarnitsky, Philip, Michael, Michael

Source: In The Lancet Gastroenterology & Hepatology June 2017 2(6):418-426

Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a phase 1b study

Authors: Seymour, John F, Ma, Shuo, Brander, Danielle M, Choi, Michael Y, Barrientos, Jacqueline, Davids, Matthew S, Anderson, Mary Ann, Beaven, Anne W, Rosen, Steven T, Tam, Constantine S, Prine, Betty, Agarwal, Suresh K, Munasinghe, Wijith, Zhu, Ming, Lash, L Leanne, Desai, Monali, Cerri, Elisa, Verdugo, Maria, Kim, Su Young, Humerickhouse, Rod A, Gordon, Gary B, Kipps, Thomas J, Roberts, Andrew W

Source: In The Lancet Oncology February 2017 18(2):230-240

Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial

Authors: Maitland, Michael, Piha-Paul, Sarina, Falchook, Gerald, Kurzrock, Razelle, Nguyen, Ly, Janisch, Linda, Karovic, Sanja, McKee, Mark, Hoening, Elizabeth, Wong, Shekman, Munasinghe, Wijith, Palma, Joann, Donawho, Cherrie, Lian, Guinan, Ansell, Peter, Ratain, Mark, Hong, David

Source: British journal of cancer. 118(8):1042-1050

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100170084402.0x000001&indx=1&recIds=ETOCvdc_100170084402.0x000001

Bayesian Optimal Interval (BOIN) Design in Phase 1 Oncology Dose-Finding Trials: An Industry Experience
Joint statistical meetings

Authors: Munasinghe, Wijith Prasantha

Source: JSM proceedings (CD-ROM edition). 2019:479-4

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCCN606213395&indx=1&recIds=ETOCCN606213395

Clinical Pharmacokinetics and Mass Balance of Veliparib in Combination with Temozolomide in Subjects with Nonhematologic Malignancies

Authors: Nuthalapati, Silpa, Munasinghe, Wijith, Giranda, Vincent, Xiong, Hao

Source: Clinical pharmacokinetics. 57(1):51-58

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100130228358.0x000001&indx=1&recIds=ETOCvdc_100130228358.0x000001

Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma

Authors: Reardon, David A., Lassman, Andrew B., van den Bent, Martin, Kumthekar, Priya, Merrell, Ryan, Scott, Andrew M., Fichtel, Lisa, Sulman, Erik P., Gomez, Erica, Fischer, JuDee, Lee, Ho-Jin, Munasinghe, Wijith, Xiong, Hao, Mandich, Helen, Roberts-Rapp, Lisa, Ansell, Peter, Holen, Kyle D., Gan, Hui K.

Source: Neuro-oncology. 19(7):965-975

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100074717876.0x000001&indx=1&recIds=ETOCvdc_100074717876.0x000001

A First-in-Human Phase 1 Study of ABBV-525, a Small-Molecule MALT1 Inhibitor, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Authors: Sochacki, Andrew L., Burger, Jan A., Ludwig, Carrianne, Assaily, Wissam, Munasinghe, Wijith, Pappano, William, Greenberg, Edward, Will, Christine, Thompson, Meghan C.

Source: In Blood 2 November 2023 142 Supplement 1:3101-3101

MO38-1 Phase 1 study of ABBV-155 ± paclitaxel in relapsed/refractory solid tumors: Results in Japanese patients

Authors: Shimizu, Toshio, Yonemori, Kan, Kuboki, Yasutoshi, Tolcher, Anthony, Kurokawa, Misaki, Munasinghe, Wijith, Phillips, Andrew, Souers, Andrew, Johnson, Eric, He, Lei, Weitzman, Aaron, Powderly, John, Lorusso, Patricia, Naito, Yoichi

Source: In Annals of Oncology November 2023 34 Supplement 3:S1420-S1420

A Phase 1 and Biodistribution Study of ABT-806i, An Indium-111 Radiolabeled Conjugate of the Tumor-Specific Anti-EGFR Antibody ABT-806.

Authors: Gan, Hui K., Burge, Matthew, Solomon, Benjamin, Lee, Sze Ting, Holen, Kyle D., Yumin Zhang, Ciprotti, Marika, Lee, F. T., Munasinghe, Wijith, Fischer, JuDee, Ansell, Peter, Fox, Gerard, Hao Xiong, Reilly, Edward B., Humerickhouse, Rod, Scott, Andrew M.

Source: Journal of Nuclear Medicine; Dec2021, Vol. 62 Issue 12, p1-29, 30p

A Phase 1 and Biodistribution Study of ABT-806i, An Indium-111 Radiolabeled Conjugate of the Tumor-Specific Anti-EGFR Antibody ABT-806.

Authors: Hui K. Gan, Burge, Matthew, Solomon, Benjamin, Sze Ting Lee, Holen, Kyle D., Yumin Zhang, Ciprotti, Marika, Lee, F. T., Munasinghe, Wijith, Fischer, JuDee, Ansell, Peter, Fox, Gerard, Hao Xiong, Reilly, Edward B., Humerickhouse, Rod, Scott, Andrew M.

Source: Journal of Nuclear Medicine; 8/1/2021, Vol. 62 Issue 8, p1-30, 30p

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Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR.

Authors: Munasinghe, Wijith¹, Mittapalli, Rajendar², Li, Hong¹, Hoffman, David¹, Holen, Kyle³, Menon, Rajeev², Xiong, Hao² hao.xiong@abbvie.com, Munasinghe, Wijith P⁴ (AUTHOR), Mittapalli, Rajendar K⁵ (AUTHOR), Hoffman, David M⁴ (AUTHOR), Holen, Kyle D⁶ (AUTHOR), Menon, Rajeev M⁵ (AUTHOR)

Source: Cancer Chemotherapy & Pharmacology. May2017, Vol. 79 Issue 5, p915-922. 8p.

Subject Terms: *EPIDERMAL growth factor receptors, *ANTIBODY-drug conjugates, *GENETIC overexpression, *TUMOR treatment, *INTRAVENOUS therapy, *DRUG development

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