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Journal Articles

Concordance between tumor tissue and plasma DNA genotyping in the NCI-MATCH trial (EAY131)

Available to Purchase
Mohamed A. Gouda, Filip Janku, Ying Yuan, Leylah M. Drusbosky, Alice P. Chen, Xiaofeng Zheng, Keyur Patel, Stanley R. Hamilton, Mark Routbort, James V. Tricoli, P. Mickey Williams, A. John Iafrate, Jeffrey Sklar, Brent Coffey, Richard F. Little, Carlos L. Arteaga, Peter J. O'Dwyer, Keith T. Flaherty, Lyndsay N. Harris, Funda Meric-Bernstam
Journal: Clinical Cancer Research
Clin Cancer Res (2025)
https://doi.org/10.1158/1078-0432.CCR-24-3531
Published: 19 May 2025
View articletitled, Concordance between tumor tissue and plasma DNA genotyping in the NCI-MATCH trial (EAY131)
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Includes: Supplementary data
Journal Articles

Phase I Study of SYNB1891, an Engineered E. coli Nissle Strain Expressing STING Agonist, with and without Atezolizumab in Advanced Malignancies

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Jason J. Luke, Sarina A. Piha-Paul, Theresa Medina, Claire F. Verschraegen, Mary Varterasian, Aoife M. Brennan, Richard J. Riese, Anna Sokolovska, James Strauss, David L. Hava, Filip Janku
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (13): 2435–2444.
https://doi.org/10.1158/1078-0432.CCR-23-0118
Published: 05 July 2023
View articletitled, Phase I Study of SYNB1891, an Engineered E. coli Nissle Strain Expressing STING Agonist, with and without Atezolizumab in Advanced Malignancies
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Includes: Supplementary data
Journal Articles

Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial

Open Access
Ingo K. Mellinghoff, Marta Penas-Prado, Katherine B. Peters, Howard A. Burris, III, Elizabeth A. Maher, Filip Janku, Gregory M. Cote, Macarena I. de la Fuente, Jennifer L. Clarke, Benjamin M. Ellingson, Saewon Chun, Robert J. Young, Hua Liu, Sung Choe, Min Lu, Kha Le, Islam Hassan, Lori Steelman, Shuchi S. Pandya, Timothy F. Cloughesy, Patrick Y. Wen
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (16): 4491–4499.
https://doi.org/10.1158/1078-0432.CCR-21-0611
Published: 15 August 2021
View articletitled, Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial
Open the PDF for Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial in another window
Includes: Supplementary data
Journal Articles

Phase I Assessment of Safety and Therapeutic Activity of BAY1436032 in Patients with IDH1-Mutant Solid Tumors

Free
Antje Wick, Oliver Bähr, Martin Schuler, Kristoffer Rohrberg, Sant P. Chawla, Filip Janku, David Schiff, Volker Heinemann, Yoshitaka Narita, Heinz-Josef Lenz, Masafumi Ikeda, Yuichi Ando, Wolfgang Wick, Joachim P. Steinbach, Michael C. Burger, Katharina Wenger, Ulrik Lassen, Kamalesh K. Sankhala, Cristiana Roggia, Isabelle Genvresse, Catya Munhoz, Christine Rentzsch, Susanne Reschke, Simon Langer, Markus Wagner, Stefan Kaulfuss, Charles Cai, Eleni Lagkadinou, Michael Jeffers, Carol Peña, Ghazaleh Tabatabai
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2021) 27 (10): 2723–2733.
https://doi.org/10.1158/1078-0432.CCR-20-4256
Published: 15 May 2021
View articletitled, Phase I Assessment of Safety and Therapeutic Activity of BAY1436032 in Patients with IDH1-Mutant Solid Tumors
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Includes: Supplementary data
Journal Articles

Phase I Study of Everolimus, Letrozole, and Trastuzumab in Patients with Hormone Receptor−positive Metastatic Breast Cancer or Other Solid Tumors

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Alexej Ballhausen, Jennifer J. Wheler, Daniel D. Karp, Sarina A. Piha-Paul, Siqing Fu, Shubham Pant, Apostolia M. Tsimberidou, David S. Hong, Vivek Subbiah, Veronica R. Holley, Helen J. Huang, Abenaa M. Brewster, Kimberly B. Koenig, Nuhad K. Ibrahim, Funda Meric-Bernstam, Filip Janku
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (5): 1247–1255.
https://doi.org/10.1158/1078-0432.CCR-20-2878
Published: 01 March 2021
View articletitled, Phase I Study of Everolimus, Letrozole, and Trastuzumab in Patients with Hormone Receptor−positive Metastatic Breast Cancer or Other Solid Tumors
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Journal Articles

Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-refractory Advanced Solid Tumors

Available to Purchase
Filip Janku, Halle Huihong Zhang, Abdulmohammad Pezeshki, Sanjay Goel, Ravi Murthy, Andrea Wang-Gillam, Dale R. Shepard, Thorunn Helgason, Tyler Masters, David S. Hong, Sarina A. Piha-Paul, Daniel D. Karp, Mark Klang, Steven Y. Huang, Divya Sakamuri, Anjali Raina, Jean Torrisi, Stephen B. Solomon, Alice Weissfeld, Ernest Trevino, Gary DeCrescenzo, Amanda Collins, Maria Miller, Jennifer L. Salstrom, Ronald L. Korn, Linping Zhang, Saurabh Saha, Alexey A. Leontovich, David Tung, Brent Kreider, Mary Varterasian, Khashayarsha Khazaie, Mrinal M. Gounder
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (1): 96–106.
https://doi.org/10.1158/1078-0432.CCR-20-2065
Published: 04 January 2021
View articletitled, Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-refractory Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma

Available to Purchase
Filip Janku, Haeseong Park, S. Greg Call, Kiran Madwani, Yasuhiro Oki, Vivek Subbiah, David S. Hong, Aung Naing, Vivianne M. Velez-Bravo, Tamara G. Barnes, Fredrick B. Hagemeister, Gerald S. Falchook, Daniel D. Karp, Jennifer J. Wheler, Sarina A. Piha-Paul, Ignacio Garrido-Laguna, Elizabeth J. Shpall, Luis E. Fayad, Sattva S. Neelapu, Funda Meric-Bernstam, Razelle Kurzrock, Michelle A. Fanale
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (21): 5579–5587.
https://doi.org/10.1158/1078-0432.CCR-20-1215
Published: 02 November 2020
View articletitled, Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma
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Includes: Supplementary data
Journal Articles

Cell-free Circulating Tumor DNA Variant Allele Frequency Associates with Survival in Metastatic Cancer

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Seyed Pairawan, Kenneth R. Hess, Filip Janku, Nora S. Sanchez, Kenna R. Mills Shaw, Cathy Eng, Senthilkumar Damodaran, Milind Javle, Ahmed O. Kaseb, David S. Hong, Vivek Subbiah, Siqing Fu, David R. Fogelman, Victoria M. Raymond, Richard B. Lanman, Funda Meric-Bernstam
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (8): 1924–1931.
https://doi.org/10.1158/1078-0432.CCR-19-0306
Published: 15 April 2020
View articletitled, Cell-free Circulating Tumor DNA Variant Allele Frequency Associates with Survival in Metastatic Cancer
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Includes: Supplementary data
Journal Articles

First-in-Man Phase I Trial of the Selective MET Inhibitor Tepotinib in Patients with Advanced Solid Tumors

Free
Gerald S. Falchook, Razelle Kurzrock, Hesham M. Amin, Wenyuan Xiong, Siqing Fu, Sarina A. Piha-Paul, Filip Janku, Ghazaleh Eskandari, Daniel V. Catenacci, Manfred Klevesath, Rolf Bruns, Uz Stammberger, Andreas Johne, Friedhelm Bladt, Manja Friese-Hamim, Pascal Girard, Samer El Bawab, David S. Hong
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2020) 26 (6): 1237–1246.
https://doi.org/10.1158/1078-0432.CCR-19-2860
Published: 13 March 2020
View articletitled, First-in-Man Phase I Trial of the Selective MET Inhibitor Tepotinib in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

A Phase I, Open-Label, Multicenter, Dose-escalation Study of the Oral Selective FGFR Inhibitor Debio 1347 in Patients with Advanced Solid Tumors Harboring FGFR Gene Alterations

Free
Martin H. Voss, Cinta Hierro, Rebecca S. Heist, James M. Cleary, Funda Meric-Bernstam, Josep Tabernero, Filip Janku, Leena Gandhi, A. John Iafrate, Darrell R. Borger, Nobuya Ishii, Youyou Hu, Yulia Kirpicheva, Valerie Nicolas-Metral, Anna Pokorska-Bocci, Anne Vaslin Chessex, Claudio Zanna, Keith T. Flaherty, Jose Baselga
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2019) 25 (9): 2699–2707.
https://doi.org/10.1158/1078-0432.CCR-18-1959
Published: 01 May 2019
View articletitled, A Phase I, Open-Label, Multicenter, Dose-escalation Study of the Oral Selective FGFR Inhibitor Debio 1347 in Patients with Advanced Solid Tumors Harboring FGFR Gene Alterations
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Includes: Supplementary data
Journal Articles

Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors

Free
David S. Hong, Patricia LoRusso, Omid Hamid, Filip Janku, Muaiad Kittaneh, Daniel V.T. Catenacci, Emily Chan, Tanios Bekaii-Saab, Shirish M. Gadgeel, Robert D. Loberg, Benny M. Amore, Yuying C. Hwang, Rui Tang, Gataree Ngarmchamnanrith, Eunice L. Kwak
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (8): 2403–2413.
https://doi.org/10.1158/1078-0432.CCR-18-1341
Published: 15 April 2019
View articletitled, Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

Liquid Biopsies Using Plasma Exosomal Nucleic Acids and Plasma Cell-Free DNA Compared with Clinical Outcomes of Patients with Advanced Cancers

Free
Lino Möhrmann, Helen J. Huang, David S. Hong, Apostolia M. Tsimberidou, Siqing Fu, Sarina A. Piha-Paul, Vivek Subbiah, Daniel D. Karp, Aung Naing, Anne Krug, Daniel Enderle, Tina Priewasser, Mikkel Noerholm, Erez Eitan, Christine Coticchia, Georg Stoll, Lisa-Marie Jordan, Cathy Eng, E. Scott Kopetz, Johan Skog, Funda Meric-Bernstam, Filip Janku
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (1): 181–188.
https://doi.org/10.1158/1078-0432.CCR-17-2007
Published: 02 January 2018
View articletitled, Liquid Biopsies Using Plasma Exosomal Nucleic Acids and Plasma Cell-Free DNA Compared with Clinical Outcomes of Patients with Advanced Cancers
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Includes: Supplementary data
Journal Articles

Development and Validation of an Ultradeep Next-Generation Sequencing Assay for Testing of Plasma Cell-Free DNA from Patients with Advanced Cancer

Free
Filip Janku, Shile Zhang, Jill Waters, Li Liu, Helen J. Huang, Vivek Subbiah, David S. Hong, Daniel D. Karp, Siqing Fu, Xuyu Cai, Nishma M. Ramzanali, Kiran Madwani, Goran Cabrilo, Debra L. Andrews, Yue Zhao, Milind Javle, E. Scott Kopetz, Rajyalakshmi Luthra, Hyunsung J. Kim, Sante Gnerre, Ravi Vijaya Satya, Han-Yu Chuang, Kristina M. Kruglyak, Jonathan Toung, Chen Zhao, Richard Shen, John V. Heymach, Funda Meric-Bernstam, Gordon B. Mills, Jian-Bing Fan, Neeraj S. Salathia
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (18): 5648–5656.
https://doi.org/10.1158/1078-0432.CCR-17-0291
Published: 14 September 2017
View articletitled, Development and Validation of an Ultradeep Next-Generation Sequencing Assay for Testing of Plasma Cell-Free DNA from Patients with Advanced Cancer
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Includes: Supplementary data
Journal Articles

Insurance Clearance for Early-Phase Oncology Clinical Trials Following the Affordable Care Act

Free
Kenneth L. Kehl, Cheryl P. Fullmer, Siqing Fu, Goldy C. George, Kenneth R. Hess, Filip Janku, Daniel D. Karp, Shumei Kato, Cynthia K. Kizer, Razelle Kurzrock, Aung Naing, Shubham Pant, Sarina A. Piha-Paul, Vivek Subbiah, Apostolia M. Tsimberidou, David S. Hong
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (15): 4155–4162.
https://doi.org/10.1158/1078-0432.CCR-16-3027
Published: 01 August 2017
View articletitled, Insurance Clearance for Early-Phase Oncology Clinical Trials Following the Affordable Care Act
Open the PDF for Insurance Clearance for Early-Phase Oncology Clinical Trials Following the Affordable Care Act in another window
Includes: Supplementary data
Journal Articles

Mutation-Enrichment Next-Generation Sequencing for Quantitative Detection of KRAS Mutations in Urine Cell-Free DNA from Patients with Advanced Cancers

Free
Takeo Fujii, Afsaneh Barzi, Andrea Sartore-Bianchi, Andrea Cassingena, Giulia Siravegna, Daniel D. Karp, Sarina A. Piha-Paul, Vivek Subbiah, Apostolia M. Tsimberidou, Helen J. Huang, Silvio Veronese, Federica Di Nicolantonio, Sandeep Pingle, Cecile Rose T. Vibat, Saege Hancock, David Berz, Vladislava O. Melnikova, Mark G. Erlander, Rajyalakshmi Luthra, E. Scott Kopetz, Funda Meric-Bernstam, Salvatore Siena, Heinz-Josef Lenz, Alberto Bardelli, Filip Janku
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3657–3666.
https://doi.org/10.1158/1078-0432.CCR-16-2592
Published: 13 July 2017
View articletitled, Mutation-Enrichment Next-Generation Sequencing for Quantitative Detection of KRAS Mutations in Urine Cell-Free DNA from Patients with Advanced Cancers
Open the PDF for Mutation-Enrichment Next-Generation Sequencing for Quantitative Detection of KRAS Mutations in Urine Cell-Free DNA from Patients with Advanced Cancers in another window
Includes: Supplementary data
Journal Articles

Bringing Blood-Based Molecular Testing to the Clinic

Free
Filip Janku, Razelle Kurzrock
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (22): 5400–5402.
https://doi.org/10.1158/1078-0432.CCR-16-1769
Published: 14 November 2016
View articletitled, Bringing Blood-Based Molecular Testing to the Clinic
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Journal Articles

A Phase Ib Dose-Escalation Study of the Oral Pan-PI3K Inhibitor Buparlisib (BKM120) in Combination with the Oral MEK1/2 Inhibitor Trametinib (GSK1120212) in Patients with Selected Advanced Solid Tumors

Free
Philippe L. Bedard, Josep Tabernero, Filip Janku, Zev A. Wainberg, Luis Paz-Ares, Johan Vansteenkiste, Eric Van Cutsem, José Pérez-García, Anastasios Stathis, Carolyn D. Britten, Ngocdiep Le, Kirsten Carter, David Demanse, Denes Csonka, Malte Peters, Angela Zubel, Heidi Nauwelaerts, Cristiana Sessa
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (4): 730–738.
https://doi.org/10.1158/1078-0432.CCR-14-1814
Published: 16 February 2015
View articletitled, A Phase Ib Dose-Escalation Study of the Oral Pan-PI3K Inhibitor Buparlisib (BKM120) in Combination with the Oral MEK1/2 Inhibitor Trametinib (GSK1120212) in Patients with Selected Advanced Solid Tumors
Open the PDF for A Phase Ib Dose-Escalation Study of the Oral Pan-PI3K Inhibitor Buparlisib (BKM120) in Combination with the Oral MEK1/2 Inhibitor Trametinib (GSK1120212) in Patients with Selected Advanced Solid Tumors in another window
Includes: Supplementary data
Journal Articles

Analysis of 1,115 Patients Tested for MET Amplification and Therapy Response in the MD Anderson Phase I Clinic

Free
Denis L.F. Jardim, Chad Tang, Debora De Melo Gagliato, Gerald S. Falchook, Kenneth Hess, Filip Janku, Siqing Fu, Jennifer J. Wheler, Ralph G. Zinner, Aung Naing, Apostolia M. Tsimberidou, Vijaykumar Holla, Marylin M. Li, Sinchita Roy-Chowdhuri, Raja Luthra, Ravi Salgia, Razelle Kurzrock, Funda Meric-Bernstam, David S. Hong
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (24): 6336–6345.
https://doi.org/10.1158/1078-0432.CCR-14-1293
Published: 14 December 2014
View articletitled, Analysis of 1,115 Patients Tested for MET Amplification and Therapy Response in the MD Anderson Phase I Clinic
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Includes: Supplementary data
Journal Articles

Synergy Between VEGF/VEGFR Inhibitors and Chemotherapy Agents in the Phase I Clinic

Free
Chad Tang, Kenneth Hess, Denis Leonardo F. Jardim, Debora De Melo Gagliato, Apostolia M. Tsimberidou, Gerald Falchook, Siqing Fu, Filip Janku, Aung Naing, Sarina Piha-Paul, Vivek Subbiah, Jennifer Wheler, Ralph G. Zinner, Razelle Kurzrock, Lee M. Ellis, Funda Meric-Berstam, David S. Hong
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (23): 5956–5963.
https://doi.org/10.1158/1078-0432.CCR-14-1582
Published: 30 November 2014
View articletitled, Synergy Between VEGF/VEGFR Inhibitors and Chemotherapy Agents in the Phase I Clinic
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Includes: Supplementary data
Journal Articles

Personalized Medicine for Patients with Advanced Cancer in the Phase I Program at MD Anderson: Validation and Landmark Analyses

Free
Apostolia-Maria Tsimberidou, Sijin Wen, David S. Hong, Jennifer J. Wheler, Gerald S. Falchook, Siqing Fu, Sarina Piha-Paul, Aung Naing, Filip Janku, Kenneth Aldape, Yang Ye, Razelle Kurzrock, Donald Berry
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (18): 4827–4836.
https://doi.org/10.1158/1078-0432.CCR-14-0603
Published: 14 September 2014
View articletitled, Personalized Medicine for Patients with Advanced Cancer in the Phase I Program at MD Anderson: Validation and Landmark Analyses
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Includes: Supplementary data