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Alex A. Adjei
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Journal Articles

Design and Conduct of Early Clinical Studies of Immunotherapy: Recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies 2019 (MDICT)

Martin Smoragiewicz, Alex A. Adjei, Emiliano Calvo, Josep Tabernero, Aurélien Marabelle, Christophe Massard, Jun Tang, Elisabeth G.E. de Vries, Jean-Yves Douillard, Lesley Seymour
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (11): 2461–2465.
https://doi.org/10.1158/1078-0432.CCR-19-3136
Published: 01 June 2020
View article titled, Design and Conduct of Early Clinical Studies of Immunotherapy: Recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies 2019 (MDICT)
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Journal Articles

A Phase I Clinical Trial and Independent Patient-Derived Xenograft Study of Combined Targeted Treatment with Dacomitinib and Figitumumab in Advanced Solid Tumors

Emiliano Calvo, Jean-Charles Soria, Wen Wee Ma, Tao Wang, Rastilav Bahleda, Anthony W. Tolcher, Diana Gernhardt, Joseph O'Connell, Robert Millham, Nagdeep Giri, Michael J. Wick, Alex A. Adjei, Manuel Hidalgo
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (5): 1177–1185.
https://doi.org/10.1158/1078-0432.CCR-15-2301
Published: 28 February 2017
View article titled, A Phase I Clinical Trial and Independent Patient-Derived Xenograft Study of Combined Targeted Treatment with Dacomitinib and Figitumumab in Advanced Solid Tumors
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Includes: Supplementary data
Journal Articles

A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Alex A. Adjei, Donald A. Richards, Anthony El-Khoueiry, Fadi Braiteh, Carlos H.R. Becerra, Joe J. Stephenson, Jr, Aram F. Hezel, Morris Sherman, Lawrence Garbo, Diane P. Leffingwell, Cory Iverson, Jeffrey N. Miner, Zancong Shen, Li-Tain Yeh, Sonny Gunawan, David M. Wilson, Kimberly J. Manhard, Prabhu Rajagopalan, Heiko Krissel, Neil J. Clendeninn
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (10): 2368–2376.
https://doi.org/10.1158/1078-0432.CCR-15-1681
Published: 12 May 2016
View article titled, A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer
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Includes: Supplementary data
Journal Articles

Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Colin D. Weekes, Daniel D. Von Hoff, Alex A. Adjei, Diane P. Leffingwell, S. Gail Eckhardt, Lia Gore, Karl D. Lewis, Glen J. Weiss, Ramesh K. Ramanathan, Grace K. Dy, Wen W. Ma, Beth Sheedy, Cory Iverson, Jeffrey N. Miner, Zancong Shen, Li-Tain Yeh, Ronald L. Dubowy, Michael Jeffers, Prabhu Rajagopalan, Neil J. Clendeninn
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (5): 1232–1243.
https://doi.org/10.1158/1078-0432.CCR-12-3529
Published: 03 March 2013
View article titled, Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer
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Includes: Supplementary data
Journal Articles

Phase I Study of Rigosertib, an Inhibitor of the Phosphatidylinositol 3-Kinase and Polo-like Kinase 1 Pathways, Combined with Gemcitabine in Patients with Solid Tumors and Pancreatic Cancer

Wen Wee Ma, Wells A. Messersmith, Grace K. Dy, Colin D. Weekes, Amy Whitworth, Chen Ren, Manoj Maniar, Francois Wilhelm, S. Gail Eckhardt, Alex A. Adjei, Antonio Jimeno
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (7): 2048–2055.
https://doi.org/10.1158/1078-0432.CCR-11-2813
Published: 01 April 2012
View article titled, Phase I Study of Rigosertib, an Inhibitor of the Phosphatidylinositol 3-Kinase and Polo-like Kinase 1 Pathways, Combined with Gemcitabine in Patients with Solid Tumors and Pancreatic Cancer
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Includes: Supplementary data
Journal Articles

Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials

Ming-Wen An, Sumithra J. Mandrekar, Megan E. Branda, Shauna L. Hillman, Alex A. Adjei, Henry C. Pitot, Richard M. Goldberg, Daniel J. Sargent
Journal: Clinical Cancer Research
Clin Cancer Res (2011) 17 (20): 6592–6599.
https://doi.org/10.1158/1078-0432.CCR-11-0822
Published: 14 October 2011
View article titled, Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials
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Includes: Supplementary data
Journal Articles

Novel Designs and End Points for Phase II Clinical Trials

Alex A. Adjei, Michaele Christian, Percy Ivy
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (6): 1866–1872.
https://doi.org/10.1158/1078-0432.CCR-08-2035
Published: 16 March 2009
View article titled, Novel Designs and End Points for Phase II Clinical Trials
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Journal Articles

Effective Incorporation of Biomarkers into Phase II Trials

Lisa M. McShane, Sally Hunsberger, Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (6): 1898–1905.
https://doi.org/10.1158/1078-0432.CCR-08-2033
Published: 16 March 2009
View article titled, Effective Incorporation of Biomarkers into Phase II Trials
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Journal Articles

Evaluation of Lapatinib and Topotecan Combination Therapy: Tissue Culture, Murine Xenograft, and Phase I Clinical Trial Data

Julian R. Molina, Scott H. Kaufmann, Joel M. Reid, Stephen D. Rubin, Marina Gálvez-Peralta, Robert Friedman, Karen S. Flatten, Kevin M. Koch, Tona M. Gilmer, Robert J. Mullin, Roxanne C. Jewell, Sara J. Felten, Sumithra Mandrekar, Alex A. Adjei, Charles Erlichman
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (23): 7900–7908.
https://doi.org/10.1158/1078-0432.CCR-08-0415
Published: 01 December 2008
View article titled, Evaluation of Lapatinib and Topotecan Combination Therapy: Tissue Culture, Murine Xenograft, and Phase I Clinical Trial Data
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Includes: Supplementary data
Journal Articles

Advances in Targeting the Ras/Raf/MEK/Erk Mitogen-Activated Protein Kinase Cascade with MEK Inhibitors for Cancer Therapy

Bret B. Friday, Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (2): 342–346.
https://doi.org/10.1158/1078-0432.CCR-07-4790
Published: 25 January 2008
View article titled, Advances in Targeting the Ras/Raf/MEK/Erk Mitogen-Activated Protein Kinase Cascade with MEK Inhibitors for Cancer Therapy
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Journal Articles

Phase I Dose Escalation Study of the Anti–Insulin-Like Growth Factor-I Receptor Monoclonal Antibody CP-751,871 in Patients with Refractory Solid Tumors

Paul Haluska, Heather M. Shaw, Gretchen N. Batzel, Donghua Yin, Julian R. Molina, L. Rhoda Molife, Timothy A. Yap, M. Luisa Roberts, Amarnath Sharma, Antonio Gualberto, Alex A. Adjei, Johann S. de Bono
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (19): 5834–5840.
https://doi.org/10.1158/1078-0432.CCR-07-1118
Published: 01 October 2007
View article titled, Phase I Dose Escalation Study of the Anti–Insulin-Like Growth Factor-I Receptor Monoclonal Antibody CP-751,871 in Patients with Refractory Solid Tumors
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Journal Articles

Phase I Trial of Sorafenib in Combination with Gefitinib in Patients with Refractory or Recurrent Non–Small Cell Lung Cancer

Alex A. Adjei, Julian R. Molina, Sumithra J. Mandrekar, Randolph Marks, Joel R. Reid, Gary Croghan, Lorelei J. Hanson, James R. Jett, Chenghua Xia, Chetan Lathia, Ronit Simantov
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (9): 2684–2691.
https://doi.org/10.1158/1078-0432.CCR-06-2889
Published: 01 May 2007
View article titled, Phase I Trial of Sorafenib in Combination with Gefitinib in Patients with Refractory or Recurrent Non–Small Cell Lung Cancer
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Journal Articles

Abrogation of MAPK and Akt Signaling by AEE788 Synergistically Potentiates Histone Deacetylase Inhibitor-Induced Apoptosis through Reactive Oxygen Species Generation

Chunrong Yu, Bret B. Friday, Jin-Ping Lai, Andrea McCollum, Peter Atadja, Lewis R. Roberts, Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (4): 1140–1148.
https://doi.org/10.1158/1078-0432.CCR-06-1751
Published: 22 February 2007
View article titled, Abrogation of MAPK and Akt Signaling by AEE788 Synergistically Potentiates Histone Deacetylase Inhibitor-Induced Apoptosis through Reactive Oxygen Species Generation
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Journal Articles

A Phase I Trial of Twice-Weekly 17-Allylamino-Demethoxy-Geldanamycin in Patients with Advanced Cancer

Grzegorz S. Nowakowski, Andrea K. McCollum, Matthew M. Ames, Sumithra J. Mandrekar, Joel M. Reid, Alex A. Adjei, David O. Toft, Stephanie L. Safgren, Charles Erlichman
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (20): 6087–6093.
https://doi.org/10.1158/1078-0432.CCR-06-1015
Published: 24 October 2006
View article titled, A Phase I Trial of Twice-Weekly 17-Allylamino-Demethoxy-Geldanamycin in Patients with Advanced Cancer
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Journal Articles

Novel Combinations Based on Epidermal Growth Factor Receptor Inhibition

Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (14): 4446s–4450s.
https://doi.org/10.1158/1078-0432.CCR-06-0623
Published: 20 July 2006
View article titled, Novel Combinations Based on Epidermal Growth Factor Receptor Inhibition
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Journal Articles

Summary Statement: Novel Agents in the Treatment of Lung Cancer: Advances in Epidermal Growth Factor Receptor-Targeted Agents

Thomas J. Lynch, Alex A. Adjei, Paul A. Bunn, Jr., Tim G. Eisen, Jeffrey Engelman, Glenwood D. Goss, Daniel A. Haber, John V. Heymach, Pasi A. Jänne, Bruce E. Johnson, David H. Johnson, Rogerio C. Lilenbaum, Matthew Meyerson, Alan B. Sandler, Lecia V. Sequist, Jeffrey Settleman, Kwok-Kin Wong, Carol S. Hart
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (14): 4365s–4371s.
https://doi.org/10.1158/1078-0432.CCR-06-1005
Published: 20 July 2006
View article titled, Summary Statement: Novel Agents in the Treatment of Lung Cancer: Advances in Epidermal Growth Factor Receptor-Targeted Agents
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Journal Articles

Phase I and Pharmacologic Study of Infusional Topotecan and Carboplatin in Relapsed and Refractory Acute Leukemia

Scott H. Kaufmann, Judith E. Karp, Louis Letendre, Timothy J. Kottke, Stephanie Safgren, Jackie Greer, Ivana Gojo, Pamela Atherton, Phyllis A. Svingen, David A. Loegering, Mark R. Litzow, Jeff A. Sloan, Joel M. Reid, Matthew M. Ames, Alex A. Adjei, Charles Erlichman
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (18): 6641–6649.
https://doi.org/10.1158/1078-0432.CCR-05-0817
Published: 15 September 2005
View article titled, Phase I and Pharmacologic Study of Infusional Topotecan and Carboplatin in Relapsed and Refractory Acute Leukemia
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Journal Articles

Phase 1 Trial of Flavopiridol Combined with Cisplatin or Carboplatin in Patients with Advanced Malignancies with the Assessment of Pharmacokinetic and Pharmacodynamic End Points

Keith C. Bible, Janet L. Lensing, Sacha A. Nelson, Yean K. Lee, Joel M. Reid, Matthew M. Ames, Crescent R. Isham, Jill Piens, Stacie L. Rubin, Joseph Rubin, Scott H. Kaufmann, Pamela J. Atherton, Jeffrey A. Sloan, Michelle K. Daiss, Alex A. Adjei, Charles Erlichman
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (16): 5935–5941.
https://doi.org/10.1158/1078-0432.CCR-04-2566
Published: 22 August 2005
View article titled, Phase 1 Trial of Flavopiridol Combined with Cisplatin or Carboplatin in Patients with Advanced Malignancies with the Assessment of Pharmacokinetic and Pharmacodynamic End Points
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Journal Articles

A Phase I and Pharmacologic Trial of Two Schedules of the Proteasome Inhibitor, PS-341 (Bortezomib, Velcade), in Patients with Advanced Cancer

Grace K. Dy, James P. Thomas, George Wilding, Laura Bruzek, Sumithra Mandrekar, Charles Erlichman, Dona Alberti, Kim Binger, Henry C. Pitot, Steven R. Alberts, Lorelei J. Hanson, Rebecca Marnocha, Kendra Tutsch, Scott H. Kaufmann, Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (9): 3410–3416.
https://doi.org/10.1158/1078-0432.CCR-04-2068
Published: 02 May 2005
View article titled, A Phase I and Pharmacologic Trial of Two Schedules of the Proteasome Inhibitor, PS-341 (Bortezomib, Velcade), in Patients with Advanced Cancer
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Journal Articles

A Phase I Trial of the Novel Farnesyl Protein Transferase Inhibitor, BMS-214662, in Combination with Paclitaxel and Carboplatin in Patients with Advanced Cancer

Grace K. Dy, Laura M. Bruzek, Gary A. Croghan, Sumithra Mandrekar, Charles Erlichman, Prema Peethambaram, Henry C. Pitot, Lorelei J. Hanson, Joel M. Reid, Alfred Furth, Shinta Cheng, Robert E. Martell, Scott H. Kaufmann, Alex A. Adjei
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (5): 1877–1883.
https://doi.org/10.1158/1078-0432.CCR-04-1769
Published: 08 March 2005
View article titled, A Phase I Trial of the Novel Farnesyl Protein Transferase Inhibitor, BMS-214662, in Combination with Paclitaxel and Carboplatin in Patients with Advanced Cancer
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