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Phase I Dose Escalation Study of Taselisib (GDC-0032), an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors

Dejan Juric, Ian Krop, Ramesh K. Ramanathan, Timothy R Wilson, Joseph A Ware, Sandra Sanabria Bohorquez, Heidi Savage, Deepak Sampath, Laurent Salphati, Ray Lin, Huan Jin, Hema Parmar, Jerry Y. Hsu, Daniel D. Von Hoff and José Baselga
Dejan Juric
Massachusetts General Hospital
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Ian Krop
Medical Oncology, Dana-Farber Cancer Institute
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Ramesh K. Ramanathan
Clinical Trials Program, Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen
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Timothy R Wilson
Oncology Biomarker Development, Genentech Inc.
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Joseph A Ware
Clinical Pharmacology, Genentech Inc.
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Sandra Sanabria Bohorquez
Early Development, Genentech Inc.
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Heidi Savage
Oncology Biomarker Development, Genentech Inc.
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Deepak Sampath
Translational Oncology, Genentech Inc.
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Laurent Salphati
Drug Metabolism and Pharmacokinetics, Genentech Inc.
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Ray Lin
Clinical Pharmacology, Genentech Inc.
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Huan Jin
Genentech Inc.
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Hema Parmar
Early Development Oncology, Genentech Inc.
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Jerry Y. Hsu
Genentech Inc.
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Daniel D. Von Hoff
Translational Genomic Research Institute and Virginia G. Piper Cancer Center
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José Baselga
Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center
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  • For correspondence: baselgaj@mskcc.org
DOI: 10.1158/2159-8290.CD-16-1080
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    • Supplementary Tables 1 through 4 and Supplementary Figures 1 through 7 - Supplementary Table S1. Patient Demographics and Disease Characteristics. Supplementary Table S2. Treatment-Related Adverse Events of Grade 3 or Higher Observed in either Cycle 1 or Cycle greater than or equal to 2. Supplementary Table S3. Adverse Events in greater than or equal to 10% of Patients Regardless of Attribution. Supplementary Table S4. Adverse Events of Grade 3 or Higher Regardless of Attribution. Supplementary Figure S1. Trellis plot of individual and fitted tumor volumes to day 21 following treatment with taselisib (GDC-0032). Supplementary Figure S2. PI3K pathway suppression was evaluated in KPL-4 tumor xenografts following a single oral dose of 1, 5 and 25 mg/kg taselisib or MCT (0.5% methylcellulose/0.2% Tween-80) vehicle at the time points indicated. Supplementary Figure S3. Schematic showing the decision-making related to selection of recommended dose for future studies. Supplementary Figure S4. Mean plasma concentration vs. time following single dose on day 1 (A) and multiple dose on day 15 (B). Supplementary Figure S5. Duration of treatment of patients treated via PIK3CA mutation status and dose level. Supplementary Figure S6. Antitumor activity observed with taselisib treatment. Supplementary Figure S7. Example of patient with partial response upon taselisib treatment and changes in circulating tumor DNA (ctDNA).
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Published OnlineFirst March 22, 2017
doi: 10.1158/2159-8290.CD-16-1080

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Phase I Dose Escalation Study of Taselisib (GDC-0032), an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors
Dejan Juric, Ian Krop, Ramesh K. Ramanathan, Timothy R Wilson, Joseph A Ware, Sandra Sanabria Bohorquez, Heidi Savage, Deepak Sampath, Laurent Salphati, Ray Lin, Huan Jin, Hema Parmar, Jerry Y. Hsu, Daniel D. Von Hoff and José Baselga
Cancer Discov March 22 2017 DOI: 10.1158/2159-8290.CD-16-1080

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Phase I Dose Escalation Study of Taselisib (GDC-0032), an Oral PI3K Inhibitor, in Patients with Advanced Solid Tumors
Dejan Juric, Ian Krop, Ramesh K. Ramanathan, Timothy R Wilson, Joseph A Ware, Sandra Sanabria Bohorquez, Heidi Savage, Deepak Sampath, Laurent Salphati, Ray Lin, Huan Jin, Hema Parmar, Jerry Y. Hsu, Daniel D. Von Hoff and José Baselga
Cancer Discov March 22 2017 DOI: 10.1158/2159-8290.CD-16-1080
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