ASCEND-8: A Randomized Phase 1 Study of Ceritinib, 450 mg or 600 mg, Taken with a Low-Fat Meal versus 750 mg in Fasted State in Patients with Anaplastic.

Slides:



Advertisements
Similar presentations
Elderly Patients with Advanced NSCLC in Phase III Clinical Trials: Are the Elderly Excluded from Practice-Changing Trials in Advanced NSCLC?  Adrian G.
Advertisements

Liver Metastasis Is Associated with Poor Progression-Free Survival in Patients with Non–Small Cell Lung Cancer Treated with Nivolumab  Tomoko Funazo,
Perioperative versus Preoperative Chemotherapy with Surgery in Patients with Resectable Squamous Cell Carcinoma of Esophagus  Yang Zhao, MD, ZhiJun Dai,
Sarah J. Gao, BS, Christopher D. Corso, MD, PhD, Elyn H
SC17.02 Lung Cancer in China: Challenges and Perspectives
ALK FISH and IHC: You Cannot Have One without the Other
Role of Postoperative Radiotherapy in Pathologic Stage IIIA (N2) Non–Small Cell Lung Cancer in a Prospective Nationwide Oncology Outcomes Database  Alex.
Jessica J. Lin, MD, Lauren L. Ritterhouse, MD, PhD, Siraj M
Outcomes of Second-Line Chemotherapy in Patients with Relapsed Extensive Small Cell Lung Cancer  Sandra Froeschl, MD, Garth Nicholas, MD, FRCPC, Victor.
A Randomized, Phase 2 Trial of Docetaxel with or without PX-866, an Irreversible Oral Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Relapsed.
Role of Postoperative Radiotherapy in Pathologic Stage IIIA (N2) Non–Small Cell Lung Cancer in a Prospective Nationwide Oncology Outcomes Database  Alex.
Susan C. Scott, MD, Nathan A. Pennell, MD, PhD 
Patient-Reported Outcomes and Quality of Life in PROFILE 1007: A Randomized Trial of Crizotinib Compared with Chemotherapy in Previously Treated Patients.
P3.02b-001 Phase 1 Dose Escalation of PF (EGFR-T790M Inhibitor) in Patients with Advanced EGFRm (Del 19 or L858R+/-T790M) NSCLC  Hatim Husain,
Incidence of Brain Metastasis at the Initial Diagnosis of Lung Squamous Cell Carcinoma on the Basis of Stage, Excluding Brain Metastasis  Hyun Lee, MD,
Megan B. Barnet, BS, M. B. B. S. , Sandra O’Toole, PhD, Lisa G
Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients with Advanced Non–Small Cell Lung Cancer  Suzanne Jenkins, DPhil, James C-H.
Tetsuya Mitsudomi, MD, Hirohito Tada, MD  Journal of Thoracic Oncology 
A Brief Report of the Status of Central Nervous System Metastasis Enrollment Criteria for Advanced Non–Small Cell Lung Cancer Clinical Trials: A Review.
A Phase I/II Study of GTI-2040 Plus Docetaxel as Second-Line Treatment in Advanced Non-small Cell Lung Cancer: A Study of the PMH Phase II Consortium 
Clinical Outcome of ALK-Positive Non–Small Cell Lung Cancer (NSCLC) Patients with De Novo EGFR or KRAS Co-Mutations Receiving Tyrosine Kinase Inhibitors.
Prognostic Impact of Newly Proposed M Descriptors in TNM Classification of Non–Small Cell Lung Cancer  Junghoon Shin, MD, Bhumsuk Keam, MD, PhD, Miso.
Gefitinib (IRESSA) with Vinorelbine or Vinorelbine/Cisplatin for Chemotherapy-Naive Non-small Cell Lung Cancer Patients  Jean-Louis Pujol, MD, Patrick.
Successful Treatment with Crizotinib in Mechanically Ventilated Patients with ALK Positive Non–Small-Cell Lung Cancer  Hee Kyung Ahn, MD, Kyeongman Jeon,
Role of Local Ablative Therapy in Patients with Oligometastatic and Oligoprogressive Non–Small Cell Lung Cancer  Chul Kim, MD, MPH, Chuong D. Hoang, MD,
P3.02a-036 Phase 1 Study of Ceritinib 450 mg or 600 mg Taken with a Low-Fat Meal versus 750 mg in Fasted State in ALK+ Metastatic NSCLC  Rafal Dziadziuszko,
Ziad Thotathil, MD, FRCR, Jeremy Long, FRACP 
Central versus Peripheral Tumor Location: Influence on Survival, Local Control, and Toxicity Following Stereotactic Body Radiotherapy for Primary Non–Small-Cell.
Elderly Patients with Advanced NSCLC in Phase III Clinical Trials: Are the Elderly Excluded from Practice-Changing Trials in Advanced NSCLC?  Adrian G.
Telomere Length and Recurrence Risk after Curative Resection in Patients with Early- Stage Non–Small-Cell Lung Cancer: A Prospective Cohort Study  Eric.
The Influence of the Evolution of First-Line Chemotherapy on Steadily Improving Survival in Advanced Non-Small-Cell Lung Cancer Clinical Trials  Krista.
Liver Metastasis Is Associated with Poor Progression-Free Survival in Patients with Non–Small Cell Lung Cancer Treated with Nivolumab  Tomoko Funazo,
Prevention and Management of Bone Metastases in Lung Cancer: A Review
Mediastinal Lymph Node Examination and Survival in Resected Early-Stage Non– Small-Cell Lung Cancer in the Surveillance, Epidemiology, and End Results.
A Novel EML4-ALK Variant: Exon 6 of EML4 Fused to Exon 19 of ALK
George Blumenschein, MD, John V. Heymach, MD, PhD 
Jeffrey Bradley, MD, Issam El Naqa, PhD  Journal of Thoracic Oncology 
Association between Congenital Lung Malformations and Lung Tumors in Children and Adults: A Systematic Review  Arianna Casagrande, MD, Federica Pederiva,
Comparative Efficacy of Ceritinib and Crizotinib as Initial ALK–Targeted Therapies in Previously Treated Advanced NSCLC: An Adjusted Comparison with External.
Anaplastic Lymphoma Kinase Translocation: A Predictive Biomarker of Pemetrexed in Patients with Non-small Cell Lung Cancer  Jeong-Ok Lee, MD, Tae Min.
First-Line Pemetrexed plus Cisplatin followed by Gefitinib Maintenance Therapy versus Gefitinib Monotherapy in East Asian Never-Smoker Patients with Locally.
Socioeconomic Status Is Associated with Depressive Severity Among Patients with Advanced Non–Small-Cell Lung Cancer: Treatment Setting and Minority Status.
Strategies to Improve Outcomes of Patients with EGFR-Mutant Non–Small Cell Lung Cancer: Review of the Literature  Caicun Zhou, MD, PhD, Luan Di Yao, MD 
Maria Q. Baggstrom, MD, Saiama N. Waqar, MD, Ananth K
A Different Method in Diagnosis of Multiple Primary Lung Cancer
A Case of ALK-Rearranged Adenocarcinoma with Small Cell Carcinoma-Like Transformation and Resistance to Crizotinib  Yoon Jin Cha, MD, PhD, Byoung Chul.
Natural History and Factors Associated with Overall Survival in Stage IV ALK- Rearranged Non–Small Cell Lung Cancer  Jose M. Pacheco, MD, Dexiang Gao,
Appropriateness of Surgical Approach in Black Patients with Lung Cancer—15 Years Later, Little Has Changed  Emanuela Taioli, MD, PhD, Raja Flores, MD 
Vamsidhar Velcheti, MD  Journal of Thoracic Oncology 
Patients with Advanced Non–Small Cell Lung Cancer: Are Research Biopsies a Barrier to Participation in Clinical Trials?  Charles Lim, MD, Mike Sung, BSc,
An Unmet Need in the WHO 2015 Biopsy Classification: Poorly Differentiated NSCCs with Positive Neuroendocrine Markers  Jules L. Derks, MD  Journal of.
A Retrospective Analysis of VeriStrat Status on Outcome of a Randomized Phase II Trial of First-Line Therapy with Gemcitabine, Erlotinib, or the Combination.
A Double-Blind Randomized Discontinuation Phase-II Study of Sorafenib (BAY 43– 9006) in Previously Treated Non–Small-Cell Lung Cancer Patients: Eastern.
A Phase 2 Randomized Trial of Paclitaxel and Carboplatin with or without Panitumumab for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer 
Gemcitabine in Brief versus Prolonged Low-Dose Infusion, both Combined with Cisplatin, for Advanced Non-small Cell Lung Cancer: A Randomized Phase II.
Severe Aplastic Anemia during Osimertinib Therapy in a Patient with EGFR Tyrosine Kinase Inhibitor–Resistant Non–Small Cell Lung Cancer  Hiroaki Ogata,
Impact of Chronic Obstructive Pulmonary Disease on the Mortality of Patients with Non– Small-Cell Lung Cancer  Seung Jun Lee, MD, Jinwoo Lee, MD, Young.
Maintenance Therapy and Advanced Non–Small-Cell Lung Cancer: A Skeptic's View  Martin J. Edelman, MD, Thierry Le Chevalier, MD, Jean-Charles Soria, MD,
Pitfalls in Oncology: Osteoblastic Response Mimicking Bone Progression during Ceritinib Treatment in ALK-Rearranged NSCLC  Francesco Gelsomino, MD, Valentina.
Genetic Changes in Squamous Cell Lung Cancer: A Review
Ethnic Differences in the Management of Lung Cancer in New Zealand
Validity of International Association for the Study of Lung Cancer Proposals for the Revision of N Descriptors in Lung Cancer  Jin Gu Lee, MD, Chang Young.
Impact of Information on Quality of Life and Satisfaction of Non-small Cell Lung Cancer Patients: A Randomized Study of Standardized versus Individualized.
A Dramatic Response to Crizotinib in a Non–Small-Cell Lung Cancer Patient with IHC- Positive and FISH-Negative ALK  Jong-Mu Sun, MD, PhD, Yoon-La Choi,
Clinicopathologic Features of NSCLC Diagnosed During Pregnancy or the Peripartum Period in the Era of Molecular Genotyping  Ibiayi Dagogo-Jack, MD, Justin.
A Review of First-Line Treatment for Small-cell Lung Cancer
The Current Role of Whole Brain Radiation Therapy in Non–Small Cell Lung Cancer Patients  Gokoulakrichenane Loganadane, MD, Lizza Hendriks, MD, PhD, Cécile.
Mark A. Socinski, MD  Journal of Thoracic Oncology 
Robert Comis, MD, The Passing of a “Lung Man”
Reply to “Influence of Body Mass Index on Overall Survival Following Surgical Resection of Non–Small Cell Lung Cancer: Methodological Issues”  Boris Sepesi,
Presentation transcript:

ASCEND-8: A Randomized Phase 1 Study of Ceritinib, 450 mg or 600 mg, Taken with a Low-Fat Meal versus 750 mg in Fasted State in Patients with Anaplastic Lymphoma Kinase (ALK)-Rearranged Metastatic Non–Small Cell Lung Cancer (NSCLC)  Byoung Chul Cho, MD, PhD, Dong-Wan Kim, MD, PhD, Alessandra Bearz, MD, Scott A. Laurie, MD, FRCPC, Mark McKeage, MBChB, PhD, FRACP, Gloria Borra, MD, Keunchil Park, MD, PhD, Sang-We Kim, MD, Marwan Ghosn, MD, MHHM, Andrea Ardizzoni, MD, Evaristo Maiello, MD, Alastair Greystoke, MD, PhD, Richard Yu, BS, Karen Osborne, BSc, Wen Gu, PhD, Jeffrey W. Scott, BSc, Vanessa Q. Passos, MD, PhD, Yvonne Y. Lau, PhD, Anna Wrona, MD  Journal of Thoracic Oncology  Volume 12, Issue 9, Pages 1357-1367 (September 2017) DOI: 10.1016/j.jtho.2017.07.005 Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 CONSORT trial flow diagram. PK, pharmacokinetics. Journal of Thoracic Oncology 2017 12, 1357-1367DOI: (10.1016/j.jtho.2017.07.005) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Steady-state pharmacokinetics on cycle 2 day 1 (pharmacokinetics analysis set–steady state [n = 97]). Journal of Thoracic Oncology 2017 12, 1357-1367DOI: (10.1016/j.jtho.2017.07.005) Copyright © 2017 International Association for the Study of Lung Cancer Terms and Conditions