Spots Global Cancer Trial Database for Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
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Trial Identification
Brief Title: Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
Official Title: A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor
Study ID: NCT02485652
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
Detailed Description: This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Beverly Hills, California, United States
Research Site, Burbank, California, United States
Research Site 2, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Montebello, California, United States
Research Site, Orange, California, United States
Research Site, San Diego, California, United States
Research Site, Boca Raton, Florida, United States
Research Site, Honolulu, Hawaii, United States
Research Site, Evanston, Illinois, United States
Research Site, Bethesda, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Washington, Washington, United States
Research Site, Darlinghurst, , Australia
Research site, Fitzroy, , Australia
Research Site, Frankston, , Australia
Research Site, Kogarah, , Australia
Research Site, St Albans, , Australia
Research Site, Woolloongabba, , Australia
Research Site, Toronto, , Canada
Research Site, Berlin, , Germany
Research Site, Homburg, , Germany
Research Site, Leipzig, , Germany
Research Site, München, , Germany
Research Site, Ulm, , Germany
Research Site, Bergamo, , Italy
Research Site, Bologna, , Italy
Research Site, Catania, , Italy
Research Site, Milano, , Italy
Research Site, Rome, , Italy
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Hwasun, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site 2, Seongnam-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site 2, Seoul, , Korea, Republic of
Research Site 3, Seoul, , Korea, Republic of
Research Site 4, Seoul, , Korea, Republic of
Research Site 5, Seoul, , Korea, Republic of
Research Site 6, Seoul, , Korea, Republic of
Research Site 7, Seoul, , Korea, Republic of
Research Site 8, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, George Town, Penang, Malaysia
Research Site, Kuala Lumpur, , Malaysia
Research Site, Kuantan, , Malaysia
Research Site, Kuching, , Malaysia
Research Site, Makati, Kalakhang Maynila, Philippines
Research Site, Pasig, Manila, Philippines
Research Site 2, Manila, Metro Manila, Philippines
Research Site, Manila, Metro Manila, Philippines
Research Site, Cebu, , Philippines
Research Site 2, Barcelona, , Spain
Research Site 3, Barcelona, , Spain
Research Site 4, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, La Coruna, , Spain
Research Site 2, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Navarra, , Spain
Research Site, San Sebastian, , Spain
Research Site 2, Valencia, , Spain
Research Site, Valencia, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site 2, Tainan, , Taiwan
Research Site, Tainan, , Taiwan
Research Site 2, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Contact Details
Name: Keunchil Park, M.D., Ph.D
Affiliation: Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Pasi A. Jänne, M.D., Ph.D
Affiliation: Dana-Farber Cancer Institute, Boston, MA, USA
Role: PRINCIPAL_INVESTIGATOR
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