Spots Global Cancer Trial Database for A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
Official Title: A Phase 1b/2 Study of AV-299 (Formerly SCH 900105) in Combination With Gefitinib in Asian Subjects With Non-Small Cell Lung Cancer (P06162)
Study ID: NCT01039948
Study Description
Brief Summary: During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumor. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion. The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of AV-299 (formerly SCH900105) and gefitinib versus gefitinib alone in clinically selected Asian subjects with previously untreated lung adenocarcinoma who have a high likelihood of harboring activating EGFR mutations. Subjects who progress after initial disease control in the gefitinib alone arm may crossover to the combination arm.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site 1, Shatin N.T., , Hong Kong
Investigational Site 2, Chungcheongbuk-do, , Korea, Republic of
Investigational Site 3, Gyeonggi-do, , Korea, Republic of
Investigational Site 4, Jeollanam-do, , Korea, Republic of
Investigational Site 5, Seoul, , Korea, Republic of
Investigational Site 6, Seoul, , Korea, Republic of
Investigational Site 7, Seoul, , Korea, Republic of
Investigational Site 8, Seoul, , Korea, Republic of
Investigational Site 10, Kuala Lumpur, , Malaysia
Investigational Site 9, Kuala Lumpur, , Malaysia
Investigational Site 11, Pahang, , Malaysia
Investigational Site 12, Manila, , Philippines
Investigational Site 13, Pasig City, , Philippines
Investigational Site 14, Quezon City, , Philippines
Investigational Site 15, Singapore, , Singapore
Investigational Site 16, Changhua, , Taiwan
Investigational Site 17, Chiayi, , Taiwan
Investigational Site 18, Taichung, , Taiwan
Investigational Site 19, Tainan, , Taiwan
Investigational Site 20, Taipei, , Taiwan
Investigational Site 21, Taipei, , Taiwan
Investigational Site 22, Taoyuan, , Taiwan
Investigational Site 23, Bangkok, , Thailand
Investigational Site 24, Chiang Mai, , Thailand
Investigational Site 25, KhonKaen, , Thailand
Investigational Site 26, Songkla, , Thailand
Contact Details
Name: Philip Komarnitsky, MD
Affiliation: AVEO Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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