Spots Global Cancer Trial Database for A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
Official Title: A Phase 1/2 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT02310321
Study Description
Brief Summary: The purpose of phase 1 part in this study is to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part will also evaluate safety and tolerability and characterize the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluate the PK parameters of cytarabine concomitant with ASP2215. The purpose of phase 2 part is to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort will also evaluate safety and characterize the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.
Detailed Description: This study is composed of Phase 1 part (the dose-evaluation part and the expansion part) and Phase 2 part. In the dose-evaluation part of Phase 1 part, at least 3 subjects will receive ASP2215 at each dose (low, middle, and high) for determination of MTD and/or RED. Treatment of AML in Phase 1 part is composed of 3 periods of therapy: remission induction, consolidation, and maintenance. The decision of whether or not to proceed to the next dose will be made based on the occurrence of DLT during Cycle 1 of the induction period. In the expansion part of Phase 1 part, a maximum of 3 subjects will receive ASP2215 at RED that has been recommended in the dose-evaluation part and the safety will be assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods. In Phase 2 part, Subjects will receive ASP2215 at the recommended dose established in Phase 1 part. The target population will be limited to newly diagnosed FLT3-mutated AML.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site JP81037, Anjo, Aichi, Japan
Site JP00003, Nagoya, Aichi, Japan
Site JP81003, Nagoya, Aichi, Japan
Site JP81027, Nagoya, Aichi, Japan
Site JP81038, Toyohashi, Aichi, Japan
Site JP81010, Narita, Chiba, Japan
Site JP81039, Matsuyama, Ehime, Japan
Site JP81007, Yoshida-gun, Fukui, Japan
Site JP00002, Maebashi, Gunma, Japan
Site JP81001, Maebshi, Gunma, Japan
Site JP81026, Fukuyama, Hiroshima, Japan
Site JP81018, Otake, Hiroshima, Japan
Site JP81014, Sapporo, Hokkaido, Japan
Site JP81015, Sapporo, Hokkaido, Japan
Site JP81043, Himeji, Hyogo, Japan
Site JP00007, Kobe, Hyogo, Japan
Site JP81006, Kobe, Hyogo, Japan
Site JP81036, Mito, Ibaraki, Japan
Site JP81023, Tsukuba, Ibaraki, Japan
Site JP81020, Kanazawa, Ishikawa, Japan
Site JP81013, Isehara, Kanagawa, Japan
Site JP00006, Yokohama, Kanagawa, Japan
Site JP81005, Yokohama, Kanagawa, Japan
Site JP81024, Yokohama, Kanagawa, Japan
Site JP81035, Sendai, Miyagi, Japan
SIte JP81011, Omura, Nagasaki, Japan
Site JP81041, Tenri, Nara, Japan
Site JP81022, Shimono, Tochigi, Japan
Site JP81040, Bunkyo-ku, Tokyo, Japan
Site JP00005, Shinagawa-ku, Tokyo, Japan
Site JP81032, Shinagawa-ku, Tokyo, Japan
Site JP81029, Akita, , Japan
Site JP81008, Chiba, , Japan
Site JP00001, Fukuoka, , Japan
Site JP81004, Fukuoka, , Japan
Site JP81025, Fukuoka, , Japan
Site JP81031, Fukushima, , Japan
Site JP81030, Gifu, , Japan
Site JP81033, Kochi, , Japan
Site JP81028, Kumamoto, , Japan
Site JP81016, Kyoto, , Japan
Site JP81012, Nagasaki, , Japan
Site JP81009, Okayama, , Japan
Site JP81019, Osaka, , Japan
Site JP81021, Osaka, , Japan
Site KR82002, Incheon, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site TW88604, Kaohsiung, , Taiwan
Site TW88602, Taichung, , Taiwan
Site TW88601, Tainan, , Taiwan
Site TW88603, Taoyuan, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Inc
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
