Spots Global Cancer Trial Database for Study of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients
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Trial Identification
Brief Title: Study of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients
Official Title: An Open-label, Dose Escalation, Phase I Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients.
Study ID: NCT02177682
Conditions
Interventions
Study Description
Brief Summary: Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the subjects meet any study treatment withdrawal criteria including disease progression. A total of up to 24 subjects will be enrolled in the study.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Aichi, , Japan
Novartis Investigative Site, Fukuoka, , Japan
Novartis Investigative Site, Miyagi, , Japan
Novartis Investigative Site, Niigata, , Japan
Novartis Investigative Site, Tokyo, , Japan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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