Spots Global Cancer Trial Database for Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
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Trial Identification
Brief Title: Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
Official Title: An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
Study ID: NCT01938638
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents. The purpose of this study Part B is: Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
Detailed Description:
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Fayetteville, Arkansas, United States
, Boston, Massachusetts, United States
, Ann Arbor, Michigan, United States
, Hackensack, New Jersey, United States
, New York, New York, United States
, Charleston, South Carolina, United States
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Singapore, , Singapore
, Singapore, , Singapore
, Taipei, , Taiwan
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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