Spots Global Cancer Trial Database for AMG 319 Lymphoid Malignancy FIH
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Trial Identification
Brief Title: AMG 319 Lymphoid Malignancy FIH
Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies
Study ID: NCT01300026
Interventions
Study Description
Brief Summary: This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model \[CRM\] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Hackensack, New Jersey, United States
Research Site, Durham, North Carolina, United States
Research Site, Salt Lake City, Utah, United States
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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