A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

Descriptive Information
Brief Title † A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma
Official Title † A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma
Brief Summary First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma
Detailed Description Study Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts: Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a 7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (CRM). Part 1b will evaluate the safety and tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The dose expansion part of the study (Part 2) can open once the MTD has been determined in Part 1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification (liposarcoma [LPS], gliobastoma [ GBM ] and all other solid tumors) or potentially harboring MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple myeloma.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Safety
Secondary Outcome Measure † Objective Tumor Response
Condition † Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Glioblastoma Multiple Myeloma
Intervention † DrugAMG 232
Study Arms / Comparison Groups AMG 232 AMG 232 is an anti-cancer agent.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 107
Start Date † December 27, 2012
Completion Date September 25, 2017
Primary Completion Date March 15, 2017
Eligibility Criteria † Inclusion Criteria: - Men or women > 18 years old - Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma - Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma. - Ability to take oral medications and willing to record daily adherance to investigational product - Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion Criteria: - Active brain metastases - For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years - Active infection requiring intravenous (IV) antibiotics - Anti-tumor therapy - Therapeutic or palliative radiation therapy within 30 days of starting treatment - Currently enrolled in another investigational device or drug study
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT01723020
Organization ID 20120106
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Amgen
Collaborators ††
Investigators † Study Director: MD, Amgen
Information Provided By
Verification Date March 2017
First Received Date † November 5, 2012
Last Updated Date April 4, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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