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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01723020
Other study ID # 20120106
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 27, 2012
Est. completion date September 25, 2017

Study information

Verified date August 2021
Source Kartos Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date September 25, 2017
Est. primary completion date March 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
AMG 232
Given an an oral tablet in escalating doses.

Locations

Country Name City State
France Research Site Lyon CEDEX 08
France Research Site Villejuif
Netherlands Research Site Amsterdam
Netherlands Research Site Rotterdam
Netherlands Research Site Utrecht
United States Research Site Boston Massachusetts
United States Research Site Boston Massachusetts
United States Greenville Hospital System Greenville South Carolina
United States Research Site Greenville South Carolina
United States Research Site Hackensack New Jersey
United States Research Site New Brunswick New Jersey
United States Research Site New York New York
United States Research Site Norwalk Connecticut
United States Research Site Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Kartos Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of AMG 232 Subject incidence of adverse events, dose limiting toxicities, and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests 36 months
Secondary Objective Tumor Response Duration of overall response and duration of stable disease measured by CT or MRI and assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, for multiple myeloma using IMWG response criteria 36 months
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