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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01723020
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kartos Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries France, Netherlands, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors, Glioblastoma, Multiple Myeloma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: AMG 232

AMG 232 is an anti-cancer agent.

Interventions

Drug: - AMG 232

Given an an oral tablet in escalating doses.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Santa Monica, California

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Address

Research Site

Santa Monica, California, 90403

Research Site, Norwalk, Connecticut

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Address

Research Site

Norwalk, Connecticut, 06856

Research Site, Boston, Massachusetts

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Address

Research Site

Boston, Massachusetts, 02115

Research Site, Boston, Massachusetts

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Address

Research Site

Boston, Massachusetts, 02215

Research Site, Hackensack, New Jersey

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Address

Research Site

Hackensack, New Jersey, 07601

Research Site, New Brunswick, New Jersey

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Address

Research Site

New Brunswick, New Jersey, 08901

Research Site, New York, New York

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Address

Research Site

New York, New York, 10021

Greenville Hospital System, Greenville, South Carolina

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Address

Greenville Hospital System

Greenville, South Carolina, 29605

Research Site, Greenville, South Carolina

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Address

Research Site

Greenville, South Carolina, 29605

International Sites

Research Site, Lyon CEDEX 08, France

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Address

Research Site

Lyon CEDEX 08, , 69373

Research Site, Villejuif, France

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Address

Research Site

Villejuif, , 94805

Research Site, Amsterdam, Netherlands

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Address

Research Site

Amsterdam, , 1066 CX

Research Site, Rotterdam, Netherlands

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Address

Research Site

Rotterdam, , 3015 CE

Research Site, Utrecht, Netherlands

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Address

Research Site

Utrecht, , 3584 CX