AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Study Purpose

At least one dose level of AMG 176 will achieve acceptable safety and tolerability in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia

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 - 85 Years
Gender All
More Inclusion & Exclusion Criteria

INCLUSION CRITERIA:

  • - For participants in Japan only: if a participant is younger than 20 years at the time of signing the informed consent form, informed consent must be obtained from both the participant and his/her legal representative.
  • - (Multiple myeloma subjects) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy.
  • - (MM subjects only) Measurable disease per the IMWG response criteria.
  • - (Acute myeloid leukemia subjects) AML as defined by the World Health Organization (WHO) Classification persisting or recurring following one or more treatment courses, and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic leukemia.
  • - (AML subjects only) More than 5% blasts in bone marrow and Circulating white blood cells (WBCs) < 25,000/ul.
  • - Must be willing and able to undergo a core bone marrow biopsy (MM subjects only) and bone marrow aspirate (MM and AML subjects) at screening.
  • - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2, - (MM subjects only) Satisfactory hematological function without transfusion or growth factor support.
  • - Life expectancy of > 3 months, in the opinion of the investigator.
  • - Adequate hepatic function.
  • - Adequate cardiac function.
  • - Adequate renal function.
  • - Female subjects of childbearing potential must have a negative serum or urine pregnancy test.
  • - Other inclusion criteria may apply.

EXCLUSION CRITERIA:

  • - Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease.
  • - Autologous stem cell transplant less than 90 days prior to study day 1.
  • - (MM subjects only) Multiple myeloma with IgM subtype.
  • - (MM subjects only) POEMS syndrome.
  • - (MM subjects only) Existing plasma cell leukemia.
  • - (MM subjects only) Waldenstrom's macroglobulinemia.
  • - (MM subjects only) Amyloidosis.
  • - (Acute myeloid leukemia Part 4 only) Presence of advanced malignant hepatic tumors with baseline albumin < 3 g/dL.
  • - Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1) - Myocardial infarction within 6 months of enrollment, symptomatic congestive heart failure (New York Heart Association > class II) - History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months prior to enrollment.
  • - Currently receiving treatment in another investigational device or drug study.
Other investigational procedures while participating in this study will be allowed if approved by Amgen medical monitor.
  • - Participants with elevated cardiac troponin above the manufacturer's 99th percentile upper reference limit for ADVIA Centaur XP assay at screening performed by the central laboratory.
  • - Participants with evidence of recent cardiac injury at screening based on creatine kinase-muscle/brain (CK-MB), N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), and electrocardiogram (ECG) - Other exclusion criteria may apply.
- (Acute myeloid leukemia Part 3d only) History of QT prolongation, torsades de pointes, ventricular tachycardia and cardiac arrest

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.

NCT02675452
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.

Amgen
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 Recruiting
Countries Australia, Canada, Germany, Japan, United States
Conditions

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

Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Acute Myeloid Leukemia
Study Website: View Trial Website
Additional Details

This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia The study will be conducted in four parts.

Arms & Interventions

Arms

Experimental: AMG 176 - Part 1a

Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break.

Experimental: AMG 176 - Part 1b

Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3a

Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break.

Experimental: AMG 176 - Part 3b

Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3c

Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.

Experimental: AMG 176 - Part 3d

Part 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole.

Experimental: AMG 176 - Part 4

Part 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break, in combination with azacitidine.

Interventions

Drug: - AMG 176

Study Drug

Drug: - Azacitidine

Non-investigational product

Drug: - Itraconazole

Non-investigational product

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.

City of Hope National Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope National Medical Center

Duarte, California, 91010

Sacramento, California

Status

Recruiting

Address

University of California Davis Medical Center

Sacramento, California, 95817

Northside Hospital, Atlanta, Georgia

Status

Recruiting

Address

Northside Hospital

Atlanta, Georgia, 30342

University of Chicago Hospital, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Hospital

Chicago, Illinois, 60637

University Medical Center New Orleans, New Orleans, Louisiana

Status

Terminated

Address

University Medical Center New Orleans

New Orleans, Louisiana, 70112

Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Hackensack, New Jersey

Status

Recruiting

Address

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112

International Sites

Royal North Shore Hospital, St Leonards, New South Wales, Australia

Status

Recruiting

Address

Royal North Shore Hospital

St Leonards, New South Wales, 2065

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

The Royal Melbourne Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

The Royal Melbourne Hospital

Parkville, Victoria, 3050

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Centre

Calgary, Alberta, T2N 2T9

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network-Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Aachen, Germany

Status

Recruiting

Address

Universitätsklinikum der Rheinisch-Westfälischen Technischen Hochschule Aachen

Aachen, , 52074

Universitätsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitätsklinikum Bonn

Bonn, , 53127

Universitatsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitatsklinikum Ulm

Ulm, , 89081

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

National Hospital Organization Nagoya Medical Center

Nagoya-shi, Aichi, 460-0001

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

Status

Recruiting

Address

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577

Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

National Hospital Organization Kyushu Cancer Center

Fukuoka-shi, Fukuoka, 811-1395

Okayama-shi, Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama-shi, Okayama, 701-1192

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, Japan

Status

Recruiting

Address

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625