Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Multiple Myeloma, NHL, and AML

Overview

This is a first-in-human (FIH), multicenter, non-randomized, open-label, phase 1 study evaluating AMG 397 administered orally once daily for 2 consecutive days followed by 5 days break at a weekly interval, as part of a 28-day treatment cycle in adult subjects with multiple myeloma, non-Hodgkin's lymphoma, and acute myeloid leukemia.

AMG 397 administered orally once daily for 2 consecutive days followed by 5 days break at a weekly interval, as part of a 28-day treatment cycle in adult subjects with selected RR hematological malignancies

SparkCures ID 988
Trial Phase Phase 1
Enrollment 90 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT03465540

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age ≥ 18 years old
  • Pathologically-documented, definitively-diagnosed relapsed or refractory MM, NHL, or AML and is intolerant to, or considered ineligible for available therapies known to provide clinical benefit. -

MM subjects only: Measurable disease per the IMWG response criteria, as indicated by one or more of the following: Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours. For Subjects who do not meet 1 of the 2 prior criteria: Serum Free Light Chain (sFLC) ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal sFLC ratio (< 0.26 or > 1.65) as per the IMWG response criteria

  • NHL subjects only: Radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
  • AML subjects only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification, More than 5% blasts in bone marrow
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption
  • Hepatic function, as follows: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN), Total bilirubin (TBIL) < 1.5 X ULN (except subjects with Gilbert's syndrome)
  • Cardiac function, as follows: Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by an ECHO or MUGA, No clinically significant ECG findings.
  • Renal function as follows: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault [(140 - Age) × Mass (kg) / (72 × serum creatinine mg/dL)]. Multiply result by 0.85 if female.

Exclusion Criteria:

  • Previously received an allogeneic stem cell transplant within 6 months of study day 1 OR having signs or symptoms of acute or chronic graft-versus-host disease
  • Autologous stem cell transplant < 90 days prior to study day 1
  • Candidates for stem cell transplant should have failed or are not considered eligible for either allogeneic and autologous transplant
  • Myocardial infarction within 6 months of study day 1
  • 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 study day 1
  • Infection requiring intravenous anti-infective treatments within 1 week of study day 1
  • Known positive results for human immunodeficiency virus (HIV)
  • Active hepatitis B and C based on the following results: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic, hepatitis B or recent acute hepatitis B), Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
  • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria with the exception of grade 2peripheral neuropathy, alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 4 weeks prior to study day 1 may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)
  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent or procedures) within 14 days of day 1
  • Prior systemic radiation therapy must have been completed at least 28 days before study day 1. Prior focal radiotherapy completed at 14 days before study day 1
  • Males and females of reproductive potential who are unwilling to practice an acceptable method(s) of effective birth control while on study through 3 months after receiving the last dose of study drug. Acceptable methods of effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with barrier methods (diaphragm, cervical cap, or cervical sponge), hormonal birth control or IUD (females)
  • Females who are lactating/breastfeeding or who plan to breastfeed while on study through 3 months after receiving the last dose of study drug
  • Females with a positive pregnancy test or planning to become pregnant while on study through 3 months after receiving the last dose of study drug
  • Males who are unwilling to abstain from sperm donation while on study through 3 months after receiving the last dose of study drug

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Medical College of Wisconsin<br />Froedtert Hospital

SparkCures Verified Accurate, up-to-date information. Learn more


Mayo Clinic Hospital

Phoenix, AZ

Mayo Clinic (Jacksonville)

Jacksonville, FL

Arizona
Mayo Clinic Hospital

Phoenix, AZ

Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Kansas
Maryland
Missouri
New York
Texas
Wisconsin
Verified Medical College of Wisconsin<br />Froedtert Hospital

SparkCures Verified Accurate, up-to-date information. Learn more

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

There are no resources, links or videos to display for this clinical trial.