JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia

NCT03557970 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY00017583NCI-2018-00869
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well edicotinib (JNJ-40346527) works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. JNJ-40346527 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate

  An objective response is defined as achievement of a PR or any type of CR (CR, CRm, CRc, CRi) during a participant's first 2 cycles of study drug. Each participant's best disease response designation (amended from the IWG criteria specified by Cheson, 2003 JCO) during the first 2 cycles will be used when computing the best objective response rate. This rate will be reported alongside an exact confidence interval for each arm separately.

  first 2 cycles of study drug

Secondary Outcomes (4)

• Incidence of Treatment-related and Non-treatment Related Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  Start of study drug until 30 days after the last dose of study drug (while the participant remains on-study), which amounted to an average of 31 days for the 3 enrolled participants

• Duration of Response

  achievement of >=PR through end of study

• Event-free Survival

  study enrollment until last on-study disease assessment

• Overall Survival

  From study enrollment until end of participant follow-up (i.e., death or last contact), with the protocol specifying that "[p]articipants will be followed … until death"

Study Arms (1)

Treatment (JNJ-40346527)

EXPERIMENTAL

Participants receive JNJ-40346527 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Edicotinib; Other: Pharmacokinetic Study

Interventions

Edicotinib DRUG

Given PO

Also known as: JNJ-40346527

Treatment (JNJ-40346527)

Pharmacokinetic Study OTHER

Correlative studies

Also known as: PHARMACOKINETIC, PK Study

Treatment (JNJ-40346527)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ability to understand and the willingness to sign a written informed consent document.
• \. Age \>= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
• \. Morphologically documented relapsed/refractory AML as defined by World Health Organization (WHO) criteria after at least 1 prior therapy for AML with the exception of hydroxyurea, and not felt to have curative treatment options per treating physician, or the patients themselves are unwilling to consider curative treatment options.
• \. Sufficient and viable bone marrow aspirate or peripheral blood collection to use for the ex vivo sensitivity assay.
• \. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• \. Women must not be pregnant or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration.
• \. Participants must agree to use an adequate method contraception.
• \. Must be able to take oral medications.
• \. Adequate organ function as defined by the following:
• Serum creatinine =\< 2 x the upper limit of normal (ULN), or glomerular filtration rate \> 20 ml/min as calculated by Cockcroft-Gault formula.
• Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation.
• Total serum bilirubin =\< 2.5 x ULN.
• Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =\< 2.5 x ULN.

You may not qualify if:

• \. Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype).
• \. Active central nervous system involvement with AML.
• \. Concurrent active malignancy with expected survival of less than 1 year. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML. All subjects with concurrent malignancies will be reviewed by the principal investigator (PI) prior to enrollment.
• \. Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period.
• \. Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
• \. Participants who are currently receiving any other investigational agents.
• \. Previous treatment with CSF-1R kinase inhibitor or CSF-1R blocking antibody.
• \. Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis.
• \. Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin (IVIG) are eligible if hepatitis B \[HepB\] polymerase chain reaction \[PCR\] is negative).
• \. Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within 2 months of enrollment.
• \. Clinically significant surgery within 2 weeks of enrollment.
• \. Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy.
• \. Cancer-directed therapy within 2 weeks prior to starting treatment, with the exception of hydroxyurea, which is allowed to control white blood cell count. Hydroxyurea will be weaned as soon as clinically feasible.
• \. Unwillingness to receive infusion of blood products.
• \. Drugs that affect the CYP3A4 systems are allowed and essential for cancer patients, including anti-fungals but should be used with caution.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• Janssen, LP: collaborator
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

JNJ-40346527; Pharmacogenomic Variants

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Results Point of Contact

• Title: Elie Traer, MD PhD
• Organization: Oregon Health and Science University

traere@ohsu.edu

5034943553

Study Officials

• Elie Traer, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: October 5, 2018
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: December 2, 2021
• Results First Posted: December 2, 2021

Record last verified: 2021-12

Locations

US (1)