Study of KHK2823 in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

NCT02181699 | Terminated Phase 1 DMC

• 2 other identifiers: 2823-0012013-003657-21
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

Brief Summary

This is a first in human, non-randomized, open-label, dose escalation study to investigate the safety, pharmacokinetics, immunogenicity and pharmacodynamics of repeat doses of KHK2823.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

  Assessed weekly for duration of treatment (anticipated minimum 8 weeks), plus 42 day follow up period

Secondary Outcomes (4)

• Pharmacokinetics: Peak serum concentration (Cmax) Time to reach Cmax (tmax) Minimum serum concentration (Ctrough) Area under curve (AUC) Half-life (t1/2) Clearance (CL) Volume of distribution (Vd) Accumulation ratio (R)

  Assessed during first 24 weeks of treatment, plus 42 day follow up period

• Disease Response: overall response rate (ORR), overall survival (OS), event-free survival (EFS), relapse-free survival (RFS), progression-free survival (PFS) and disease-free survival (DFS)

  Assessed every 8 weeks for duration of treatment (anticipated minimum 8 weeks), plus 14 day follow up period

• Immunogenicity: anti-KHK2823 antibody

  Assessed every 4 weeks for first 24 weeks of treatment, plus 42 day follow up period

• Pharmacodynamics: CD123+

  Assessed during first 24 weeks of treatment, plus 42 day follow up period

Study Arms (1)

KHK2823

EXPERIMENTAL

single agent KHK2823 administered at selected dose levels

Drug: KHK2823

Interventions

KHK2823 DRUG

single agent KHK2823

KHK2823

Eligibility Criteria

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

You may qualify if:

• Males and females ≥ 18 years old with previously untreated AML who are not candidates for intensive remission induction therapy; relapsed/refractory AML for whom no other standard therapy is available or appropriate; or relapsed/refractory MDS who have received prior therapy with a hypomethylating agent or who are not candidates to receive a hypomethylating agent
• Histopathologically/cytologically documented primary or secondary AML, as defined by WHO criteria, or MDS, confirmed by pathology review at treating institution
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
• Life expectancy of at least 3 months

You may not qualify if:

• Histological diagnosis of acute promyelocytic leukemia (FAB Type M3)
• Clinically significant central nervous system leukemia
• Treatment of the underlying hematologic condition with systemic therapy during the treatment period, including any chemotherapy, radiation or investigational therapy, within 2 weeks prior to KHK2823 administration; or immunotherapy within 30 days prior to KHK2823 administration; with the exception of hydroxyurea (Hydrea®) for treatment of hyperleukocytosis, which must be discontinued at least 24 hours prior to the first dose of KHK2823

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (7)

University of Sussex, Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

St James's Institute of Oncology

Leeds, United Kingdom

Location

NIHR/Wellcome UCLH Clinical Research Facility University College Hospital London

London, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Northern Centre for Cancer Care, Freeman Road Hospital

Newcastle upon Tyne, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 4, 2014
• Study Start: June 1, 2014
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

GB (7)