Trials / Terminated
TerminatedNCT02181699
Study of KHK2823 in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Phase 1 Study of KHK2823 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Kyowa Kirin, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase 1, multi-center, open-label, dose-escalation study of KHK2823 in adult patients 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, such as decitabine and azacitidine or who are not candidates to receive a hypomethylating agent, this would include high risk or transfusion-dependent low risk patients. Patients must have documented primary or secondary AML or MDS according to World Health Organization (WHO) criteria. Following the provision of signed informed consent, patients will be screened for entry into the study. The study consists of 2 parts. In Part 1, 3 to 6 patients per cohort will be enrolled sequentially in up to 7 dose-escalation cohorts to establish the MTD. KHK2823 will be administered once weekly. In Part 2, up to an additional 18 patients may be enrolled to further evaluate the safety, PK, PD, potential anti-leukemic activity of KHK2823.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK2823 | single agent KHK2823 |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2019-05-10
- Completion
- 2019-05-10
- First posted
- 2014-07-04
- Last updated
- 2024-04-29
Locations
7 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02181699. Inclusion in this directory is not an endorsement.