Description:
A Phase 1/2 study of DSP 5336 in patients with relapsed or refractory AML.
A Phase 1/2 study of DSP 5336 in patients with relapsed or refractory AML.
Not yet recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
DSP-5336 | Arm A without Antifungals | |
Antifungals | Posaconazole, variconazole, fluconazole - investigator's choice | Arm B with Antifungals |
A Phase 1 dose escalation FIH study in relapsed or refractory AML/ALL to determine the maximum tolerated dose (MTD) and/or a recommended Phase 2 dose (RP2D) of DSP 5336, followed by a Phase 2 dose-expansion portion to further evaluate the safety and clinical activity of DSP 5336 in relapsed or refractory AML patients with an MLLr and/or NPM1m
Name | Type | Description | Interventions |
---|---|---|---|
Arm A without Antifungals | Other | Patients not taking antifungals within 7 days of study entry |
|
Arm B with Antifungals | Other | Patients taking antifungals at study entry |
|
Inclusion Criteria 1. Have a diagnosis of relapsed or refractory AML or ALL for Phase I and for Phase 2 have a diagnosis of relapsed or refractory AML with MLLr or NPM1 2. Be > /= 18 years of age or 20 years if required by local regulation 3. ECOG < /= 2 4. WBC below 30,000/μL (hydroxyurea allowed) 5. Glomerular filtration rate (GFR) ≥ 50 ml/min, assessed by the Cockcroft-Gault formula 6. Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome) 7. Aspartate aminotransferase (AST) ≤3.0 times ULN 8. Alanine aminotransferase (ALT) ≤3.0 times ULN Exclusion Criteria: 1. Has a left ventricular ejection fraction (LVEF) <45%, as determined by ECHO 2. Histological diagnosis of acute promyelocytic leukemia 3. Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP 5336 4. Has had abnormal ECGs that are clinically significant, such as QT prolongation (QTc >450 msec for males and >470 msec for females, with QTc corrected according to Fridericia's formula [QTcF]) 5. Has an active, uncontrolled, bacterial, viral, or fungal infection requiring systemic therapy 6. Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4/5, including specifically: ketoconazole, itraconazole and isavuconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Assess the safety and tolerability of DSP-5336 in relapsed/refractory AML or ALL |
Time Frame: | Approximately 2 months after first dose |
Safety Issue: | |
Description: | Occurrence of DLTs and frequency, duration and severity of TEAEs and SAEs assessed by NCI CTCAE v 5.0 |
Measure: | Preliminary clinical activity of DSP-5336 in adult patients with AML or ALL |
Time Frame: | Approximately 6 months after first dose |
Safety Issue: | |
Description: | Disease response as assessed by ELN 2017 criteria |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Sumitomo Dainippon Pharma Oncology, Inc |
August 9, 2021