Trial Title:
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
NCT ID:
NCT05546580
Condition:
Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Gilteritinib
Conditions: Keywords:
Acute Myeloid Leukemia, FLT3 mut
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Escalation/extension open label study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iadademstat
Description:
iadademstat oral solution
Arm group label:
Active arm
Other name:
ORY-1001, RO7051790
Intervention type:
Drug
Intervention name:
Gilteritinib Oral Tablet
Description:
120 mg Gilteritinib
Arm group label:
Active arm
Other name:
XOSPATA®
Summary:
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory
Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+).
During the trial, iadademstat will be given in combination with gilteritinib, a drug that
is already approved to treat patients with FLT3-mutated R/R AML.
Detailed description:
This is an escalation/expansion, open label, single arm, study to investigate the safety
and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML.
This study consists of 2 parts. A dose finding part to evaluate the safety, tolerability,
pharmacokinetic (PK), pharmacodynamic (PD) and emerging activity of iadademstat and
gilteritinib combination, and to determine the pharmacologically-active dose (i.e., the
minimum safe and biologically active dose) of iadademstat in combination with
gilteritinib, and an expansion part at the specific dose/s selected to evaluate the
activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated
R/R AML.
Criteria for eligibility:
Criteria:
Main Inclusion Criteria:
- Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)
- Patient is in first or second relapse or has refractory disease. Patients must have
had histologic verification of AML at the original diagnosis.
- Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3
internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or
FLT3-ITD and specified FLT3-TKD.
- ECOG performance status 0-2
- Life expectancy of at least 3 months in the opinion of the investigator.
- Normal hepatic and renal function.
- Patient is able to swallow oral medications.
- Female patients are postmenopausal, documented as surgically sterile, use two
methods of contraception or practice true abstinence and have a negative urine
pregnancy test at screening.
- Male patients even if surgically sterilized agree to practice true abstinence or use
highly effective barrier contraception.
Main Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia.
- Known BCR-ABL-positive leukemia.
- AML secondary to prior chemotherapy for other neoplasms (except for MDS).
- AML that has relapsed after or is refractory to more than 2 lines of therapy.
- Clinically active central nervous system leukemia or prior history of NCI CTCAE
Grade ≥ 3 drug-related CNS toxicity.
- Major surgery or radiation therapy within 4 weeks prior to the first study dose.
- Prior treatment with iadademstat is not allowed. Treatment with any other agents
with KDM1A/LSD1 inhibitory activity is only allowed if treatment finalized at least
3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is
allowed in the following cases: midostaurin and sorafenib are allowed when used in
first-line therapy regimen as part of induction, consolidation and/or maintenance:
quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as
part of induction, consolidation and/or maintenance, ONLY if patients were not
refractory to the drugs or if responding, relapse did not occur while on these
drugs.
- Patients not eligible to receive gilteritinib per label.
- Prior treatment with 3 or more lines of AML therapy.
- Treatment with any investigational products within 3 weeks prior to first dose of
study treatment.
- Uncontrolled hypertension or poorly controlled diabetes.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rajneesh Nath, MD
Phone:
+34 935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
The University of Arizona Cancer Center - North Campus
Address:
City:
Tucson
Zip:
85724-5024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sharad Khurana, MD, MSc
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Investigator:
Last name:
Sharad Khurana, MD
Email:
Principal Investigator
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sangeetha Venugopal, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guenther Koehne, MD, PhD
Phone:
+34 935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
The John Hopkins University School of Medicine
Address:
City:
Baltimore
Zip:
21287-0013
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander J Ambiender, MD
Phone:
+34 935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Massachusetts General Hospital (MGH)
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amir Fathi, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Rutgers, The State University
Address:
City:
Piscataway
Zip:
08854
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil D Palmisiano, MD, MS
Phone:
+34 935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Feld, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Harry P Erba, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theodore P Braun, MD PhD
Phone:
+34 935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Sarah Cannon Research Institute, LLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen Strickland, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
West Virginia University
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Contact:
Last name:
Konstantinos Sdrimas, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Facility:
Name:
Froedtert Hospital & The Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guru SG Murthy, MD
Phone:
+34935151313
Email:
FRIDA_queries@oryzon.com
Start date:
November 14, 2022
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Oryzon Genomics S.A.
Agency class:
Industry
Source:
Oryzon Genomics S.A.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546580
