Acute Myeloid Leukemia Clinical Trial
A Study of PRT1419 Injection in Patients With Relapsed/Refractory Hematologic Malignancies
This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with relapsed/refractory hematologic malignancies. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.
This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients as part of a 28-day treatment cycle in adult patients with acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), high-risk myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) overlap syndrome. The study will employ a "3+3" dose escalation design. The dose may be escalated until a minimum safe and biologically effective dose or MTD is reached.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2
Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
Left ventricular ejection fraction of ≥ 50%
All patients must have recovered from the effects of any prior cancer related therapy, radiotherapy, or surgery (toxicity no greater than Grade 1).
All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 14 days, whichever is longer before enrollment into the trial, and until any toxicities of the prior investigational agent have resolved to Grade 1 or a baseline state
Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial
AML patients only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification and patients with targeted mutations must have been treated with appropriate therapy for their disease
a. White blood cell count < 25 × 10^9/L. Hydroxyurea or leukapheresis are permitted to meet this criterion
CMML patients only: intermediate-2 or high risk per CMML-specific prognostic scoring system (CPSS) or clinical/molecular CPSS (CPSS-mol) criteria. Must have failed at least 4-6 cycles of prior therapy with a hypomethylating agent
High Risk MDS - MDS/MPN Overlap Syndrome: intermediate, high, or very high risk by International Prognostic Scoring System-Revised [IPSS-R] criteria that is relapsed or refractory to approved therapies, including at least 4-6 cycles of a hypomethylating agent, or MDS/MPN Overlap Syndrome (displaying both fibrosis and dysplastic features)
Known hypersensitivity to any of the components of PRT1419
Female patients who are pregnant or lactating
Active inflammatory disorders of the gastrointestinal tract, or patients with GI malabsorption
Mean QTcF interval of > 480 msec
History of heart failure, additional risk factors for arrhythmias or requiring concomitant medications that prolong the QT/QTc interval
Elevated cardiac troponin or evidence of recent cardiac injury
HIV positive; known active hepatitis B or C
Hematopoietic stem-cell transplantation within the last 90 days or have GVHD Grade > 1 at study entry
Uncontrolled intercurrent illnesses
Treatment with either OATP1B1, OATP1B3 substrates or strong inhibitors of CYP2C8
Prior exposure to an MCL1 inhibitor
History of another malignancy except for:
Malignancy treated with curative intent with no known active disease for > 2 years prior to study start
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Other concurrent low-grade malignancies (i.e., chronic lymphocytic leukemia (CLL) (Rai 0)) may be considered after consultation with Sponsor
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There are 8 Locations for this study
Orange City Florida, 32763, United States
Orlando Florida, 32804, United States
Bethesda Maryland, 20817, United States
Brick New Jersey, 08724, United States
Port Jefferson Station New York, 11776, United States
Canton Ohio, 44718, United States
Philadelphia Pennsylvania, 19107, United States
Houston Texas, 77030, United States
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