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Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia

Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia

NCT03760523•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This study is to determine the safety and recommended dosing of Minnelide in Acute Myeloid Leukemia (AML)

Detailed Description

This phase 1 dose escalation clinical trial will establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Minnelide as single-agent in relapsed/refractory (R/R) acute myeloid leukemia (AML) patients who are ineligible to receive intensive chemotherapy. The oral formulation of Minnelide will be used. Minnelide is a prodrug of triptolide (a potent heat shock protein (HSP) 70 inhibitor) with promising preclinical activity in AML.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults ages 18 years or older.
•Participant must have relapsed or refractory acute myeloid leukemia (AML) (excluding acute promyelocytic leukemia).
•Relapsed patients must have received at least 1 induction chemotherapy regimen or two cycles of a hypomethylating agent and achieved a Complete Response (CR), followed by relapse of disease.
•Refractory patients must have received at least 1 induction chemotherapy regimen or two cycles of hypomethylating agent without achieving a CR.
•Eastern Cooperative Oncology Group (ECOG) performance status \<2.
•Participants must have acceptable organ function.
•Be able and willing to adhere to the study visit schedule and other protocol requirements.
•Must be able to swallow capsules and have no evidence of GI tract abnormality that would alter the absorption of oral medications.
•The effects of Minnelide on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment.
•Participants of childbearing potential must practice contraception. Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Male participants with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
+2 more criteria

Exclusion Criteria

•Participants may not have received any therapy with any investigational products, systemic anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1 Day 1. Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea during protocol treatment.
•Candidates for standard and/or potentially curative treatments.
•Major surgery within 28 days prior to Cycle 1 Day 1.
•New York Heart Association Class III or IV heart failure, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on an electrocardiogram (EKG)
•Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
•Known, active HIV, Hepatitis A, B or C infection (prior Hepatitis C infection that has been treated and determined to be cured is allowed)
•Symptomatic central nervous system (CNS) involvement with leukemia
•A concurrent second active and non-stable malignancy with the exception of non-melanoma skin cancer or carcinoma in-situ.

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

April 18, 2019

Primary Completion Date

October 9, 2023

Completion Date

October 9, 2023

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Minnelide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

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