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Study of Regorafenib in Patients With Advanced Myeloid Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of Regorafenib in Patients With Advanced Myeloid Malignancies

Phase I Study of Regorafenib in Patients With Advanced Myeloid Malignancies

NCT03042689•Massachusetts General Hospital

Summary

This research study is studying a drug as a possible treatment for advanced myeloid malignancies including AML (acute myeloid leukemia), MDS (myelodysplastic syndrome) and MPN (myeloproliferative neoplasms) The intervention involved in this study is: -Regorafenib (Stivarga)

Detailed Description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved Regorafenib for this specific disease but it has been approved for other uses. In this research study, the investigators are looking for the best dose of Regorafenib to treat the participant's disease with. Researchers will also look at how effective the study drug is in treating the participant's disease and if any side effects occur.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of relapsed/refractory advanced malignancies. Specifically: relapsed refractory refractory acute myeloid leukemia that have failed one line of prior therapy, myelodysplastic syndrome that have failed hypomethylating agents, myelofibrosis that have failed ruxolitinib or are ineligible for this therapy.
•18 years of age or greater.
•ECOG performance status of 0-1.
•Able to provide informed consent.
•Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
•Able to swallow and retain oral medication.
•Normal organ and marrow function defined as:
•* Total bilirubin ≤ 1.5 x the upper limits of normal (ULN) except for patients with Gilbert's disease.
•* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer).
•* Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver or bone involvement of their cancer).
+2 more criteria

Exclusion Criteria

•Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study.
•Systemic antineoplastic therapy in the past 14 days (excluding hydroxyurea).
•Uncontrolled hypertension (systolic pressure \>140 mmHg or diastolic pressure \> 90 mmHg on repeated measurement) despite optimal medical management.
•Active or clinically significant cardiac disease including:
•* Congestive heart failure - New York Heart Association (NYHA) \> Class II.
•* Active coronary artery disease.
•* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
•* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
•Evidence or history of bleeding diathesis or coagulopathy.
•Eligible for, have a suitable donor and are willing to undergo Hematopoietic Stem Cell Transplantation (HSCT)
+17 more criteria

Locations (1)

Massachusetts general Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

April 17, 2017

Primary Completion Date

September 1, 2021

Completion Date

February 27, 2023

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Regorafenib

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 8, 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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Study of Regorafenib in Patients With Advanced Myeloid Malignancies

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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