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Anti-tumor antibiotic

Minnelide for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Kendra L Sweet, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study Summary

This trial is to find a safe dose of Minnelide for people with Acute Myeloid Leukemia.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of Minnelide

Number of Participants Who Experience Dose Limiting Toxicities (DLTs)

Secondary outcome measures

Complete Response (CR)

Overall Response Rate (ORR)

Overall Survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Minnelide Dose EscalationExperimental Treatment1 Intervention

A 3+3 design will be used. The first 3 patients will be treated at dose level 1. If none experience a Dose Limiting Toxicity (DLT), the next 3 patients will be treated at dose level 2. If a DLT is observed in 1 out of 3 patients at dose level 1, up to an 3 more patients will be enrolled and treated at that dose level. If 2 patients at dose level have DLTs, dosing will be lowered to dose level -1 (.5 mg daily, taken orally). If 2 or more of the up to 6 patients at any dose level have DLTs, the preceding dose will be declared the Maximum Tolerated Dose (MTD). If more than 1 DLT occurs at Dose Level -1, the investigators will consider stopping the study. Once the MTD has been established, an additional 10 patients will be enrolled at this level to better characterize safety and tolerability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Minnelide

2017

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,465 Total Patients Enrolled

Minneamrita Therapeutics LLCIndustry Sponsor

6 Previous Clinical Trials

202 Total Patients Enrolled

Kendra L Sweet, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

1 Previous Clinical Trials

22 Total Patients Enrolled

Media Library

Minnelide (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03760523 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Minnelide Dose Escalation

Acute Myeloid Leukemia Clinical Trial 2023: Minnelide Highlights & Side Effects. Trial Name: NCT03760523 — Phase 1

Minnelide (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03760523 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes are researchers hoping to uncover through this investigation?

"This clinical trial seeks to identify the Maximum Tolerated Dose (MTD) of Minnelide, with a 28 day window per dosing cohort. The secondary objectives are measuring Participants who experience Complete Response (CR) and Complete Response with Incomplete Blood Count Recovery (CRi), Overall Survival (OS), and Overall Response Rate (ORR)."

Answered by AI

Is this trial actively accepting new participants?

"Affirmative. Data found on clinicaltrials.gov attests to the current recruitment of patients for this trial, which was first posted April 18th 2019 and most recently updated November 2nd 2022. 28 participants are needed from 1 medical facility."

Answered by AI

Has the FDA permitted the use of Minnelide?

"Since Minnelide is still in its first phase of testing, with little evidence that it can be both safe and effective, the safety rating given was 1."

Answered by AI

What is the most robust participant count for this trial?

"Affirmative, the information available on clinicaltrials.gov suggests that this survey is actively seeking participants. It was initially launched on April 18th 2019 and has been updated as recently as November 2nd 2022. The research requires 28 volunteers from a single facility to take part in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03760523.