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Anti-tumor antibiotic
Study of Minnelide™ in Patients With Advanced GI Tumors
Phase 1
Waitlist Available
Research Sponsored by Minneamrita Therapeutics LLC
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 24 months
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol
Eligible Conditions
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™
To establish the dose of Minnelide™ recommended for future phase 2 protocol
Secondary study objectives
To determine pharmacodynamic effect of Minnelide™ on HSP70 levels. And to explore pharmacodynamics effect of Minnelide™ on PET Scans and using Choi criteria on the CT scans.
To determine the pharmacokinetics of Minnelide™
To observe patients for any evidence of antitumor activity of Minnelide™ per RECIST criteria
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Minnelide™ 001Experimental Treatment1 Intervention
A Phase 1, Multi-Center, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ given daily for 21 days followed by 7 days off schedule in patients with Advanced GI Tumors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minnelide™ 001
2013
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Minneamrita Therapeutics LLCLead Sponsor
6 Previous Clinical Trials
184 Total Patients Enrolled
Mohana Velagapudi, MDStudy DirectorMinneamrita Therapeutics LLC
Linda Vocila, BSNStudy DirectorTranslational Drug Development