Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

14-O-phosphonooxymethyltriptolide disodium salt

Antineoplastic Agents, Alkylating

Alkylating Agents

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

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days.

Minnelide™ 001

Mohana Velagapudi, MD

Linda Vocila, BSN

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

This is a Phase 1, open label, multicenter, dose-escalation study of safety, pharmacokinetics, and pharmacodynamics of Minnelide™

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Dose escalation will follow a modified Fibonacci design.

Study of Minnelide™ in Patients With Advanced GI Tumors

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.

The MTD will be determined using a 3 + 3 design and will continue until 2 patients at any dose level experience a DLT. A DLT will be defined as Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection;Grade 4 thrombocytopenia (or Grade 3 with bleeding);Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \> 72 hours despite maximal treatment constitutes a DLT, insufficient treatment will not constitute an exception to the DLT criteria, as this would constitute inadequate conduct of the study); Dosing delay greater than 2 weeks due to treatment-emergent AEs or related severe laboratory abnormalities.

Once the MTD has been determined this will be the dose going forward in phase 2 studies

Plasma concentration data will be used to determine the following PK parameters:

* AUC Area under the concentration curve
* Cmax Maximum plasma concentration
* Tmax Time to maximum plasma concentration
* t1/2 Terminal phase half life
* CL/F Total body clearance
* Vd/F Apparent volume of distribution

Objective measurements of tumor size will be recorded from PET, CT scan and other measures.

As part of exploratory PD, the following assessments will be performed:

* Biomarkers including CA19-9 (or CA125, CEA if non-secretors for pancreas cancer), CEA and CA125 as applicable, any tumor marker appropriate to the given cancer or that is known to be elevated in a given patient will be evaluated according the Investigator's discretion, prior to every Cycle.
* Serum HSP70 levels
* PET Scans
* Evaluation of CT scans using Choi criteria

Minneamrita Therapeutics LLC

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients, examined by endoscopy, being screened for GI tract tumors

no intervention

Arie Orenstein, Prof.

Gidi Arbel, Dr.

Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Minnelide™ in Patients With Advanced GI Tumors	NCT01927965	Advanced Gastro...	Minnelide™ 001	18 Years -	Minneamrita Therapeutics LLC
Measuring Temperatures of Tissues During Endoscopy	NCT00868504	Carcinoma, Undi...	no intervention	18 Years -	Sheba Medical Center
Measuring Temperatures of Tissues During Endoscopy	NCT00868504	Carcinoma, Undi...	no intervention	18 Years -	Sheba Medical Center

Spots Global Cancer Trial Database for gi tract

Every month we try and update this database with for gi tract cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gi tract

Every month we try and update this database with for gi tract cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gi tract cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.