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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Completed PHASE1 INTERVENTIONAL NCT01379287

Dose-Escalation Safety and Pharmacokinetic Study of Iso-Fludelone in Patients With Advanced Solid Tumors

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Iso-fludelone is a type of chemotherapy drug called an epothilone. Epothilones are drugs that attach to proteins in your body called "tubulins". Tubulins help cells to grow, and are found in both normal and cancer cells. When research animals with cancer were given the study drug, Iso-fludelone, the drug attached itself to "tubulin" and slowed or stopped the cancer cells from growing. Other types of epothilones have been tested in cancer patients and were found to be safe. A similar epothilone drug and other drugs called taxanes are currently approved by the FDA for treating certain types of cancers. The purpose of this study is to see the effects, good and/or bad, of this investigational drug, Iso-fludelone, on cancer. The term "investigational" means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA) or other regulatory agencies. This study is the first time the investigators are using iso-fludelone in people. This is a Phase I study. In a Phase I study, the first people to receive the drug are given a fairly low dose.

Interventions

Name: Iso-Fludelone
Type: DRUG
Description: Iso-fludelone will be administered IV over 6 hours (+/- 30 mins) on Day 1 of every 3 week cycle.

Primary Outcomes

Measure: To determine the maximum tolerated dose (MTD)
TimeFrame: 2 years
Description: The MTD is defined as the dose that results in DLT in 25% of all evaluable patients.
Measure: To determine the dose limiting toxicity (DLT), safety
TimeFrame: 2 years
Description: Toxicities and adverse events will be assessed using the NCI CTC version 4.0

Trial Information

NCT ID

NCT01379287

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Memorial Sloan Kettering Cancer Center

Last Updated

December 15, 2025