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Epothilone

Iso-Fludelone for Solid Tumors

Phase 1

Waitlist Available

Led By Mrinal Gounder, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

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 2 years

Awards & highlights

Study Summary

This trial will test the safety of Iso-fludelone and see what effects, good and/or bad, it has on different types of cancer cells.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the dose limiting toxicity (DLT), safety

To determine the maximum tolerated dose (MTD)

Secondary outcome measures

To describe and assess any preliminary evidence of anti-tumor activity of iso-fludelone

To evaluate the plasma pharmacokinetics of iso-fludelone when administered intravenously

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Advanced Solid TumorsExperimental Treatment1 Intervention

The trial was initially designed as a 3 hour IV infusion of iso-fludelone every 3 weeks with three dose-escalation stages (12 patients), however it has been amended to study iso-fludelone administered over 6 hours (+/- 30 minutes) every 3 weeks schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iso-Fludelone

2011

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,869 Total Patients Enrolled

University of PittsburghOTHER

1,722 Previous Clinical Trials

16,342,917 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,640 Previous Clinical Trials

4,129,435 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have opted to participate in this clinical experiment?

"At this time, recruitment for the trial has concluded. This medical trial was initially posted on June 1st 2011 and last updated on June 7th 2022. In addition to this study, there are currently 2585 cancer-focused trials looking for participants as well as a single Iso-Fludelone related research project recruiting patients."

Answered by AI

Are any participants currently enrolling in this research endeavor?

"Unfortunately, recruitment for this clinical trial has finished. Initially posted on June 1st 2011 and last edited on July 6th 2022, those looking to participate in a study will have to look elsewhere. At the moment there are 2585 trials recruiting cancer patients and one actively accepting participants into an Iso-Fludelone research program."

Answered by AI

To what degree can Iso-Fludelone be detrimental to human health?

"As this is a Phase 1 trial, with limited evidence of efficacy and safety, our team at Power have assigned Iso-Fludelone a score of 1 on their risk assessment scale."

Answered by AI

Have prior trials used Iso-Fludelone to evaluate medical efficacy?

"Presently, 1 trial is actively investigating Iso-Fludelone with 0 in Phase 3. Multiple locales across New york are facilitating research on this drug while one specific site is running trials for it exclusively."

Answered by AI

Has this type of clinical trial been conducted before or is it a pioneering effort?

"Currently, Bristol-Myers Squibb's Iso-Fludelone is undergoing a single clinical trial across one city and country. This marks the first evaluation of this medication since 2011 when it completed Phase 1 drug approval with 29 participants. Since then, no new trials have been launched."

Answered by AI

Recent research and studies

Journal of Pharmaceutical and Biomedical AnalysisJournal

Quantitative Method for the Determination of Iso-fludelone (KOS-1803) in Human Plasma by LC–MS/MS

Christner, Susan M., Robert A. Parise, Erica D. Levine, Naiyer A. Rizvi, Mrinal M. Gounder, and Jan H. Beumer. 2014. “Quantitative Method for the Determination of Iso-fludelone (KOS-1803) in Human Plasma by LC–MS/MS”. Journal of Pharmaceutical and Biomedical Analysis. Elsevier BV. doi:10.1016/j.jpba.2014.08.007.

clinicaltrials.govStudy

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

2011. "Dose-Escalation Safety and Pharmacokinetic Study of Iso-Fludelone in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01379287.