NCT01379287

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

Completed Phase 1 Last updated 2 February 2023

What this trial tests

Phase 1 trial testing Iso-Fludelone in Solid Tumors in 29 participants. Completed in 31 January 2023.

Timeline

20 June 2011

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	20 June 2011
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Iso-Fludelone — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytoskeletal Proteins in Cancer and Intracellular Stress: A Therapeutic Perspective.
   Ong MS, Deng S, Halim CE, Cai W, et al · · 2020 · cited 90× · PMID 31963677 · DOI 10.3390/cancers12010238
2. Quantitative method for the determination of iso-fludelone (KOS-1803) in human plasma by LC-MS/MS.
   Christner SM, Parise RA, Levine ED, Rizvi NA, et al · · 2014 · cited 1× · PMID 25168219 · DOI 10.1016/j.jpba.2014.08.007