Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

Phase 1 Terminated 35 enrolled Alaunos Therapeutics Memorial Sloan Kettering Cancer Center · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease. It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.

Timeline

Start: 2010-04-06
Primary completion: 2012-09-03
Completion: 2013-05-21

Outcome

Outcome not reported

Stopped (Enrollment): “Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.”

Publications

Kapoor S, Srivastava S, Panda D. Indibulin dampens microtubule dynamics and produces synergistic antiproliferative effect with vinblastine in MCF-7 cells: Implications in cancer chemotherapy. Sci Rep. 2018 Aug 17;8(1):12363. doi: 10.1038/s41598-018-30376-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	indibulin	Small molecule	—	Oral