A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas

Phase 2 Completed 42 enrolled Massachusetts General Hospital Dana-Farber Cancer Institute · collab PharmaMar · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research study is investigating a drug called PM01183 alone and in combination with chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic or unresectable Sarcoma.

Timeline

Start: 2015-08
Primary completion: 2017-02
Completion: 2019-04-01

Outcome

Mixed primary results

paper StrB did not continue to the second stage. PMID 31896519 ↗

paper In StrC, no patients met the primary end-point. PMID 31896519 ↗

paper The combination of lurbinectedin/doxorubicin reached the DCR end-point with seven PR and one patient with SD PMID 31896519 ↗

Publications

Cote GM, Choy E, Chen T, Marino-Enriquez A, Morgan J, Merriam P, Thornton K, Wagner AJ, Nathenson MJ, Demetri G, George S. A phase II multi-strata study of lurbinectedin as a single agent or in combination with conventional chemotherapy in metastatic and/or unresectable sarcomas. Eur J Cancer. 2020 Feb;126:21-32. doi: 10.1016/j.ejca.2019.10.021. Epub 2019 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	—	Intravenous
Subject	Gemcitabine	Small molecule	—	Intravenous
Subject	Lurbinectedin	Other / unclassified	—	Intravenous