Palbociclib + Ganitumab In Ewing Sarcoma

Phase 2 Terminated 10 enrolled Dana-Farber Cancer Institute 1 Million 4 Anna Foundation · collab Alan B. Slifka Foundation · collab Carson Sarcoma Foundation · collab ChemoWarrior: the eli sidler foundation · collab Rutledge Cancer Foundation · collab Teaming up to Fight Childhood Cancer · collab i-ROK Foundation · collab

NaSingle-groupOpen-labelTreatment

Summary

This research study is designed to study the combination of two drugs, palbociclib and ganitumab, as a potential treatment for Ewing sarcoma. The names of the study drugs involved in this study are: * Palbociclib * Ganitumab

Timeline

Start: 2019-12-05
Primary completion: 2022-12-15
Completion: 2022-12-15

Outcome

Missed primary endpoint

Stopped: “The study closed early due to discontinuation of ganitumab supply.”

paper There were no complete or partial responders. PMID 37306107 ↗

paper This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease. PMID 37306107 ↗

Publications

Results Shulman DS, Merriam P, Choy E, Guenther LM, Cavanaugh KL, Kao PC, Posner A, Bhushan K, Fairchild G, Barker E, Klega K, Stegmaier K, Crompton BD, London WB, DuBois SG. Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma. Cancer Med. 2023 Jul;12(14):15207-15216. doi: 10.1002/cam4.6208. Epub 2023 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ganitumab	Monoclonal antibody	18 mg/kg	Intravenous
Subject	Palbociclib	Small molecule	100 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral