NCT04129151

Palbociclib + Ganitumab In Ewing Sarcoma

Phase 2 Trial of Palbociclib and Ganitumab in Patients With Relapsed or Refractory Ewing Sarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study involves participants taking a medicine that inhibits proteins in cancer cells called CDK4 and CDK6 (palbociclib) in combination with a medicine that inhibits a protein called IGF-1R (ganitumab). This study is designed to see if these drugs are safe when given together and whether they are effective in treating Ewing sarcoma. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or drug combination to learn whether the drug(s) works in treating a specific disease. "Investigational" means that the drug or combination is being studied. The U.S. Food and Drug Administration (FDA) has not approved ganitumab as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has not approved palbociclib for this specific disease but it has been approved for another cancer. This research study is: * Testing whether palbociclib and ganitumab are safe when given together and effective in treating Ewing sarcoma. * Testing markers in the blood and in tumor tissue to see if there are certain features of the tumor that may indicate this combination of drugs is effective or not effective

Conditions

• Ewing Sarcoma
• Ewing's Sarcoma Recurrent

Interventions

Type	Name	Description
DRUG	Palbociclib	Oral, per protocol pre determined dosage, once a day for 21 days
DRUG	Ganitumab	-Intravenous, per protocol predetermined dosage, twice per cycle

Timeline

• Start date: 2019-12-05
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2019-10-16
• Last updated: 2024-08-01
• Results posted: 2024-07-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study