Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Ewing Sarcomas

Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors incl. Ewing Sarcomas (phase II)

Agents: Combination with irinotecan and temozolomide with or without palbociclib
Phase II
Status Closed for recruitment, but active
Sponsor Pfizer

Further information: https://clinicaltrials.gov/ct2/show/NCT03709680

This study is comparing the effectiveness of the study medicine palbociclib when taken in combination with chemotherapy medicines irinotecan (IRN) and temozolomide
(TMZ) versus chemotherapy alone for the treatment of Ewing sarcoma (phase II).

Phase I of the study has already closed. This description refers to phase II of the study.

WHO is the trial for?
  • Patients with Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement
  • Patients must be between the ages of 2 – 20 years old
  • Overall health of the patient must be good (ECOG performance status of 0 or 1

WHAT is the key question that this trial is attempting to answer?

 This study aims to investigate a drug called palbociclib and is comparing the effectiveness of palbociclib when taken in combination with chemotherapy medicines irinotecan (IRN) and temozolomide (TMZ) versus chemotherapy alone for the treatment of Ewing sarcoma (phase II).

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 Phase II of this study is closed for recruitment, but active.

WHERE is the trial available?

 The trial is being conducted in several study centers in the US, Canada, Hungary, India, Korea, Poland, Slovakia, Sweden, Turkey. For further information please check here: https://clinicaltrials.gov/ct2/show/NCT03709680
Study contact: Pfizer CT.gov, Call Center 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

STUDY DESIGN: What does the study look like?

 This study has two arms: Patients will be randomly assigned to receive the study medicine palbociclib in combination with IRN and TMZ, or IRN and TMZ alone. Patients are twice as likely to receive palbociclib than not. In addition, participants will know what treatment they have been assigned to receive.

The study medicines are taken in 21-day treatment cycles. The number of treatment cycles completed will vary for everyone. Participants may continue receiving treatment for as long as it is of benefit to them.

 

HOW do I get more information?

 Patient organisations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

CONNECT with other patients on this trial

 If you want to connect with other patients considering or participating in this trial, you can find them here.

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.eu
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 Not yet available.

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken