Navigator: Avapritinib (BLU-285)


NAVIGATOR: Avapritinib (BLU-285)

Phase I study of Avapritinib (formerly BLU-285) in patients with GIST and other relapsed/refractory solid tumors (Navigator).

Trial name: Navigator
Agents: Avapritinib (formerly BLU-285)
Phase I
Status  Open, recruiting
Sponsor Blueprint Medicines Corporation

Further information: https://www.clinicaltrials.gov/ct2/show/NCT02508532?term=NCT02508532&rank=1

WHO is the trial for?

  • Patients with GIST that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib, or an experimental tyrosine kinase inhibitor (TKI) agent, and the patient does not have a D842 mutation in PDGFRα
  • Patients with a confirmed diagnosis of unresectable GIST with a D842V mutation in the PDGFRα gene
  • Patients with GIST that has progressed and/or patients who have experienced intolerance to imatinib and have not received additional TKI therapy
  • Overall health status of the patient has to be good (ECOG performance status 0-2)

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

This study assesses the safety and tolerability, but also the efficacy of avapritinib (BLU-285) in patients with unresectable GIST. This includes patients with a D842V mutation in the PDGFRA gene or those without that mutation which have progressed under at least two different TKI inhibitors.

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 GIST and potentially help other patients with this disease. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open (recruiting)

WHERE is the trial available?

The trial is available in several study centers in the US, Belgium, France, Germany, Korea, the Netherlands, Spain and the UK. Poland and Italy will open study centers soon. For further information please check here.

Study contact:
Blueprint Medicines
Phone: +1-617-714-6707
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

STUDY DESIGN: What does the study look like?

This study just contains one arm: All patients receive the study drug avapritinib (BLU-285). However, the study consists of 2 parts: Part 1 evaluates the dosage in which avapritinib should be given (completed), part 2 the efficacy of the drug.

In part 2 there are three different groups (cohorts) being evaluated: patients with PDGFRA D842V-mutant GIST, patients with GIST who received imatinib and at least one other drug and patients who don't tolerate imatinib or have progressed on it and did not receive any other kind of therapy.

SPAEN Study Registry AvapritinibBLU phaseI

 

HOW do I get more information?

Patient organisations supporting GIST and/or sarcoma 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: This email address is being protected from spambots. You need JavaScript enabled to view it.

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

Latest published results were presented during the Annual Conference of the Connective Tissue Oncology Society (CTOS) in November 2017 and can be viewed here.

 

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.

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