invictus: DCC-2618 vs. placebo in advanced pre-treated GIST patients

 

Agents: DCC-2618 vs. placebo
Phase III
Status  Open, recruiting
Sponsor

Deciphera Pharmaceuticals LLC

 

Further information: https://clinicaltrials.gov/ct2/show/NCT03353753

 

WHO is the trial for?

  • Patients with confirmed advanced or metastatic GIST with all types of mutation in KIT or PDGFRa (excluded are patients without KIT or PDGFRa mutations)
  • Patients must have progressed on imatinib, sunitinib, and regorafenib or do not tolerate any of these treatments
  • 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 aims to assess the safety and efficacy of DCC-2618 in patients with advanced GIST who have been treated with other anticancer therapies – incl. imatinib, sunitinib, regorafenib – before.

DCC-2618 is a so-called KIT and PDGFRa kinase switch control inhibitor. In pre-clinical studies, it has shown activity against all known initiation and resistance KIT mutations. This clinical trial tries to confirm this in clinical practice.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy and 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. For more about the importance and benefits of joining clinical trials, please click here.

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, Australia, Belgium, the UK, Singapore, Canada, Spain, Poland, France and Finland. Further centers are planned to open in Germany, Italy and the Netherlands. For further information please contact the company (contact details below) or check here.

Study contact:

  • Contact: Clinical Team Invictus
    Tel. 001-781.209.6400
    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?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Two thirds of the patients will be assigned to DCC-2618, the other group (one third of the patients) will receive placebo.

Patients, who might progress on placebo can receive/cross-over to the DCC-2618 arm.

SPAEN Study Registry DCC2618 invictus

 

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.

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: List of organisations worldwide.

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

No results are available at this time. Future results will be linked 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.

Merken