Intrigue: DCC-2618 vs sunitinib in advanced GIST after treatment with imatinib

There is no translation available.

 

Agents: DCC-2618 (Ripretinib) vs. Sunitinib
Phase III
Status  Closed for recruitment, active
Sponsor

Deciphera Pharmaceuticals LLC

 

Further information: https://clinicaltrials.gov/ct2/show/NCT03673501

 

WHO is the trial for?
  • Patients with confirmed advanced or metastatic GIST
  • Patients must have progressed on imatinib or are intolerant to imatinib; patients who had further lines of treatment after imatinib cannot enter the study
  • Overall health status of the patient has to be good (ECOG performance status 0-2)
  • Archival or fresh tumor tissue sample must be provided

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

This study aims to assess the safety and efficacy of DCC-2618 (ripretinib) vs. sunitinib (Sutent®) in patients with advanced GIST who have been treated with (only) imatinib before and experienced a progression, or are intolerant to imatinib.

DCC-2618 is a so-called KIT and PDGFRa kinase switch control inhibitor. In previous clinical trials in later stages of the disease, it showed a clinical benefit for pre-treated GIST patients. This study aims to confirm the results in earlier lines of therapy.

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 closed for recruitment, but active.

WHERE is the trial available?

The trial is being conducted in several study centers in the US, in Australia, Canada, Italy, the Republic of Korea, Norway, Poland, Singapore, Spain, Taiwan and the UK.
For further information please check here.

Study contact:

  • Contact: Clinical Team
    Tel. 001-785-830-2100
    Email: このメールアドレスはスパムボットから保護されています。閲覧するにはJavaScriptを有効にする必要があります。

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.


Patients in one group will be assigned to DCC-2618 (ripretinib), the other group will receive sunitinib.


DCC-2618 will be given at a dose of 150 mg once daily continuously; patients in the sunitinib arm will receive a dosage of 50 mg once daily for 4 weeks, followed by a break of 2 weeks (6 week cycles: 4 weeks on, 2 weeks off).

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: このメールアドレスはスパムボットから保護されています。閲覧するにはJavaScriptを有効にする必要があります。

SHARE your experience

 You want to share your experience on this trial?
Send us an e-mail to: このメールアドレスはスパムボットから保護されています。閲覧するにはJavaScriptを有効にする必要があります。
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