TRIAL DETAIL

POETIG Trial - POnatinib After rEsisTance to Imatinib in GIST (POETIG)

Drug:
Trial Name:
POETIG Trial - POnatinib After rEsisTance to Imatinib in GIST (POETIG)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Unknown
Phase:
2
Start Date 03/22/2017
Age of Trial (yrs) 8
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI)
Strategy:
Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
POETIG
Sponsor:
Sebastian Bauer
Patient Contact:
Johanna Falkenhorst +49 201 723 84150 johanna.falkenhorst@uk-essen.de
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Purpose:
This is a non-randomized, open-label, multicenter phase 2 study to evaluate the efficacy and safety of ponatinib in patients with metastatic and/or unresectable GIST after prior failure or intolerability of imatinib. Patients will be enrolled into 1 of 2 cohorts based on absence (Cohort A) or presence (Cohort B) of KIT exon 13 resistance mutations as measured by liquid biopsy. A third cohort (Cohort C) will include patients who have received all approved lines of TKI treatments (imatinib, sunitinib and regorafenib).

Inclusion/Exclusion
Patients should check the NCT record for criteria:

Exclusion criteria:

Patients lacking primary mutations of KIT or PDGFRA (including Succinate-Dehydrogenase(SDH)-deficient GIST)

Sponsors and collaborators include:

Hannover Medical School
Helios Klinikum Berlin
University Hospital Tuebingen
Universitätsmedizin Mannheim
University Hospital, Aachen
Helios Klinikum Bad Saarow

Trial Links

Trial Results

Drug Information
Novel agent ponatinib shows promise in resistant CML
 
OncologySTAT - Aug, 6th, 2012 - Ariad prepares for early launch of CML drug ponatinib (may require registration to view article)
 
Ponatinib is active against imatinib-resistant mutants of FIP1L1-PDGFRA and KIT, and against FGFR1-derived fusion kinases
 
Ponatinib - Ariad homepage
 
Ponatinib prescribing information (PDF)
 
ARIAD PASS program - Patient support program, helps patients to access, afford and adhere (to) medications
 
ASCO -2013 - Use of ponatinib to inhibit kinase mutations associated with drug-resistant GIST (abstract) - First author, Michael Heinrich
 
AACR 2013 - Ponatinib,potently inhibits key activating and drug-resistant KIT mutants found in GIST
 
ARIAD Announces Temporary Suspension of Iclusig Marketing in the United States Read more: ARIAD Announces Temporary Suspension of Iclusig Marketing in the United States - FierceBiotech http://www.fiercebiotech.com/press-releases/ariad-announces-temporary-suspension-iclusig-marketing-united-states#ixzz2jKdT3Fwo ARIAD Announces Temporary Suspension of Iclusig Marketing in the United States
 
FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales
 
Ponatinib Inhibits Polyclonal Drug-Resistant KIT Oncoproteins and Shows Therapeutic Potential in Heavily Pretreated Gastrointestinal Stromal Tumor (GIST) Patients (full text)
 

Trial Sites

Name
Address
City
State
Zip
Country
Hufelandstr. 55
Essen
45122
Germany