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POETIG Trial - POnatinib After rEsisTance to Imatinib in GIST

NCT03171389 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-05-31

No results posted yet for this study

Summary

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).

Conditions

  • GIST, Malignant
  • KIT Exon 13 Mutation
  • KIT Gene Mutation

Interventions

DRUG

Ponatinib 30 MG

Ponatinib: once-daily oral dose of 30mg. A cycle of treatment is defined as 28 days. Doses may be reduced to manage drug-related adverse events and may be re-escalated once events resolve.

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • Helios Klinikum Berlin-Buch

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • University Hospital, Aachen

    collaborator OTHER

  • Helios Klinikum Bad Saarow

    collaborator UNKNOWN

  • WiSP GmbH

    collaborator OTHER

  • Sebastian Bauer

    lead OTHER

Principal Investigators

  • Sebastian Bauer, Prof. Dr. · University Hospital, Essen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2018-09-22
Completion
2020-09-22
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171389 on ClinicalTrials.gov