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Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors

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Trial Information

Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group

Inclusion Criteria


Eligibility Criteria:

- Metastatic and/or locally advanced GIST, with diagnosis based on histology with
positive c-kit and/or DOG-1, or with a GIST-typical mutation in KIT or PDGFR

- Measurable disease on CT (computed tomography) as defined by RECIST criteria; at
least one measurable lesion not given radiotherapy

- History of progressive disease on CT according to RECIST criteria after both imatinib
and sunitinib treatment, and also after nilotinib if this drug has been given

- No other TKIs given than imatinib, sunitinib and nilotinib

- Age at least 18 years at the time of diagnosis of GIST

- WHO performance status 0-2

- Resolution of all toxic side effects from earlier TKI treatment and any other
potential non-TKI treatment to grade 1 or below

- Sufficient organ functions as defined in the protocol

- Absence of earlier or present certain other conditions as defined in the protocol

- No pregnancy or lactation

- Women with childbearing potential must accept the use of adequate contraception
throughout the study period

- Written informed consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate

Outcome Description:

The ratio of patients with CR (complete remission) + PR (partial remission) + SD (stable disease) at week 12 after start of treatment

Outcome Time Frame:

Week 12

Safety Issue:

No

Authority:

Sweden: Medical Products Agency

Study ID:

SSG XXI

NCT ID:

NCT01524848

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Clinical trial
  • Investigational drugs
  • Gastrointestinal stromal tumors
  • Pazopanib
  • Gastrointestinal Stromal Tumors

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