Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01524848
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2012-01-24
Brief Title:
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
Sponsor:
Scandinavian Sarcoma Group
Organization:
Scandinavian Sarcoma Group
Study Overview
Official Title:
Pazopanib in Advanced GISTs Refractory to Imatinib and Sunitinib - A Non-comparative Phase II Multicenter Study by the Scandinavian Sarcoma Group
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAGIST
Brief Summary:
Patients with metastatic or locally advanced gastrointestinal stromal tumors GIST who develop resistance against the two hitherto approved drugs for this disease the tyrosin kinase inhibitors TKIs imatinib and sunitinib have a poor prognosis Sometimes a further response may be achieved by other drugs mainly other TKIs which have been explored in different studies but not yet have been approved for clinical use Pazopanib is a TKI inhibiting the tyrosin kinases KIT PDGFRA and VEGF 1-3 all of which have important roles in the pathogenesis of GIST Theoretically it may function in GIST and it deserves investigational trials The drug is approved for metastatic renal cancer and is relatively well tolerated In this trial SSG XXI the disease control rate DCR CRPRSD after 12 weeks of treatment will be assessed as the primary endpoint and at the same time trough levels will be measured Secondary endpoints include ORR PFS toxicity and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor if known The goal is to include 72 patients in the trial which is open and single arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None