Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01459757

Collaborator

(none)

322

Enrollment

Locations

Duration (Months)

8.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

Condition or Disease	Intervention/Treatment	Phase
GIST	Other: non-interventional

Detailed Description

This is a non-interventional trial. No active patients will participate in this study. Only data generated from the A6181036 study will be utilized for correlational purposes. The A6181036 study data in addition to mutational status data previously analyzed but not collected as part of the A6181036 study in the same patient population

Study Design

Study Type:

Observational

Actual Enrollment :

322 participants

Time Perspective:

Retrospective

Official Title:

A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Data generated from the past sunitinib A6181036 GIST study	Other: non-interventional Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.

Arm

Intervention/Treatment

Data generated from the past sunitinib A6181036 GIST study

Other: non-interventional

Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.

Outcome Measures

Primary Outcome Measures

Mutational status data retrospectively accessed correlated with A6181036 clinical outcomes data in GIST subjects treated with sunitinib [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

GIST subjects that participated in the A6181036 study that had mutational status data analyzed.

Exclusion Criteria:

Subjects not participating in the A6181036 study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Davis Cancer Pavilion and Shands Medical Plaza	Gainesville	Florida	United States	32608
4	Shands Cancer Hospital at the University of Florida	Gainesville	Florida	United States	32608
5	Shands Hospital at the University of Florida	Gainesville	Florida	United States	32608
6	Moffitt Cancer Center	Tampa	Florida	United States	33612
7	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
8	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
9	Masonic Cancer Center - Clinical Trials Office	Minneapolis	Minnesota	United States	55455
10	Oregon Health and Science University	Portland	Oregon	United States	97239
11	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
12	University of Washington	Seattle	Washington	United States	98195
13	Prince of Wales Hospital, Oncology Day Center	Randwick	New South Wales	Australia	2031
14	Ashford Cancer Centre Research	Kurralta Park	South Australia	Australia	5037
15	Peter MacCallum Cancer Institute, Department of Medical Oncology	East Melbourne	Victoria	Australia	3002
16	UZ Leuven	Leuven		Belgium	3000
17	Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal	Montreal	Quebec	Canada	H2L 4M1
18	Herlev Hospital	Herlev		Denmark	2730
19	Helsingin yliopistollinen keskussairaala/Syopatautien klinikka	Helsinki		Finland	00290
20	Institut Bergonie	Bordeaux Cedex		France	33076
21	Centre L� B�rd	Lyon Cedex		France	69373
22	CHU La Timone, Service d'Oncologie Medicale	Marseille		France	13385
23	HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie	Berlin		Germany	13125
24	Schwerpunktpraxis fuer ambulante Tumortherapie	Duesseldorf		Germany	40212
25	Klinikum der Universitaet zu Koeln	Koeln		Germany	50937
26	Tata Memorial Centre	Mumbai	Maharashtra	India	400012
27	Seoul National University Hospital/Department of Internal Medicine	Seoul		Korea, Republic of	110-744
28	Asan Medical Center, Department of Internal Medicine	Seoul		Korea, Republic of	138-736
29	Leids Universitair Medisch Centrum/ Klinische Oncologie	Leiden		Netherlands	2333 ZA
30	Klinika Nowotworow Tkanek Miekkich i Kosci	Warszawa		Poland	02-781
31	Narodny Onkologicky ustav	Bratislava		Slovakia	833 10
32	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
33	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
34	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011
35	Sarcoma Unit	London		United Kingdom	SW3 6JJ
36	Christie Hospital NHS Trust	Manchester		United Kingdom	M20 4BX