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Trial Outcomes & Findings for Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients (NCT NCT00585221)

NCT ID: NCT00585221

Last Updated: 2017-02-10

Results Overview

Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

18 months

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure
All Patients
All participants enrolled.
Overall Study
STARTED
8
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
8

Reasons for withdrawal

Reasons for withdrawal
Measure
All Patients
All participants enrolled.
Overall Study
Protocol Violation
8

Baseline Characteristics

Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=8 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
Age, Continuous
64.875 years
STANDARD_DEVIATION 17.97 • n=5 Participants
Gender
Female
3 Participants
n=5 Participants
Gender
Male
5 Participants
n=5 Participants
Region of Enrollment
United States
8 participants
n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: two years

Outcome measures

Outcome data not reported

Adverse Events

All Enrolled

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Huntsman Cancer Institute

Phone: 801-213-4241

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place