Trial Outcomes & Findings for Rosiglitazone in Treating Patients With Pituitary Tumors (NCT NCT00616642)
NCT ID: NCT00616642
Last Updated: 2020-08-14
Results Overview
Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
12 months
Results posted on
2020-08-14
Participant Flow
2006 - May 2009
Participant milestones
| Measure |
Group 1 (ACTH-secreting Adenomas)
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
Group 2 (Non-secreting Macroadenomas)
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (ACTH-secreting Adenomas)
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
Group 2 (Non-secreting Macroadenomas)
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Rosiglitazone in Treating Patients With Pituitary Tumors
Baseline characteristics by cohort
| Measure |
Group 1 (ACTH-secreting Adenomas)
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
Group 2 (Non-secreting Macroadenomas)
n=1 Participants
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
rosiglitazone maleate : Given orally
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: No data was analyzed for this outcome measure as there was insufficient data to perform analysis.
Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.
Outcome measures
Outcome data not reported
Adverse Events
Group 1 (ACTH-secreting Adenomas)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (Non-secreting Macroadenomas)
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
Anthony Heaney, M.D. Ph.D
University of California Los Angeles
Phone: 310 267 4980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place