Efficacy of Rosiglitazone Maleate on Cushing Disease
| Group | Value |
|---|---|
| Group 1 (ACTH-secreting Adenomas) | not posted |
| Group 2 (Non-secreting Macroadenomas) | not posted |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: low patient recruitment
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and grow and spread more slowly. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed or residual or recurrent pituitary adenoma.
Experimental
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.
Experimental
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.
Outcomes the sponsor listed as primary.
Efficacy of Rosiglitazone Maleate on Cushing Disease
Time frame · 12 months
Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Group 1 (ACTH-secreting Adenomas) | not posted |
| Group 2 (Non-secreting Macroadenomas) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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 | – | 0 / 0 | 0 / 0 |
| 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 | – | 0 / 1 | 0 / 1 |
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