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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00612066
Date of registration: 08/02/2008
Prospective Registration: No
Primary sponsor: Jonsson Comprehensive Cancer Center
Public title: Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)
Scientific title: An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease
Date of first enrolment: April 2007
Target sample size: 2
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Name:     Anthony Heaney, MD
Affiliation:  Jonsson Comprehensive Cancer Center
Key inclusion & exclusion criteria


- Clinically demonstrable ACTH-secreting pituitary tumor

- Pituitary tumor demonstrated on MRI with and without contrast AND/OR evidence of
a central ACTH source following inferior petrosal sinus sampling

- Newly diagnosed disease

- Biochemically active disease that is not adequately controlled, as demonstrated by the
following standard criteria:

- Elevated 24-hour urinary-free cortisol levels on at least 2 separate 24-hour
urine collections 1 week apart

- Lack of suppression of serum cortisol to < 1.8 µg/dL (at 8 am) following
administration of 1 mg of dexamethasone at 11 pm the night before

- Measurable plasma ACTH levels

- Patient is hypercortisolemic and does not wish to receive alternate steroid-lowering
therapy, such as ketoconazole and/or metyrapone

- Patients with evidence of optic nerve or chiasm compression on post-operative MRI must
have a normal visual field evaluation by Goldman perimetry

- No visual field abnormalities

- Hypopituitarism* allowed, as evidenced by any or all of the following:

- Subnormal growth hormone (GH) response to arginine/growth hormone-releasing
hormone (GHRH) testing (normal response is an increase of > 4 ng/mL)

- Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels

- Low thyroid-stimulating hormone (TSH) levels

- Low free triiodothyronine (T3) and free thyroxine (T4) levels

- Low estradiol levels

- Low luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in
postmenopausal female patients

- Low testosterone, LH, and FSH levels in male patients NOTE: *Patients who are
diagnosed with hypopituitarism will initiate thyroid hormone replacement therapy
prior to pituitary surgery as part of routine care. Other hormone replacement,
such as sex steroids or growth hormone, will not be initiated during the study.


- Not pregnant or nursing

- Fertile patients must use effective contraception (if oral contraception is used, it
must be used for = 2 months prior to, during, and for 1 month after completion of
study therapy)

- No clinically significant renal, hematologic, or hepatic abnormalities

- No prior or concurrent medical condition that may interfere with the conduct of the
study or the evaluation of its results, in the opinion of the investigator or the DSMB
compliance officer

- No history of immunocompromise, including HIV positivity by ELISA and western blot

- No alcohol or drug abuse within the past 6 months

- No blood donation (= 400 mL) within the past 2 months

- No other active malignant disease within the past 5 years except for basal cell
carcinoma or carcinoma in situ of the cervix

- No active or suspected acute or chronic uncontrolled infection

- No severe osteoporosis, defined as bone mineral density T scores < 2.5 standard
deviations below age-matched controls

- No history of noncompliance to medical regimens

- Considered reliable

- Able to complete the entire study


- More than 3 months since prior rosiglitazone or other thiazolidinedione

- No prior or concurrent radiotherapy for pituitary tumor

- More than 1 month since prior participation in any clinical investigation involving an
investigational drug

- More than 30 days since prior unlicensed drugs

- No concurrent pituitary surgery

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Cushing's Disease
Drug: rosiglitazone maleate
Primary Outcome(s)
Number of Responders [Time Frame: 7 weeks]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institutes of Health (NIH)
Ethics review
Results available: Yes
Date Posted: 17/02/2016
Date Completed:
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