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A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

Phase 3
18 Years
Open (Enrolling)
Cushing's Disease

Thank you

Trial Information

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

Inclusion Criteria:

- Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able
to care for most of their personal needs)

- For patients on medical treatment for Cushing's disease the following washout periods
must be completed before screening assessments are performed

- Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week

- Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and
PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks

- Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks

- Octreotide (immediate release formulation): 1 week

Exclusion Criteria:

- Patients who are considered candidates for surgical treatment at the time of study

- Patients who have received pituitary irradiation within the last ten years prior to
visit 1

- Patients who have had any previous pasireotide treatment

- Patients who have been treated with mitotane during the last 6 months prior to Visit

- Diabetic patients on antihyperglycemic medications with poor glycemic control as
evidenced by HbA1c >8%

- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT
syndrome, or concomitant medications known to prolong QT interval

- Female patients who are pregnant or lactating, or are of childbearing potential
(defined as all women physiologically capable of becoming pregnant) and not
practicing an effective method of contraception/birth control. Sexually active males
must use a condom during intercourse while taking the drug and for 2 months after the
last dose of study drug and should not father a child in this period. A condom is
required to be used also by vasectomized men in order to prevent delivery of the drug
via seminal fluid

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently

Outcome Description:

To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains Mean Urinary Free Cortisol (mUFC) ≤ 1.0 X Upper Limit of Normal (ULN) at month 7 regardless of dose-titration.

Outcome Time Frame:

7 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

August 2016

Related Keywords:

  • Cushing's Disease
  • Cushing's Disease
  • Mean Urinary Free Cortisol
  • Pasireotide
  • Cushing Syndrome
  • Pituitary ACTH Hypersecretion



Stanford University Medical Center SC Stanford, California  94304
Cleveland Clinic Foundation CCF - Euclid Loc Cleveland, Ohio  44195
University of Pennsylvania - Clinical Studies Unit Unniv SC Philadelphia, Pennsylvania  19104
University of Texas Southwestern Medical Center UT southwest Dallas, Texas  75390-8527
Swedish Medical Center Swedish Seattle, Washington  
Medical College of Wisconsin MCW 2 Milwaukee, Wisconsin  53226
ClinTriCo Phoenix, Arizona  85083
University of California at Los Angeles UCLA Tiverton Los Angeles, California  90095
John Wayne Cancer Center Santa Monica, California  90404
Harbor-UCLA Medical Center LA Biomed Torrance, California  90509
Emory University School of Medicine/Winship Cancer Institute G2304 Atlanta, Georgia  30322
Pituitary Center, Division of Endocrinology SC Baltimore, Maryland  21287
University of Michigan Comprehensive Cancer Center SC-2 Ann Arbor, Michigan  48109-0944
Mount Sinai School of Medicine Mt. Sinai Medical Center New York, New York  10029
Oregon Health & Sciences University DeptofOregonHealth&Sciences(2) Portland, Oregon  97201