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Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01374906
First received: June 14, 2011
Last updated: May 25, 2017
Last verified: May 2017
June 14, 2011
May 25, 2017
November 4, 2011
November 22, 2016   (Final data collection date for primary outcome measure)
Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]
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.
Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]
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 mUFC ≤ 1.0 X ULN at month 7 regardless of dose-titration.
Complete list of historical versions of study NCT01374906 on ClinicalTrials.gov Archive Site
  • Proportion of responders in each of the Pasireotide LAR (long acting release) 10 mg and 30 mg doses independently in patients with Cushing's disease after 7 months of treatment who did not up titrate the doses of Pasireotide at month 4. [ Time Frame: 7 months ]
    A responder is defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.
  • Change in mean urinary free cortisol from baseline at every month in the core and every 3 months in extension within the two Pasireotide LAR regimens [ Time Frame: 26 months ]
  • Proportion of responders in the two Pasireotide LAR regimens at every month in the core and every 3 months in the extension phases [ Time Frame: 26 months ]
  • Proportion of responders in the two Pasireotide LAR regimens as measured by controlled and partially controlled mUFC(mean urinary free cortisol) combined responders at every month in the core and every 3 months in the extension [ Time Frame: 26 months ]
  • Controlled mUFC (mean urinary free cortisol)response of the two Pasireotide regimens by month 7 and 12 [ Time Frame: 12 months ]
    To evaluate the frequency of controlled mUFC response of the two Pasireotide regimens by month 7 and 12.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease
This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Cushing's Disease
  • Drug: SOM230 LAR 30 mg
    starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.
  • Drug: SOM230 LAR 10 mg
    starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.
  • Experimental: 10 mg LAR dose
    Intervention: Drug: SOM230 LAR 10 mg
  • Experimental: 30 mg LAR dose
    Intervention: Drug: SOM230 LAR 30 mg
Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
November 22, 2016
November 22, 2016   (Final data collection date for primary outcome measure)

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 entry
  • 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 1
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   India,   Israel,   Italy,   Japan,   Netherlands,   Peru,   Poland,   Russian Federation,   Spain,   Thailand,   Turkey,   United Kingdom,   United States
 
 
NCT01374906
CSOM230G2304
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Undecided

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP