Expired Study
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Boston, Massachusetts 02114


Purpose:

Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with Cushing's disease.


Criteria:

Inclusion Criteria: - Patients who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Patients who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the patient is getting significant clinical benefits from treatment with Pasireotide . - The patient did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment. - Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended Exclusion Criteria: - Patients who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or HgbA1C > 10 since starting [study CSOM230B2208] - Patients with persistent ALT/AST or alkaline phosphatase levels more than 2.5X ULN, serum creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN - Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits), WBC <3.0x1'000'000'000/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT <100x1'000'000'000/L Other protocol-defined inclusion / exclusion criteria may apply.


Study is Available At:


Original ID:

CSOM230B2208E1


NCT ID:

NCT00171951


Secondary ID:

2004-002407-32


Study Acronym:


Brief Title:

Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease


Official Title:

Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

19


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticlas
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:August 2004
Completion Date:July 2013
Completion Type:Actual
Primary Completion Date:July 2013
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 15, 2016
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Long term efficacy (UFC) in patients with Cushing's disease
Time Frame:at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Long term safety
Time Frame:at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Tolerability
Time Frame:at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics
Time Frame:at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Development of biomarker
Time Frame:at the end of the study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pasireotide
Arm Name:Pasireotide

Study Arms

Study Arm Type:Experimental
Arm Name:Pasireotide

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Boscaro M, Bertherat J, Findling J, Fleseriu M, Atkinson AB, Petersenn S, Schopohl J, Snyder P, Hughes G, Trovato A, Hu K, Maldonado M, Biller BM. Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study. Pituitary. 2014 Aug;17(4):320-6. doi: 10.1007/s11102-013-0503-3.
PMID:23943009

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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