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A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Acromegaly

Thank you

Trial Information

A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly


Inclusion Criteria:



1. Patients with written informed consent prior to any study related activity

2. Patients with inadequately controlled acromegaly as defined by a mean GH
concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and
age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)

3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for
at least 6 months prior to visit 1 (screening). The maximum indicated dose for
octreotide LAR is 30mg and for lanreotide ATG is 120 mg

4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been
previously submitted to surgery

Exclusion Criteria:

1. Patients who have received pasireotide (SOM 230) prior to enrolment

2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine
agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1
(screening)(8 weeks wash out period). Such patients must have been treated with
octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum
of 6 months prior to starting combination therapy and they should have been
inadequately controlled on monotherapy.

3. Patients with compression of the optic chiasm causing acute clinically significant
visual field defects

4. Patients who require a surgical intervention for relief of any sign or symptom
associated with tumor compression

5. Patients who have received pituitary irradiation within 10 years prior to visit 1
(screening).

6. Patients who have undergone major surgery/surgical therapy for any cause within 4
weeks prior to visit 1 (screening).

7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid
hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230C2402

NCT ID:

NCT01137682

Start Date:

July 2010

Completion Date:

December 2015

Related Keywords:

  • Acromegaly
  • Acromegaly
  • hormone disorder
  • growth hormone
  • insulin like growth factor-1
  • pituitary tumor
  • Acromegaly

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cedars Sinai Medical CenterLos Angeles, California  90048-1804
University of MichiganAnn Arbor, Michigan  48109-0624
Johns Hopkins School of MedicineBaltimore, Maryland  21205
Stanford University Medical CenterStanford, California  94305-5408
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
Oregon Health & Science UniversityPortland, Oregon  97201
Oregon Health and Sciences UniversityPortland, Oregon  
University of Texas Southwestern Medical CenterDallas, Texas  
University of California at Los AngelesLos Angeles, California  90095
Swedish Neuroscience InstituteSeattle, Washington  98122
Cedars Sinai Medical Center Dept. of Pituitary Ctr.Los Angeles, California  90048
Allegheny Endocrinology AssociatesPittsburgh, Pennsylvania  15212
The Regents of the University of CaliforniaIrvine, California  92697
University of Michigan Ann ArborAnn Arbor, Michigan  48109
University of Texas Southwest Medical CenterDallas, Texas  75390
Swedish Medical Center Neuroscience InstituteSeattle, Washington  98122