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Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly (PAOLA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01137682
First received: May 27, 2010
Last updated: November 4, 2014
Last verified: November 2014

May 27, 2010
November 4, 2014
July 2010
January 2013   (final data collection date for primary outcome measure)
Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01137682 on ClinicalTrials.gov Archive Site
  • Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measure the tumor volume reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the IGF-1 level alone at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the overall safety and tolerability of Pasireotide LAR 40 mg and pasireotide LAR 60 mg [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Measure the health-related quality of life using the AcroQoL instrument [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Measure the mean GH levels and IGF-1 levels at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measure the tumor size reduction assessed by pituitary MRI at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
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

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acromegaly
  • Drug: Pasireotide (SOM230)
    • Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
    • Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
  • Drug: octreotide LAR 30mg
    In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
  • Drug: lanreotide ATG 120mg
    In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization
  • Experimental: Pasireotide LAR 40 mg
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
    Intervention: Drug: Pasireotide (SOM230)
  • Experimental: Pasireotide LAR 60 mg
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
    Intervention: Drug: Pasireotide (SOM230)
  • Active Comparator: Control arm (octreotide or lanreotide)

    If a patient is randomized to the open label arm the investigator will either:

    • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or
    • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
    Interventions:
    • Drug: octreotide LAR 30mg
    • Drug: lanreotide ATG 120mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
December 2015
January 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   Colombia,   France,   Germany,   Israel,   Italy,   Norway,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   Spain,   Turkey,   United Kingdom
 
NCT01137682
CSOM230C2402, 2009-016722-13, EUDRACT 2009-016722-13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2014

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