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: July 20, 2015
Last verified: July 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acromegaly
Interventions: Drug: Pasireotide (SOM230)
Drug: octreotide LAR 30mg
Drug: lanreotide ATG 120mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 Patients were not treated. 2 patients did not receive any study medication but had incorrect data entered in dosing CRF and therefore listed as treated below.

Reporting Groups
  Description
Pasireotide LAR 40 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Pasireotide LAR 60 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
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.

Participant Flow:   Overall Study
    Pasireotide LAR 40 mg     Pasireotide LAR 60 mg     Control Arm (Octreotide or Lanreotide)  
STARTED     65     65     68  
Not Treated     2     1     1  
Treated     63     64     67  
Completed 24-Week Core Phase     59     57     65  
Not Continuing Into Extension     3     4     3  
Continuing Into Extension     56     53     62  
Safety Set     63 [1]   62 [2]   66 [1]
COMPLETED     59     57     65  
NOT COMPLETED     6     8     3  
Adverse Event                 2                 4                 0  
Withdrawal by Subject                 2                 2                 2  
Administrative Problems                 2                 1                 0  
Protocol Violation                 0                 1                 1  
[1] 2 patients never received drug.
[2] 2 patients never received drug. 1 patient had no post baseline safety assement.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pasireotide LAR 40 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
Pasireotide LAR 60 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
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.
Total Total of all reporting groups

Baseline Measures
    Pasireotide LAR 40 mg     Pasireotide LAR 60 mg     Control Arm (Octreotide or Lanreotide)     Total  
Number of Participants  
[units: participants]
  65     65     68     198  
Age, Customized  
[units: Participants]
       
<65 Years     62     57     63     182  
≥ 65 Years     3     8     5     16  
Gender  
[units: Participants]
       
Female     38     35     38     111  
Male     27     30     30     87  
Race/Ethnicity, Customized  
[units: Participants]
       
Caucasian     53     52     56     161  
Black     3     8     4     15  
Other     4     3     7     14  
Native American     2     1     1     4  
Asian     3     1     0     4  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.   [ Time Frame: 24 weeks ]

2.  Secondary:   Perecentage of Participants Achieving Normalization of Sex- and Age-adjusted IGF-1   [ Time Frame: 24 weeks ]

3.  Secondary:   Percentage of Participants Achieving Biochemical Control Defined as Mean GH Levels < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.   [ Time Frame: 12 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

4.  Secondary:   Percentage of Participants Achieving GH Levels < 2.5 µg/L.   [ Time Frame: Weeks 12 and 24 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

5.  Secondary:   Percentage of of Participants Achieving GH Levels < 1 µg/L and Normal, Sex- and Age-adjusted IGF-1.   [ Time Frame: Weeks 12 and 24 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

6.  Secondary:   Percentage of Participants Achieving GH Levels < 1 µg/L.   [ Time Frame: Weeks 12 and 24 ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

7.  Secondary:   Percentage of Participants Achieving a Tumor Volume Reduction > 25% Assessed by Pituitary MRI.   [ Time Frame: 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

8.  Secondary:   Percent Change in Tumor Volume Assessed by Pituitary MRI.   [ Time Frame: Baseline, 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

9.  Secondary:   Change From Baseline in Clinical Signs/Symptoms of Acromegaly (Ring Size; Headache, Fatigue, Perspiration, Paresthesias and Osteoarthralgia According to a Five-point Score Scale)   [ Time Frame: Baseline, 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

10.  Secondary:   Change From Baseline in Health Related QoL as Measured by the AcroQoL (Acromegaly Health Related QoL)   [ Time Frame: Baseline, 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No

11.  Secondary:   PK Levels of Pasireotide LAR 40 mg and Pasireotide LAR 60 mg   [ Time Frame: 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01137682     History of Changes
Other Study ID Numbers: CSOM230C2402, 2009-016722-13, EUDRACT 2009-016722-13
Study First Received: May 27, 2010
Results First Received: January 13, 2015
Last Updated: July 20, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Colombia: Institutional Review Board
France: Ministry of Health
Germany: Ministry of Health
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Spain: Ministry of Health and Consumption
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Mexico: Ministry of Health