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Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600886
First received: January 14, 2008
Last updated: June 5, 2017
Last verified: June 2017
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Acromegaly
Interventions: Drug: Pasireotide
Drug: Octreotide

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Pasireotide LAR Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
Octreotide LAR Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.

Participant Flow for 3 periods

Period 1:   Core Phase - Full Analysis Set (FAS)
    Pasireotide LAR   Octreotide LAR
STARTED   176   182 
Did Not Enter Extension   29   29 
Entered Extension, Crossed Over   38   81 
Entered Ext Continued Same Treatment   74   46 
COMPLETED   141 [1]   156 [1] 
NOT COMPLETED   35   26 
Adverse Event                14                6 
Protocol Violation                7                8 
Lack of Efficacy                5                8 
Withdrawal by Subject                5                3 
Administrative Problems                2                0 
Abnormal laboratory value(s)                1                0 
Lost to Follow-up                1                0 
Death                0                1 
[1] Completed = anyone who did not discontinue prior to month 12.

Period 2:   Extension - Same Treatment (FAS)
    Pasireotide LAR   Octreotide LAR
STARTED   74 [1]   46 [2] 
Completed Study at Month 26   0 [3]   31 [4] 
Completed Study After Month 26   28 [5]   4 [6] 
Discontinued After Month 26   23   1 [7] 
Discontinued Between M12 and M26   23   10 
COMPLETED   28 [8]   35 [9] 
NOT COMPLETED   46   11 
Withdrawal by Subject                16                2 
Lack of Efficacy                3                3 
Administrative Problems                9                3 
Lost to Follow-up                3                1 
Adverse Event                4                1 
Abnormal Lab Value (s)                4                0 
Death                1                1 
Condition no longer requires study drug                6                0 
[1] Started = anyone who entered the extension and continued the same treatment of Pasireotide LAR
[2] Started = anyone who entered the extension and continued the same treatment of Octreotide LAR
[3] Pas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
[4] Per protocol, pts who received Octreotide LAR in ext. phase were not followed in the study after M26
[5] Completed = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
[6] Received treatment and completed after M26: Recorded as protocol deviation
[7] Received treatment and discontinued after M26: Recorded as protocol deviation
[8] Completed= completed after M26, switched to commercial pasireotide LAR or entered roll-over protocol
[9] Completed = completed the study

Period 3:   Extension - After Crossover (CAS)
    Pasireotide LAR   Octreotide LAR
STARTED   81 [1]   38 [2] 
Completed Study at Month 26   0 [3]   25 [4] 
Completed After Month 26   19 [5]   0 [4] 
Discontinued Between M12 and M26   31   13 
Discontinued After M26   31   0 [4] 
COMPLETED   19 [6]   25 [7] 
NOT COMPLETED   62   13 
Adverse Event                19                1 
Withdrawal by Subject                19                4 
Lack of Efficacy                13                4 
Administrative Problems                4                4 
Subject no longer requires study drug                3                0 
Abnormal Lab Value (s)                3                0 
Death                1                0 
[1] Started = anyone who entered the extension and crossed over to Pasireotide LAR
[2] Started = anyone who entered the extension and crossed over to Octreotide LAR
[3] Pas. LAR pts in Ext. were not considered completers at M26 as treatment could continue after M26.
[4] Per protocol, Pts who received Octreotide LAR in Ext. phase were not followed in study after M26
[5] Completed = Pts who transferred to a roll-over protocol or commercial supply of Pasireotide LAR
[6] Completed after month 26: transferred to a roll-over protocol or commercial supply of Pas.LAR
[7] Completed the study



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Full Analysis Set: All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.

Reporting Groups
  Description
Pasireotide LAR Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
Octreotide LAR Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Total Total of all reporting groups

Baseline Measures
   Pasireotide LAR   Octreotide LAR   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   182   358 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.1  (12.37)   45.6  (12.97)   45.4  (12.67) 
Age, Customized 
[Units: Participants]
     
<65 Years   168   167   335 
>=65 years   8   15   23 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      91  51.7%      95  52.2%      186  52.0% 
Male      85  48.3%      87  47.8%      172  48.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1   [ Time Frame: 12 months ]

2.  Secondary:   Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L   [ Time Frame: 12 Months ]

3.  Secondary:   Change From Baseline in Tumor Volume at 12 Months   [ Time Frame: Baseline, 12 Months ]

4.  Secondary:   Percentage of Participants With Normalization of IGF-1   [ Time Frame: 12 Months ]

5.  Secondary:   Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1   [ Time Frame: Months 3, 6, 9, 12, 16, 19, 22, 25 ]

6.  Secondary:   Summary of Mean GH Values   [ Time Frame: Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25 ]

7.  Secondary:   Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )   [ Time Frame: Up to 26 months ]

8.  Secondary:   Severity Scores of Acromegaly Symptoms   [ Time Frame: Baseline, Months 12, 25 ]

9.  Secondary:   Ring Size   [ Time Frame: Baseline, Months 12, 25 ]

10.  Secondary:   Health-related Quality-of-life as Measured by the AcroQoL Questionnaire   [ Time Frame: Baseline, Months 12, 25 ]

11.  Secondary:   Summary of Prolactin Levels   [ Time Frame: Baseline, Months 12, 25 ]

12.  Secondary:   Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)   [ Time Frame: Up to 26 months ]

13.  Secondary:   Pasireotide Trough Concentrations by Incident Dose   [ Time Frame: Months 1 - 12 ]

14.  Secondary:   Octreotide Trough Concentrations by Incident Dose   [ Time Frame: Months 1 - 12 ]

15.  Secondary:   Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover   [ Time Frame: Months 3, 6, 9, 12 after crossover ]

16.  Secondary:   Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L   [ Time Frame: Months 3, 6, 9, 12, 16, 19, 22, 25 ]

17.  Secondary:   Percentage of Participants With Normalization of IGF-1   [ Time Frame: Months 3, 6, 9, 12, 16, 19, 22, 25 ]

18.  Secondary:   Change From Baseline in Tumor Volume   [ Time Frame: Baseline, months 6, 12, 19, 25 ]

19.  Secondary:   Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover   [ Time Frame: Months 3, 6, 9, 12 after crossover ]

20.  Secondary:   Percentage of Participants With Normalization of IGF-1 After Crossover   [ Time Frame: Months 3, 6, 9, 12 after crossover ]

21.  Secondary:   Summary of Mean GH Values After Crossover   [ Time Frame: Extension baseline, months 3, 6, 9, 12 after crossover ]

22.  Secondary:   Change From Extension Baseline in Tumor Volume After Crossover   [ Time Frame: Extension baseline, months 6, 12 after crossover ]

23.  Secondary:   Severity Scores of Acromegaly Symptoms After Crossover   [ Time Frame: Extension baseline, month 12 after crossover ]

24.  Secondary:   Ring Size After Crossover   [ Time Frame: Extension baseline, month 12 after crossover ]

25.  Secondary:   Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover   [ Time Frame: Extension baseline, months 12 after crossover ]

26.  Secondary:   Summary of Prolactin Levels After Crossover   [ Time Frame: Extension baseline, month 12 after crossover ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600886     History of Changes
Other Study ID Numbers: CSOM230C2305
2007-001972-36 ( EudraCT Number )
Study First Received: January 14, 2008
Results First Received: December 19, 2014
Last Updated: June 5, 2017