AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00427349
First received: January 25, 2007
Last updated: May 19, 2015
Last verified: May 2015
Results First Received: May 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome
Interventions: Drug: AMG 706
Drug: octreotide

  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
This study was activated on September 16, 2008 and closed on March 18, 2010 with 46 patients registered to the study from 10 ECOG-ACRIN affiliated institutions.

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
AMG 706+Octreotide

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.


Participant Flow:   Overall Study
    AMG 706+Octreotide  
STARTED     46  
Eligible     45  
Treated     45  
Eligible and Treated     44  
COMPLETED     0 [1]
NOT COMPLETED     46  
Lack of Efficacy                 23  
Adverse Event                 14  
Death                 1  
Withdrawal by Subject                 3  
Alternative therapy                 1  
Unknown                 2  
Ineligible                 1  
Never started therapy                 1  
[1] Treatment continued until disease progression or intolerable toxicity



  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.
Per protocol, the primary population for all efficacy analysis is all eligible and treated patients

Reporting Groups
  Description
AMG 706+Octreotide

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.


Baseline Measures
    AMG 706+Octreotide  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Median (Full Range)
  65   (38 to 81)  
Gender  
[units: participants]
 
Female     20  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures
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1.  Primary:   Four-month Progression-free Survival Rate   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry ]

2.  Secondary:   Overall Survival   [ Time Frame: assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry ]

3.  Secondary:   Objective Response Rate   [ Time Frame: assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00427349     History of Changes
Other Study ID Numbers: CDR0000526256, ECOG-E4206, U10CA023318
Study First Received: January 25, 2007
Results First Received: May 19, 2015
Last Updated: May 19, 2015
Health Authority: United States: Food and Drug Administration