ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00781911
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Carcinoma
Neuroendocrine Tumors
Interventions: Biological: Cixutumumab
Drug: depot octreotide

  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
Participants who completed the study include those who died and had progressive disease.

Reporting Groups
  Description
Carcinoid Tumor

Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Islet Cell Carcinoma

Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.


Participant Flow:   Overall Study
    Carcinoid Tumor   Islet Cell Carcinoma
STARTED   31   12 
Received at Least 1 Dose of Study Drug   31   12 
COMPLETED   25   4 
NOT COMPLETED   6   8 
Adverse Event                4                4 
Withdrawal by Subject                1                2 
Physician Decision                0                2 
Sponsor Decision                1                0 



  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.
No text entered.

Reporting Groups
  Description
Carcinoid Tumor

Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Islet Cell Carcinoma

Participants received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.

Total Total of all reporting groups

Baseline Measures
   Carcinoid Tumor   Islet Cell Carcinoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   12   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (9.65)   61.3  (9.85)   60.6  (9.60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  54.8%      4  33.3%      21  48.8% 
Male      14  45.2%      8  66.7%      22  51.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   6.5%      3  25.0%      5  11.6% 
Not Hispanic or Latino      29  93.5%      9  75.0%      38  88.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   3.2%      0   0.0%      1   2.3% 
White      30  96.8%      12 100.0%      42  97.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   31   12   43 


  Outcome Measures

1.  Primary:   Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months   [ Time Frame: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months) ]

2.  Secondary:   Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)   [ Time Frame: From Start of Treatment Baseline to Disease Progression (Up to 18 Months) ]

3.  Secondary:   Percentage of Participants With a Biochemical Response Rate   [ Time Frame: From Start of Treatment Up to 18 Months ]

4.  Secondary:   Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: 18 months ]

5.  Secondary:   Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1   [ Time Frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion ]

6.  Secondary:   PK: Half-life (t 1/2) Cycle 1   [ Time Frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion ]

7.  Secondary:   PK: Area Under Concentration (AUCinf) Cycle 1   [ Time Frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion ]

8.  Secondary:   PK: Clearance (CL) Cycle 1   [ Time Frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion ]

9.  Secondary:   PK: Volume at Steady State (Vss) Cycle 1   [ Time Frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion ]

10.  Secondary:   Serum Anti-Cixutumumab Antibody Assessment   [ Time Frame: 18 months ]

11.  Secondary:   Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00781911     History of Changes
Other Study ID Numbers: 13929
CP13-0710 ( Other Identifier: ImClone Systems )
I5A-IE-JAEE ( Other Identifier: Eli Lilly and Company )
First Submitted: October 27, 2008
First Posted: October 29, 2008
Results First Submitted: March 17, 2018
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018