A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01316263
First received: March 14, 2011
Last updated: November 18, 2016
Last verified: November 2016
Results First Received: November 18, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor (GIST)
Intervention: Biological: Olaratumab

  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
Participants who were considered to have completed Stage 1 of the study discontinued due to progressive disease (PD) or died.

Reporting Groups
  Description
PDGFRα Mutation Positive 20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
PDGFRα Mutation Negative (Wild-Type) 20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.

Participant Flow:   Overall Study
    PDGFRα Mutation Positive   PDGFRα Mutation Negative (Wild-Type)
STARTED   7   14 
Received Any Study Drug   7   14 
COMPLETED   7   14 
NOT COMPLETED   0   0 



  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.
All participants who received any study drug.

Reporting Groups
  Description
PDGFRα Mutation Positive 20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
PDGFRα Mutation Negative (Wild-Type) 20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
Total Total of all reporting groups

Baseline Measures
   PDGFRα Mutation Positive   PDGFRα Mutation Negative (Wild-Type)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   14   21 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (7.90)   48.9  (9.11)   54.2  (11.48) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  28.6%      7  50.0%      9  42.9% 
Male      5  71.4%      7  50.0%      12  57.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      7 100.0%      14 100.0%      21 100.0% 
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      0   0.0%      0   0.0%      0   0.0% 
White      7 100.0%      14 100.0%      21 100.0% 
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]
     
United States   2   3   5 
Spain   0   1   1 
Poland   2   4   6 
Belgium   1   2   3 
Netherlands   0   2   2 
Germany   2   2   4 
Eastern Cooperative Oncology Group Performance Status(ECOG PS) [1] 
[Units: Participants]
     
ECOG PS =0   2   5   7 
ECOG PS =1   4   9   13 
ECOG PS ≥2   1   0   1 
[1]

ECOG classifies participants according to their functional impairment. Scores range from 0 (fully active) to 5 (death).

0=Fully active, able to carry on all pre-disease performance without restriction; 1=Ambulatory, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory, no work activities; 3=Partially confined to bed, limited self-care; 4=Completely disabled.

Type of Cancer-Gastrointestinal Stromal Tumor 
[Units: Participants]
 7   14   21 
Histology-Cell Type 
[Units: Participants]
     
Epitheloid Cell   6   0   6 
Spindle Cell   0   9   9 
Mixed/Combined   0   4   4 
Other-unspecified   1   1   2 
Initial T Classification Staging at Diagnosis [1] 
[Units: Participants]
     
Tis   0   1   1 
T2   1   3   4 
T3   0   4   4 
T4   3   1   4 
TX   1   4   5 
Missing   2   1   3 
[1] Staging: T0=no evidence of primary tumor; Tis=Carcinoma in situ; T1 to 4=presence of tumors, higher numbers indicate increased size, extent or degree of penetration; TX=primary tumor could not be assessed.
Initial N Classification Staging at Diagnosis [1] 
[Units: Participants]
     
N0   5   11   16 
N1   0   1   1 
Missing   2   2   4 
[1] Staging: N0=no regional lymph nodes metastasis; N1 to N3=Regional lymph node metastasis, higher number indicated greater involvement.
Initial M Stage at Diagnosis [1] 
[Units: Participants]
     
M0   4   7   11 
M1   1   5   6 
MX   0   1   1 
Missing   2   1   3 
[1] Staging: presence or absence of distance metastasis, including lymph nodes that were not regional. M0=no distant metastasis; M1=distant metastasis; MX=distance metastasis could not be assessed.
Current T Classification Staging [1] 
[Units: Participants]
     
T0   2   2   4 
T3   0   4   4 
T4   2   2   4 
TX   2   4   6 
Unknown   0   1   1 
Missing   1   1   2 
[1] Staging: T0=no evidence of primary tumor; Tis=Carcinoma in situ; T1 to 4=presence of tumors, higher numbers indicate increased size, extent or degree of penetration; TX=primary tumor could not be assessed.
Current N Classification Staging [1] 
[Units: Participants]
     
N0   5   8   13 
N1   0   3   3 
N2   1   0   1 
Missing   1   3   4 
[1] Staging: N0=no regional lymph nodes metastasis; N1 to N3=Regional lymph node metastasis, higher number indicated greater involvement.
Current M Classification Staging [1] 
[Units: Participants]
     
M1   6   13   19 
Missing   1   1   2 
[1] Staging: presence or absence of distance metastasis, including lymph nodes that were not regional. M0=no distant metastasis; M1=distant metastasis; MX=distance metastasis could not be assessed.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks ]

3.  Secondary:   Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]   [ Time Frame: Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Date of first dose of study drug to the date of death from any cause up to 57.3 weeks ]

5.  Secondary:   Number of Participants With Adverse Events (AE) and Participants Who Died   [ Time Frame: Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up ]

6.  Secondary:   Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]   [ Time Frame: Baseline up to 35.9 weeks ]

7.  Secondary:   Maximum Concentration (Cmax)   [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]

8.  Secondary:   Area Under the Curve (AUC)   [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]

9.  Secondary:   Half Life (t½)   [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]

10.  Secondary:   Clearance (CL)   [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]

11.  Secondary:   Volume of Distribution at Steady State (Vss)   [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]

12.  Secondary:   Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results   [ Time Frame: Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles) ]


  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
The development of olaratumab (IMC-3G3) was put on hold in this indication due to reasons not related to efficacy and/or safety, Stage 2 of this study was not completed.


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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01316263     History of Changes
Other Study ID Numbers: 14244
CP15-1008 ( Other Identifier: ImClone, LLC )
I5B-IE-JGDH ( Other Identifier: Eli Lilly and Company )
2010-022560-12 ( EudraCT Number )
Study First Received: March 14, 2011
Results First Received: November 18, 2016
Last Updated: November 18, 2016