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

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ClinicalTrials.gov Identifier: NCT01316263
Recruitment Status : Terminated (Trial terminated strategically due to poor accrual.)
First Posted : March 16, 2011
Results First Posted : January 16, 2017
Last Update Posted : March 9, 2017
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
Condition Gastrointestinal Stromal Tumor (GIST)
Intervention Biological: Olaratumab
Enrollment 21
Recruitment Details  
Pre-assignment Details Participants who were considered to have completed Stage 1 of the study discontinued due to progressive disease (PD) or died.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 7 14
Received Any Study Drug 7 14
Completed 7 14
Not Completed 0 0
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 14 21
Hide Baseline Analysis Population Description
All participants who received any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 14 participants 21 participants
64.9  (7.90) 48.9  (9.11) 54.2  (11.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
Female
2
  28.6%
7
  50.0%
9
  42.9%
Male
5
  71.4%
7
  50.0%
12
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
ECOG PS =0 2 5 7
ECOG PS =1 4 9 13
ECOG PS ≥2 1 0 1
[1]
Measure Description:

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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
7 14 21
Histology-Cell Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
N0 5 11 16
N1 0 1 1
Missing 2 2 4
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
M0 4 7 11
M1 1 5 6
MX 0 1 1
Missing 2 1 3
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 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]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
N0 5 8 13
N1 0 3 3
N2 1 0 1
Missing 1 3 4
[1]
Measure Description: Staging: N0=no regional lymph nodes metastasis; N1 to N3=Regional lymph node metastasis, higher number indicated greater involvement.
Current M Classification Staging   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
M1 6 13 19
Missing 1 1 2
[1]
Measure Description: 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.
1.Primary Outcome
Title Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks
Hide Description Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(12.9 to 77.5)
14.3
(2.6 to 38.5)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.
Time Frame Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Median (90% Confidence Interval)
Unit of Measure: weeks
32.1
(5.0 to 35.9)
6.1
(5.7 to 6.3)
3.Secondary Outcome
Title Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]
Hide Description The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.
Time Frame Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
No participant achieved CR or PR.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.
Time Frame Date of first dose of study drug to the date of death from any cause up to 57.3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Median (90% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(10.9 to NA)
24.9
(14.4 to 49.1)
[1]
Median and 90% Confidence Interval upper limit were not evaluable due to high number of censored participants.
5.Secondary Outcome
Title Number of Participants With Adverse Events (AE) and Participants Who Died
Hide Description Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.
Time Frame Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Measure Type: Number
Unit of Measure: participants
SAEs 2 3
AEs 7 13
Died Due to AE 0 1
Died Due to Disease Progression 0 1
6.Secondary Outcome
Title Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]
Hide Description DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.
Time Frame Baseline up to 35.9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study drug.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
71.4
(34.1 to 94.7)
28.6
(10.4 to 54.0)
7.Secondary Outcome
Title Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Day 1 of Cycles 1 and 3 (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had evaluable pharmacokinetic (PK) Cmax results at the specific time point. Due to the limited data, Cmax is not representative of the study population.
Arm/Group Title Olaratumab (IMC-3G3)
Hide Arm/Group Description:
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 or PDGFRα wild type.
Overall Number of Participants Analyzed 3
Mean (Full Range)
Unit of Measure: nanograms per milliliter (ng/mL)
Day 1 Cycle 1 (n=2)
392.9
(314.0 to 471.8)
Day 1 Cycle 3 (n=1)
483.9 [1] 
(NA to NA)
[1]
Individual values are reported when n <2.
8.Secondary Outcome
Title Area Under the Curve (AUC)
Hide Description [Not Specified]
Time Frame Day 1 of Cycles 1 and 3 (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Half Life (t½)
Hide Description [Not Specified]
Time Frame Day 1 of Cycles 1 and 3 (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Clearance (CL)
Hide Description [Not Specified]
Time Frame Day 1 of Cycles 1 and 3 (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Volume of Distribution at Steady State (Vss)
Hide Description [Not Specified]
Time Frame Day 1 of Cycles 1 and 3 (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results
Hide Description Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Time Frame Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.
Arm/Group Title PDGFRα Mutation Positive and Negative (Wild-Type)
Hide Arm/Group Description:
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 and that did not have a PDGFRα mutation.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
5.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      3/14 (21.43%)    
Gastrointestinal disorders     
Abdominal pain  1  1/7 (14.29%)  1 1/14 (7.14%)  1
Ileus  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations     
Staphylococcal infection  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal stromal tumour  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders     
Syncope  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PDGFRα Mutation Positive PDGFRα Mutation Negative (Wild-Type)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      13/14 (92.86%)    
Endocrine disorders     
Hypothyroidism  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Eye disorders     
Conjunctival pallor  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  2/7 (28.57%)  2 0/14 (0.00%)  0
Abdominal mass  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Abdominal pain  1  1/7 (14.29%)  1 4/14 (28.57%)  9
Ascites  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Constipation  1  2/7 (28.57%)  2 2/14 (14.29%)  3
Diarrhoea  1  1/7 (14.29%)  1 1/14 (7.14%)  1
Dysphagia  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Nausea  1  1/7 (14.29%)  1 4/14 (28.57%)  5
Upper gastrointestinal haemorrhage  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Vomiting  1  0/7 (0.00%)  0 1/14 (7.14%)  2
General disorders     
Asthenia  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Chest discomfort  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Disease progression  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Fatigue  1  4/7 (57.14%)  6 5/14 (35.71%)  7
Influenza like illness  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Mucosal inflammation  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Non-cardiac chest pain  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Oedema peripheral  1  2/7 (28.57%)  3 2/14 (14.29%)  2
Pyrexia  1  1/7 (14.29%)  1 1/14 (7.14%)  1
Infections and infestations     
Bacterial infection  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Nasopharyngitis  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Oral herpes  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/7 (0.00%)  0 3/14 (21.43%)  5
Investigations     
Aspartate aminotransferase increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Blood albumin increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Blood alkaline phosphatase increased  1  1/7 (14.29%)  1 1/14 (7.14%)  2
Blood bilirubin increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Blood calcium increased  1  1/7 (14.29%)  2 0/14 (0.00%)  0
Blood lactate dehydrogenase increased  1  0/7 (0.00%)  0 1/14 (7.14%)  2
Blood phosphorus decreased  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Blood potassium decreased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Blood pressure increased  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Breath sounds abnormal  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Gamma-glutamyltransferase increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Haematocrit increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Haemoglobin increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Red blood cell count increased  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Waist circumference increased  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Weight decreased  1  0/7 (0.00%)  0 2/14 (14.29%)  3
Metabolism and nutrition disorders     
Decreased appetite  1  2/7 (28.57%)  2 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/7 (0.00%)  0 1/14 (7.14%)  2
Back pain  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Muscle spasms  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal chest pain  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Myalgia  1  0/7 (0.00%)  0 1/14 (7.14%)  2
Pain in extremity  1  1/7 (14.29%)  1 1/14 (7.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone neoplasm  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Nervous system disorders     
Headache  1  0/7 (0.00%)  0 4/14 (28.57%)  6
Neuralgia  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Psychiatric disorders     
Tearfulness  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/7 (0.00%)  0 2/14 (14.29%)  4
Dyspnoea  1  1/7 (14.29%)  1 1/14 (7.14%)  1
Productive cough  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Respiratory depression  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/7 (14.29%)  1 0/14 (0.00%)  0
Erythema  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Hyperhidrosis  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Rash  1  1/7 (14.29%)  4 0/14 (0.00%)  0
Vascular disorders     
Hypertension  1  0/7 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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 and trial terminated due to poor accrual.
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
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 )
First Submitted: March 14, 2011
First Posted: March 16, 2011
Results First Submitted: November 18, 2016
Results First Posted: January 16, 2017
Last Update Posted: March 9, 2017