Trial Outcomes & Findings for A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (NCT NCT01316263)

NCT ID: NCT01316263

Last Updated: 2017-03-09

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-03-09

Participant Flow

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

Participant milestones

Measure	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.
Overall Study STARTED	7	14
Overall Study Received Any Study Drug	7	14
Overall Study COMPLETED	7	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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 n=21 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 7.90 • n=5 Participants	48.9 years STANDARD_DEVIATION 9.11 • n=7 Participants	54.2 years STANDARD_DEVIATION 11.48 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Spain	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Poland	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Belgium	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status(ECOG PS) ECOG PS =0	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status(ECOG PS) ECOG PS =1	4 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status(ECOG PS) ECOG PS ≥2	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Type of Cancer-Gastrointestinal Stromal Tumor	7 participants n=5 Participants	14 participants n=7 Participants	21 participants n=5 Participants
Histology-Cell Type Epitheloid Cell	6 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants
Histology-Cell Type Spindle Cell	0 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants
Histology-Cell Type Mixed/Combined	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Histology-Cell Type Other-unspecified	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Initial T Classification Staging at Diagnosis Tis	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Initial T Classification Staging at Diagnosis T2	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Initial T Classification Staging at Diagnosis T3	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Initial T Classification Staging at Diagnosis T4	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Initial T Classification Staging at Diagnosis TX	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Initial T Classification Staging at Diagnosis Missing	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Initial N Classification Staging at Diagnosis N0	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Initial N Classification Staging at Diagnosis N1	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Initial N Classification Staging at Diagnosis Missing	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Initial M Stage at Diagnosis M0	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Initial M Stage at Diagnosis M1	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Initial M Stage at Diagnosis MX	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Initial M Stage at Diagnosis Missing	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Current T Classification Staging T0	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Current T Classification Staging T3	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Current T Classification Staging T4	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Current T Classification Staging TX	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Current T Classification Staging Unknown	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Current T Classification Staging Missing	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Current N Classification Staging N0	5 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants
Current N Classification Staging N1	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Current N Classification Staging N2	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Current N Classification Staging Missing	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Current M Classification Staging M1	6 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants
Current M Classification Staging Missing	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All participants who received any study drug.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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.
Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks	42.9 percentage of participants Interval 12.9 to 77.5	14.3 percentage of participants Interval 2.6 to 38.5

SECONDARY outcome

Timeframe: Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks

Population: All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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.
Progression-Free Survival (PFS)	32.1 weeks Interval 5.0 to 35.9	6.1 weeks Interval 5.7 to 6.3

SECONDARY outcome

Timeframe: Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up

Population: All participants who received any study drug.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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.
Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]	0 percentage of participants No participant achieved CR or PR.	0 percentage of participants No participant achieved CR or PR.

SECONDARY outcome

Timeframe: Date of first dose of study drug to the date of death from any cause up to 57.3 weeks

Population: All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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 Survival (OS)	NA weeks Interval 10.9 to Median and 90% Confidence Interval upper limit were not evaluable due to high number of censored participants.	24.9 weeks Interval 14.4 to 49.1

SECONDARY outcome

Timeframe: Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up

Population: All participants who received any study drug.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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.
Number of Participants With Adverse Events (AE) and Participants Who Died SAEs	2 participants	3 participants
Number of Participants With Adverse Events (AE) and Participants Who Died AEs	7 participants	13 participants
Number of Participants With Adverse Events (AE) and Participants Who Died Died Due to AE	0 participants	1 participants
Number of Participants With Adverse Events (AE) and Participants Who Died Died Due to Disease Progression	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to 35.9 weeks

Population: All participants who received any study drug.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=7 Participants 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) n=14 Participants 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.
Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]	71.4 percentage of participants Interval 34.1 to 94.7	28.6 percentage of participants Interval 10.4 to 54.0

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 and 3 (14-day cycles)

Population: 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.

Outcome measures

Measure	PDGFRα Mutation Positive n=3 Participants 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.
Maximum Concentration (Cmax) Day 1 Cycle 1 (n=2)	392.9 nanograms per milliliter (ng/mL) Interval 314.0 to 471.8	—
Maximum Concentration (Cmax) Day 1 Cycle 3 (n=1)	483.9 nanograms per milliliter (ng/mL) Individual values are reported when n \<2.	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 and 3 (14-day cycles)

Population: Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 and 3 (14-day cycles)

Population: Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 and 3 (14-day cycles)

Population: Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Cycles 1 and 3 (14-day cycles)

Population: Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)

Population: All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.

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.

Outcome measures

Measure	PDGFRα Mutation Positive n=19 Participants 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.
Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results	5.3 percentage of participants	—

Adverse Events

PDGFRα Mutation Positive

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

PDGFRα Mutation Negative (Wild-Type)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	PDGFRα Mutation Positive n=7 participants at risk 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) n=14 participants at risk 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.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Ileus	0.00% 0/7	7.1% 1/14 • Number of events 1
Infections and infestations Staphylococcal infection	14.3% 1/7 • Number of events 1	0.00% 0/14
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/7	7.1% 1/14 • Number of events 1
Nervous system disorders Syncope	14.3% 1/7 • Number of events 1	0.00% 0/14

Other adverse events

Measure	PDGFRα Mutation Positive n=7 participants at risk 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) n=14 participants at risk 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.
Endocrine disorders Hypothyroidism	14.3% 1/7 • Number of events 1	0.00% 0/14
Eye disorders Conjunctival pallor	0.00% 0/7	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Abdominal discomfort	28.6% 2/7 • Number of events 2	0.00% 0/14
Gastrointestinal disorders Abdominal mass	0.00% 0/7	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1	28.6% 4/14 • Number of events 9
Gastrointestinal disorders Ascites	0.00% 0/7	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2	14.3% 2/14 • Number of events 3
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Dysphagia	14.3% 1/7 • Number of events 1	0.00% 0/14
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1	28.6% 4/14 • Number of events 5
Gastrointestinal disorders Upper gastrointestinal haemorrhage	14.3% 1/7 • Number of events 1	0.00% 0/14
Gastrointestinal disorders Vomiting	0.00% 0/7	7.1% 1/14 • Number of events 2
General disorders Asthenia	0.00% 0/7	7.1% 1/14 • Number of events 1
General disorders Chest discomfort	14.3% 1/7 • Number of events 1	0.00% 0/14
General disorders Disease progression	0.00% 0/7	7.1% 1/14 • Number of events 1
General disorders Fatigue	57.1% 4/7 • Number of events 6	35.7% 5/14 • Number of events 7
General disorders Influenza like illness	14.3% 1/7 • Number of events 1	0.00% 0/14
General disorders Mucosal inflammation	0.00% 0/7	7.1% 1/14 • Number of events 1
General disorders Non-cardiac chest pain	0.00% 0/7	7.1% 1/14 • Number of events 1
General disorders Oedema peripheral	28.6% 2/7 • Number of events 3	14.3% 2/14 • Number of events 2
General disorders Pyrexia	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 1
Infections and infestations Bacterial infection	14.3% 1/7 • Number of events 1	0.00% 0/14
Infections and infestations Nasopharyngitis	0.00% 0/7	7.1% 1/14 • Number of events 1
Infections and infestations Oral herpes	14.3% 1/7 • Number of events 1	0.00% 0/14
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/7	21.4% 3/14 • Number of events 5
Investigations Aspartate aminotransferase increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Blood albumin increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Blood alkaline phosphatase increased	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 2
Investigations Blood bilirubin increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Blood calcium increased	14.3% 1/7 • Number of events 2	0.00% 0/14
Investigations Blood lactate dehydrogenase increased	0.00% 0/7	7.1% 1/14 • Number of events 2
Investigations Blood phosphorus decreased	14.3% 1/7 • Number of events 1	0.00% 0/14
Investigations Blood potassium decreased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Blood pressure increased	14.3% 1/7 • Number of events 1	0.00% 0/14
Investigations Breath sounds abnormal	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Gamma-glutamyltransferase increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Haematocrit increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Haemoglobin increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Red blood cell count increased	0.00% 0/7	7.1% 1/14 • Number of events 1
Investigations Waist circumference increased	14.3% 1/7 • Number of events 1	0.00% 0/14
Investigations Weight decreased	0.00% 0/7	14.3% 2/14 • Number of events 3
Metabolism and nutrition disorders Decreased appetite	28.6% 2/7 • Number of events 2	7.1% 1/14 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7	7.1% 1/14 • Number of events 2
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7	7.1% 1/14 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7	7.1% 1/14 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	14.3% 1/7 • Number of events 1	0.00% 0/14
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7	7.1% 1/14 • Number of events 2
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	14.3% 1/7 • Number of events 1	0.00% 0/14
Nervous system disorders Headache	0.00% 0/7	28.6% 4/14 • Number of events 6
Nervous system disorders Neuralgia	0.00% 0/7	7.1% 1/14 • Number of events 1
Psychiatric disorders Tearfulness	0.00% 0/7	7.1% 1/14 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7	14.3% 2/14 • Number of events 4
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Number of events 1	7.1% 1/14 • Number of events 1
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7	7.1% 1/14 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/7	7.1% 1/14 • Number of events 1
Skin and subcutaneous tissue disorders Dermatitis acneiform	14.3% 1/7 • Number of events 1	0.00% 0/14
Skin and subcutaneous tissue disorders Erythema	0.00% 0/7	7.1% 1/14 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7	7.1% 1/14 • Number of events 1
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 4	0.00% 0/14
Vascular disorders Hypertension	0.00% 0/7	7.1% 1/14 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER