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| ID | Type | Description | Link |
|---|---|---|---|
| CP15-1008 | Other Identifier | ImClone, LLC | |
| I5B-IE-JGDH | Other Identifier | Eli Lilly and Company | |
| 2010-022560-12 | EudraCT Number |
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Trial terminated strategically due to poor accrual.
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The purpose of this study is to evaluate the tumor response of stable disease (SD), partial response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα) mutations and patients with GIST not harboring PDGFRα mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDGFRα mutation negative | Experimental | Participants with GIST with genotypes that do not have a PDGFRα mutation given 20 milligrams per kilogram (mg/kg) Olaratumab intravenously (IV) every 14 days. |
|
| PDGFRα mutation positive | Experimental | Participants with GIST with genotypes that have a PDGFRα mutation given 20 mg/kg Olaratumab IV every 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Biological | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
Not provided
Inclusion Criteria:
Participant has histologically or cytologically confirmed, unresectable and/or metastatic GIST
Participant has measurable disease
Participant has documented objective progression following, or intolerance to, treatment with both imatinib and sunitinib
Participant's Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2
Participant has either:
Participant has adequate hematologic, hepatic, renal and coagulation function
Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for at least 12 weeks after the last dose of IMC-3G3
Participant has a life expectancy of ≥ 3 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Chicago | Illinois | 60637 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28426120 | Derived | Wagner AJ, Kindler H, Gelderblom H, Schoffski P, Bauer S, Hohenberger P, Kopp HG, Lopez-Martin JA, Peeters M, Reichardt P, Qin A, Nippgen J, Ilaria RL, Rutkowski P. A phase II study of a human anti-PDGFRalpha monoclonal antibody (olaratumab, IMC-3G3) in previously treated patients with metastatic gastrointestinal stromal tumors. Ann Oncol. 2017 Mar 1;28(3):541-546. doi: 10.1093/annonc/mdw659. |
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Participants who were considered to have completed Stage 1 of the study discontinued due to progressive disease (PD) or died.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks |
| Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)] | 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. | Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up |
| Overall Survival (OS) | 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. | Date of first dose of study drug to the date of death from any cause up to 57.3 weeks |
| Number of Participants With Adverse Events (AE) and Participants Who Died | 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. | Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up |
| Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)] | 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. | Baseline up to 35.9 weeks |
| Maximum Concentration (Cmax) | Day 1 of Cycles 1 and 3 (14-day cycles) |
| Area Under the Curve (AUC) | Day 1 of Cycles 1 and 3 (14-day cycles) |
| Half Life (t½) | Day 1 of Cycles 1 and 3 (14-day cycles) |
| Clearance (CL) | Day 1 of Cycles 1 and 3 (14-day cycles) |
| Volume of Distribution at Steady State (Vss) | Day 1 of Cycles 1 and 3 (14-day cycles) |
| Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results | 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. | Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| ImClone Investigational Site | Edegem | B-2650 | Belgium |
| ImClone Investigational Site | Leuven | B-3000 | Belgium |
| ImClone Investigational Site | Bad Saarow | 15526 | Germany |
| ImClone Investigational Site | Berlin | 13125 | Germany |
| ImClone Investigational Site | Essen | 45122 | Germany |
| ImClone Investigational Site | Mannheim | 68167 | Germany |
| ImClone Investigational Site | Tübingen | 72076 | Germany |
| ImClone Investigational Site | Leiden | 2300 RC | Netherlands |
| ImClone Investigational Site | Warsaw | 02-781 | Poland |
| ImClone Investigational Site | Madrid | 28041 | Spain |
| ImClone Investigational Site | Madrid | 28050 | Spain |
| 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. |
| Received Any Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All participants who received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status(ECOG PS) | 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. | Number | participants |
| |||||||||||||||
| Type of Cancer-Gastrointestinal Stromal Tumor | Number | participants |
| ||||||||||||||||
| Histology-Cell Type | Number | participants |
| ||||||||||||||||
| Initial T Classification Staging at Diagnosis | 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. | Number | participants |
| |||||||||||||||
| Initial N Classification Staging at Diagnosis | Staging: N0=no regional lymph nodes metastasis; N1 to N3=Regional lymph node metastasis, higher number indicated greater involvement. | Number | participants |
| |||||||||||||||
| Initial M Stage at Diagnosis | 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. | Number | participants |
| |||||||||||||||
| Current T Classification Staging | 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. | Number | participants |
| |||||||||||||||
| Current N Classification Staging | Staging: N0=no regional lymph nodes metastasis; N1 to N3=Regional lymph node metastasis, higher number indicated greater involvement. | Number | participants |
| |||||||||||||||
| Current M Classification Staging | 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. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks | 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. | All participants who received any study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | 12 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | 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. | All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0. | Posted | Median | 90% Confidence Interval | weeks | Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)] | 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. | All participants who received any study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | 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. | All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4. | Posted | Median | 90% Confidence Interval | weeks | Date of first dose of study drug to the date of death from any cause up to 57.3 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AE) and Participants Who Died | 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. | All participants who received any study drug. | Posted | Number | participants | Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)] | 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. | All participants who received any study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to 35.9 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) | 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. | Posted | Mean | Full Range | nanograms per milliliter (ng/mL) | Day 1 of Cycles 1 and 3 (14-day cycles) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) | Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations. | Posted | Day 1 of Cycles 1 and 3 (14-day cycles) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Half Life (t½) | Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations. | Posted | Day 1 of Cycles 1 and 3 (14-day cycles) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) | Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations. | Posted | Day 1 of Cycles 1 and 3 (14-day cycles) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady State (Vss) | Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations. | Posted | Day 1 of Cycles 1 and 3 (14-day cycles) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results | 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. | All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data. | Posted | Number | percentage of participants | Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 7 | 7 | 7 | ||
| EG001 | 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. | 3 | 14 | 13 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctival pallor | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood albumin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Waist circumference increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tearfulness | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589393 | olaratumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Spain |
|
| Poland |
|
| Belgium |
|
| Netherlands |
|
| Germany |
|
| ECOG PS =1 |
|
| ECOG PS ≥2 |
|
| Spindle Cell |
|
| Mixed/Combined |
|
| Other-unspecified |
|
| T2 |
|
| T3 |
|
| T4 |
|
| TX |
|
| Missing |
|
| N1 |
|
| Missing |
|
| M1 |
|
| MX |
|
| Missing |
|
| T3 |
|
| T4 |
|
| TX |
|
| Unknown |
|
| Missing |
|
| N1 |
|
| N2 |
|
| Missing |
|
| Missing |
|
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. |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 1 Cycle 1 (n=2) |
| |||||
| Day 1 Cycle 3 (n=1) |
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