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| ID | Type | Description | Link |
|---|---|---|---|
| I4C-MC-JTBF | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of Emibetuzumab will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of Emibetuzumab and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs. The average amount of time on study is expected to be about 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emibetuzumab + Ramucirumab (Part A) | Experimental | Part A: Dose escalation (750mg, 2000mg) of Emibetuzumab administered intravenously (IV), on days 1 and 15 every 28 day cycle in combination with a fixed dose of 8mg/kg ramucirumab administered IV on Days 1 and 15 every 28 day cycle. |
|
| Emibetuzumab + Ramucirumab (Part B) | Experimental | Part B: Recommended 750mg Emibetuzumab dose from Part A to be administered IV, on days 1 and 15 every 28 day cycle in combination with a fixed dose of 8mg/kg ramucirumab administered IV on Days 1 and 15 every 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emibetuzumab | Drug | Administered Intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | DLT is defined as an adverse event during Cycle1 that is possibly, probably, or definitely related to treatment with Emibetuzumab in combination with fixed regimen of Ramucirumab & fulfills any 1 of the following criterion using NCI CTCAE Version 4.03: Grade 3 non-hematological toxicity. Exceptions will be made for:Nausea, vomiting, diarrhea, constipation, or skin rash that persists for ≤3 days following appropriate supportive care intervention. Grade 3 hypertension in which systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg persist <7 days after intensified antihypertensive therapy is initiated. Grade 4 hematological toxicity of ≥7 days duration. ≥Grade 3 thrombocytopenia with ≥Grade 2 bleeding. Any febrile neutropenia. Any other significant toxicity deemed by the primary investigator & Lilly clinical research personnel to be dose-limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of participant from study Cycle1). | Baseline through Cycle 1 (28 day cycle) |
| Part B: Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | ORR is the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Baseline through Measured Progressive Disease or Death (Up to 17 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab. | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose |
| Part B: Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) (Disease Control Rate [DCR]) |
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Inclusion Criteria:
Participants must have histological or cytological confirmed diagnosis of the following tumor types that is advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate participant for experimental therapy
Have at least 1 measurable lesion outside of the central nervous system (CNS) whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Availability of a tumor sample taken after progression on the most recent line of systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.
Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale in Part A and ≤ 1 on the ECOG scale in Part B.
Have adequate organ function.
Routine urinalysis showing ≤1+ protein or protein/creatinine ratio <0.5. For proteinuria ≥2+ or urine protein/creatinine ratio ≥0.5, 24-hour urine must be collected and the level must be <1 gram of protein in 24 hours for subject enrollment.
Have discontinued all previous cancer therapies and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 halflives prior to study enrollment, whichever is shorter, and recovered from the acute effects for therapy.
Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 8 weeks (2 cycles) of treatment.
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for at least 3 months following the last dose of study drug. Females with childbearing potential must have had a negative serum pregnancy test 7 days before the first dose of study drug and must not be breast-feeding.
Exclusion Criteria:
Have serious pre-existing medical conditions (at the discretion of the investigator, such as severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation).
Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
Participant has experienced any arterial thromboembolic event (ATE), including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, within 6 months prior to receiving study drugs.
Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolic event during the 3 months prior to receiving study drugs.
Are receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that they are on low-molecular weight heparin or oral factor Xa inhibitors.
The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted.
Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to receiving study drugs.
Have a history of GI perforation and/or fistulae within 6 months prior to receiving study drugs.
Have congestive heart failure (CHF) New York Heart Association class ≥3 or symptomatic or poorly controlled cardiac arrhythmia.
Have undergone major surgery within 28 days prior to receiving study drugs.
Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to receiving study drugs.
Have a known active fungal, bacterial, and/or known viral infection. Hepatocellular cancer participants with chronic viral (B or C) hepatitis are eligible if they retain adequate liver function.
Have liver cirrhosis with a Child-Pugh Stage of B or C.
Have symptomatic CNS malignancy (with the exception of medulloblastoma) or metastasis.
Have corrected QT (QTc) interval of >470 milliseconds on screening electrocardiogram (ECG).
Have received previous treatment with ramucirumab or Emibetuzumab, except for participants enrolled in cohort B1 (Gastric or GEJ adenocarcinoma) and B4 (non- small cell lung cancer) who may have received previous ramucirumab treatment.
Known hypersensitivity to any of the treatment components of ramucirumab or Emibetuzumab.
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
Are pregnant or breastfeeding.
For Part B4 (non-small cell lung cancer) only:
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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 |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114-3117 | United States | ||
| Dana Farber Cancer Institute |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY2875358 in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer | View source |
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Two part study, Part A with 2 cohorts (750 milligram (mg), 2000mg) & Part B with four tumor specific cohorts (gastric, hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC)).
Part A: Completers are those who have completed one cycle of treatment. Part B: Completers are those who 1)Have measurable disease at baseline and at least one post-baseline tumor assessment; and 2) Were treated until PD or death, or discontinued due to an AE and completed the required follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - 750 mg Emibetuzumab | Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| FG001 | Part A - 2000 mg Emibetuzumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2015 | Jan 30, 2019 |
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| Ramucirumab | Drug | Administered Intravenously (IV) |
|
|
DCR is the proportion of participants who exhibit a SD or confirmed CR or PR relative to baseline. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Progressive disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Baseline through Measured Progressive Disease (Up to 17 months) |
| Part B: Progression Free Survival (PFS) | PFS was defined as the time from the date of first dose of study drug until first observation of objective (radiographically documented) PD as defined by RECIST v1.1 or death from any cause, whichever comes first. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Baseline to Measured Progressive Disease or Death (Up to 17 Months) |
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) From Time Zero to Tlast of Emibetuzumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) from time zero to tlast of Emibetuzumab. | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose |
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab. | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose |
| Number of Participants With Treatment Emergent Anti-Emibetuzumab Antibodies | Participants were considered as treatment-emergent anti drug antibodies (TE ADA) positive if there is a ≥4-fold increase from baseline when ADAs were detected at baseline. If no ADAs were detected at baseline, TE ADA were defined as those with a titer 2 fold (1 dilution) greater than the minimum required dilution (MRD) of the screening assay (1:4 for anti-emibetuzumab antibodies). | Baseline through 46 Months |
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab. | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose |
| Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies | Participants were considered as treatment-emergent anti drug antibodies (TE ADA) positive if there is a ≥4-fold increase from baseline when ADAs were detected at baseline. If no ADAs were detected at baseline, TE ADA were defined as those with a titer 2 fold (1 dilution) greater than the minimum required dilution (MRD) of the screening assay (1:10 for anti-ramucirumab antibodies). | Baseline through 46 Months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| FG002 | Part B - Gastric | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| FG003 | Part B - HCC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| FG004 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| FG005 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A - 750 mg Emibetuzumab | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG001 | Part A - 2000 mg Emibetuzumab | Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG002 | Part B - Gastric | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG003 | Part B - HCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG004 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG005 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| BG006 | 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 | No |
| ||||||||||
| Ethnicity (NIH/OMB) | All participants with baseline ethnicity data. | Count of Participants | Participants | No |
| |||||||||
| Race (NIH/OMB) | All randomized participants with baseline race data. | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | DLT is defined as an adverse event during Cycle1 that is possibly, probably, or definitely related to treatment with Emibetuzumab in combination with fixed regimen of Ramucirumab & fulfills any 1 of the following criterion using NCI CTCAE Version 4.03: Grade 3 non-hematological toxicity. Exceptions will be made for:Nausea, vomiting, diarrhea, constipation, or skin rash that persists for ≤3 days following appropriate supportive care intervention. Grade 3 hypertension in which systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg persist <7 days after intensified antihypertensive therapy is initiated. Grade 4 hematological toxicity of ≥7 days duration. ≥Grade 3 thrombocytopenia with ≥Grade 2 bleeding. Any febrile neutropenia. Any other significant toxicity deemed by the primary investigator & Lilly clinical research personnel to be dose-limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of participant from study Cycle1). | All participants who received at least one dose of Emibetuzumab in Part A & Part B. | Posted | Count of Participants | Participants | No | Baseline through Cycle 1 (28 day cycle) |
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| Primary | Part B: Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | ORR is the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who received at least one dose of Emibetuzumab in Part B. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Measured Progressive Disease or Death (Up to 17 months) |
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| Secondary | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab | Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab. | All participants who received at least one dose of Emibetuzumab and had evaluable PK samples in Part A & Part B. Per protocol analysis was performed per each dose irrespective of the study parts. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (µg/mL) | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose |
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| Secondary | Part B: Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) (Disease Control Rate [DCR]) | DCR is the proportion of participants who exhibit a SD or confirmed CR or PR relative to baseline. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Progressive disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who received at least one dose of Emibetuzumab in Part B. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Measured Progressive Disease (Up to 17 months) |
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| Secondary | Part B: Progression Free Survival (PFS) | PFS was defined as the time from the date of first dose of study drug until first observation of objective (radiographically documented) PD as defined by RECIST v1.1 or death from any cause, whichever comes first. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who received at least one dose of Emibetuzumab in part B. Censored participants in Part B- Gastric = 4; Part B - HCC = 15; Part B - RCC = 7; Part - B NSCLC = 4; | Posted | Median | 95% Confidence Interval | months | Baseline to Measured Progressive Disease or Death (Up to 17 Months) |
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| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) From Time Zero to Tlast of Emibetuzumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) from time zero to tlast of Emibetuzumab. | All participants who received at least one dose of Emibetuzumab and had evaluable PK samples in Part A & Part B. Per protocol, analysis was performed per each dose irrespective of study parts. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram * hour per milliliter(µg*h/mL) | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h, 334h, 335h and 336h Post dose |
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| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab | Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab. | Noncompartmental PK parameters were not generated for Ramucirumab due to inadequate PK sampling. | Posted | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose |
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| Secondary | Number of Participants With Treatment Emergent Anti-Emibetuzumab Antibodies | Participants were considered as treatment-emergent anti drug antibodies (TE ADA) positive if there is a ≥4-fold increase from baseline when ADAs were detected at baseline. If no ADAs were detected at baseline, TE ADA were defined as those with a titer 2 fold (1 dilution) greater than the minimum required dilution (MRD) of the screening assay (1:4 for anti-emibetuzumab antibodies). | All participants who received at least one dose of Emibetuzumab and had evaluable immunogenicity samples. | Posted | Count of Participants | Participants | No | Baseline through 46 Months |
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| Secondary | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab. | Noncompartmental PK parameters were not generated for Ramucirumab due to inadequate PK sampling. | Posted | Cycle 1: Day1 Predose, End of infusion, 3 Hours (h), 5h, 8h, 21h, 168h and 336h Post dose |
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| Secondary | Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies | Participants were considered as treatment-emergent anti drug antibodies (TE ADA) positive if there is a ≥4-fold increase from baseline when ADAs were detected at baseline. If no ADAs were detected at baseline, TE ADA were defined as those with a titer 2 fold (1 dilution) greater than the minimum required dilution (MRD) of the screening assay (1:10 for anti-ramucirumab antibodies). | All participants who received at least one dose of ramucirumab and had evaluable immunogenicity samples. | Posted | Count of Participants | Participants | No | Baseline through 46 Months |
|
Up to 46 months
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A - 750 mg Emibetuzumab | Participants received 8 milligram per kilogram (mg/kg) Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Part A - 2000 mg Emibetuzumab | Participants received 8 mg/kg Ramucirumab followed by 2000 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Part B - Gastric | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 3 | 16 | 4 | 16 | 15 | 16 |
| EG003 | Part B - HCC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 4 | 45 | 19 | 45 | 45 | 45 |
| EG004 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 1 | 15 | 5 | 15 | 15 | 15 |
| EG005 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750 mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. | 1 | 15 | 3 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breakthrough pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rubber sensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Paracentesis | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release & can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to sponsor for review. Sponsor can extend disclosure restriction for additional 60 days to protect intellectual property interests. If PI is unwilling to delay then PI shall remove the information that sponsor believes would jeopardize its IP interests
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2014 | Jan 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599789 | emibetuzumab |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
|
|
|
|
| OG002 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG003 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
|
|
|
| OG002 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG003 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
|
|
| OG003 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
|
|
|
| OG003 | Part B - HCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG004 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG005 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
|
|
| OG003 | Part B - HCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG004 | Part B - RCC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
| OG005 | Part B - NSCLC | Participants received 8 mg/kg Ramucirumab followed by 750mg Emibetuzumab given as intravenous (IV) infusion on days 1 and 15 of 28 days cycle. |
|
|