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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
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This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORAb-066 0.1 mg/kg | Experimental | Participants will receive MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
| MORAb-066 0.3 mg/kg | Experimental | Participants will receive MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
| MORAb-066 1 mg/kg | Experimental | Participants will receive MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
| MORAb-066 2 mg/kg | Experimental | Participants will receive MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORAb-066 | Drug | MORAb-066 infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations. | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. |
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Inclusion Criteria:
Patients must meet the following criteria in order to be included in this clinical trial:
Histologically or cytologically confirmed diagnosis of breast, colorectal, pancreas, or NSCLC (adenocarcinoma) that is metastatic or unresectable for which there is no effective therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A).
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Subject has recovered (to Grade less than or equal to 1) from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions (described separately below).
Adequate organ system function less than or equal to 2 weeks prior to Day1, defined as follows:
Life expectancy of greater than or equal to 12 weeks.
Female patients of child-bearing potential (see Appendix C), and all male patients must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after their last MORAb-066 administration. A barrier method of contraception must be included.
Patients must be greater than or equal to 18 years of age.
Patients entering this study will be asked to provide archival tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, the subject will still be eligible for enrollment into the study.
Ability to understand the nature of this study and give written informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from trial entry:
Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of MORAb-066. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of MORAb-066 is required.
Any major surgery, chemotherapy, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed greater than or equal to 2 weeks).
Subject has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) less than or equal to 28 days or limited field radiation for palliation less than or equal to 14 days prior to starting study drug or has not recovered from side effects of such therapy.
Known intracranial involvement, leptomeningeal metastases or spinal cord compression due to disease.
Known allergy or hypersensitivity to monoclonal antibodies.
Known bleeding diathesis, such as factor deficiency, factor inhibitor, platelet disorder, or who are on active anticoagulation, or any dose of aspirin within 5 days prior to first dose of MORAb-066.
Known prior significant bleeding history.
Patients with ureteral stents or 3+ blood in the urine at baseline.
Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
Patients who received a previous mAb therapy and have evidence of an immune or allergic reaction or previously documented HAHA reaction.
A serious non-healing wound, active ulcer, or untreated bone fracture. An abdominal fistula or gastrointestinal perforation less than 6 months prior to treatment.
History of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) less than or equal to 1 month prior to study enrollment.
Subject has cardiac dysfunction including any of the following:
A serious active infection (bacterial or fungal) at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
Chronic inflammatory disorder(e.g., inflammatory bowel disease, active vasculitis).
Herbal preparations/medications must be discontinued 7 days prior to first dose of study drug (see Section 5.3.1).
Known diagnosis of human immunodeficiency virus, Hepatitis B or Hepatitis C.
History or current diagnosis of glomerulonephritis
History of clinically significant or current diagnosis of hematuria.
Women who are pregnant or lactating.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma City | Oklahoma | United States | ||||
A total of 27 participants were enrolled and treated in the study.
Participants took part in the study at 2 investigative sites in the United States from 19 June 2013 to 09 February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | MORAb-066 0.1 mg/kg | Participants received MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MORAb-066 3 mg/kg | Experimental | Participants will receive MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
| Cycle 1 (Cycle length=28 days) |
| Maximum Tolerated Dose (MTD) | The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. | Cycle 1 (Cycle length=28 days) |
| Cmax: Maximum Observed Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| t1/2: Terminal Elimination Phase Half-Life for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| Vd: Volume of Distribution for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| CL: Total Body Clearance for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
| Number of Participants With Best Overall Response (BOR) | BOR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target and non-target lesions is complete response (CR) or partial response (PR). CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non-pathological in size (less than 10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | Up to approximately 2 years 7 months |
| Number of Participants Positive for Antidrug Antibodies (ADA) | Up to approximately 2 years 7 months |
| Nashville |
| Tennessee |
| United States |
| MORAb-066 0.3 mg/kg |
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| FG002 | MORAb-066 1 mg/kg | Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| FG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| FG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
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| NOT COMPLETED |
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The safety analysis set included all participants who had received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | MORAb-066 0.1 mg/kg | Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| BG001 | MORAb-066 0.3 mg/kg | Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| BG002 | MORAb-066 1 mg/kg | Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| BG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| BG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| BG005 | 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations. | The safety analysis set was the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months) |
|
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| Secondary | Number of Participants With Dose Limiting Toxicity (DLT) | DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. | The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug. | Posted | Count of Participants | Participants | Cycle 1 (Cycle length=28 days) |
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| Secondary | Maximum Tolerated Dose (MTD) | The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. | The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug. | Posted | Number | mg/kg | Cycle 1 (Cycle length=28 days) |
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| Secondary | Cmax: Maximum Observed Serum Concentration for MORAb-066 | The pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Median | Full Range | hours | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | t1/2: Terminal Elimination Phase Half-Life for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | hours | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | hours*microgram/milliliter | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here,"Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | hour*microgram per milliliter | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | Vd: Volume of Distribution for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | liter | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | CL: Total Body Clearance for MORAb-066 | The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure. | Posted | Mean | Standard Deviation | liter per hour | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) |
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| Secondary | Number of Participants With Best Overall Response (BOR) | BOR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target and non-target lesions is complete response (CR) or partial response (PR). CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non-pathological in size (less than 10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | The efficacy analysis set was the group of participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to approximately 2 years 7 months |
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| Secondary | Number of Participants Positive for Antidrug Antibodies (ADA) | The ADA evaluable population was the participants who received at least one dose of study drug and had at least one post-baseline ADA sample. | Posted | Count of Participants | Participants | Up to approximately 2 years 7 months |
|
First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
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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 | MORAb-066 0.1 mg/kg | Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | MORAb-066 0.3 mg/kg | Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG002 | MORAb-066 1 mg/kg | Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. | 1 | 5 | 3 | 5 | 5 | 5 |
| EG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. | 2 | 7 | 4 | 7 | 7 | 7 |
| EG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. | 1 | 8 | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Colitis microscopic | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Local swelling | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Localised oedema | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Nodule | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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 |
|
| SAEs |
|
| MORAb-066 1 mg/kg |
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG002 | MORAb-066 1 mg/kg | Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
|
|
| OG003 | MORAb-066 2 mg/kg | Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| OG004 | MORAb-066 3 mg/kg | Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
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