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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-1028 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBX | Other Identifier | Eli Lilly and Company |
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The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab drug product (DP) in combination with docetaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramucirumab and docetaxel combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity. | Baseline up to data cut off (approximately 48.3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity) | The number of participants with a positive anti-IMC-1121B titer at any point during the study. | Baseline up to data cut off (approximately 48.3 weeks) |
| Maximum Concentration (Cmax) of Ramucirumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Hidaka | 350-1298 | Japan | |||
| ImClone Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab and Docetaxel Combination | Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks. Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab and Docetaxel Combination | Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks. Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Adverse Events | Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity. | All participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to data cut off (approximately 48.3 weeks) |
|
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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 | Ramucirumab and Docetaxel Combination | Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks. Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Docetaxel | Drug | Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks. |
|
Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided. |
| Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) |
| Area Under the Curve (AUC) of Ramucirumab | AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided. | Day 1 of Cycles 1 and 4 (cycle=21 days) |
| Half Life (t 1/2) of Ramucirumab | Day 1 of Cycles 1 and 4 (cycle=21 days) |
| Clearance (Cl) of Ramucirumab | Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided. | Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) |
| Steady State Volume of Distribution (Vss) of Ramucirumab | Day 1 of Cycle 1 and 4 (cycle=21 days) |
| Matsuyama |
| 790-0007 |
| Japan |
| Imclone Investigational Site | Nagoya | 464-8681 | Japan |
| ImClone Investigational Site | Osaka | 540-0006 | Japan |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Ramucirumab and Docetaxel Combination | Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks. Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks. |
|
|
| Secondary | Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity) | The number of participants with a positive anti-IMC-1121B titer at any point during the study. | All participants with evaluable antibody assessment data. | Posted | Number | participants | Baseline up to data cut off (approximately 48.3 weeks) |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Ramucirumab | Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided. | All participants with evaluable Cmax data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) |
|
|
|
| Secondary | Area Under the Curve (AUC) of Ramucirumab | AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided. | All participants with evaluable AUC data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliliter (mcg*day/mL) | Day 1 of Cycles 1 and 4 (cycle=21 days) |
|
|
|
| Secondary | Half Life (t 1/2) of Ramucirumab | All participants with evaluable t1/2 data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Day 1 of Cycles 1 and 4 (cycle=21 days) |
|
|
|
| Secondary | Clearance (Cl) of Ramucirumab | Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided. | All participants with evaluable clearance data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per hour (mL/hr) | Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) |
|
|
|
| Secondary | Steady State Volume of Distribution (Vss) of Ramucirumab | All participants with evaluable Vss data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters (L) | Day 1 of Cycle 1 and 4 (cycle=21 days) |
|
|
|
| 7 |
| 7 |
| 7 |
| 7 |
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myodesopsia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urine | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperkeratosis palmaris and plantaris | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |