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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-0713 | Other Identifier | ImClone Systems | |
| I4T-IE-JVCC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the effect of concomitant ramucirumab on the pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.
Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to schedule will be replaced for the purpose of analysis; these participants may continue to receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles 1 and 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramucirumab (IMC-1121B) and docetaxel | Experimental | Cycle 1: docetaxel administered on Day 1 of 3-week cycle Cycle 2: ramucirumab and docetaxel administered on Day 1 of 3-week cycle Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle Extension Phase: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1 | Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion | |
| Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2 | Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion | |
| Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1 | Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion | |
| Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2 | Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). | Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug |
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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 | Ann Arbor | Michigan | 48109 | United States | ||
| ImClone Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of ramucirumab or docetaxel.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1 | All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 1. | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter/milligram | Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion |
|
|
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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 | All Participants | Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | 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 |
|---|---|
| D000096662 | Ramucirumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Docetaxel | Drug | docetaxel 75 milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of each 3-week cycle |
|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel | Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel | Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion |
| Detroit |
| Michigan |
| 48202 |
| United States |
| ImClone Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| ImClone Investigational Site | Huntersville | North Carolina | 28078 | United States |
| ImClone Investigational Site | Cleveland | Ohio | 44195 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2 | All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 2. | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter/milligram | Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion |
|
|
|
|
| Primary | Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1 | All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 1. | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter/milligram | Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion |
|
|
|
| Primary | Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2 | All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 2. | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter/milligram | Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion |
|
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). | All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment who had immunogenicity samples collected at the specified time points. | Number | participants | Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel | All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2. | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (mcg*h/mL) | Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion |
|
|
|
| Secondary | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel | All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2. | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (mcg/mL) | Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion |
|
|
|
| 11 |
| 22 |
| 20 |
| 22 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | 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 |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | 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.
| 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 |