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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-MC-JVDU | Other Identifier | Eli Lilly and Company |
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Study terminated due to inadequate PK profile associated with the subcutaneous formulation.
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The purpose of this study in participants with advanced cancer is to learn more about the safety of ramucirumab when given by injection under the skin (subcutaneous injection). The study will also measure how much ramucirumab gets into the bloodstream and how long it takes the body to get rid of it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab | Experimental | Participants received starting dose of 700 milligram (mg) ramucirumab loading dose (LD) subcutaneously (SC) followed, a week later, by 350 mg ramucirumab maintenance dose (MD) administered SC once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab | PK: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days. | Cycle (C) 1 Day (D) 1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose |
| PK: Maximum Concentration (Cmax) of Ramucirumab | PK: Cmax of Ramucirumab was evaluated. | C1D1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose |
| PK: Serum Trough Concentration (Ctrough) of Ramucirumab | Ctrough of Ramucirumab was evaluated. | C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti-Ramucirumab Antibodies | Percentage of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted). |
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Inclusion Criteria:
Have evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
In the judgment of the investigator, be an appropriate candidate for experimental therapy and:
For Cohort A only: Have exhausted all anticancer treatments with proven clinical benefit OR
For Cohorts B and C only: Must have one of the three conditions below:
Eastern Cooperative Oncology Group performance status score of 0 or 1.
Have discontinued all previous treatments for cancer with adequate wash-out period and recovered from the acute effects of therapy.
Have adequate hematologic, hepatic, and renal functions and electrolytes.
Males and females of child-bearing potential must agree to use highly effective contraceptive methods during study treatment and for at least 84 days/12 weeks following the last dose of study drug.
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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Oncology Hematology West |
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| Label | URL |
|---|---|
| A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer | View source |
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Completers included participants who had progressive disease, off protocol therapy due to toxicity and having completed the short-term follow-up, death due to any cause.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab | Participants received starting dose of 700 milligram (mg) ramucirumab loading dose (LD) subcutaneously (SC) followed, a week later, by 350 mg ramucirumab maintenance dose (MD) administered SC once a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab | Participants received starting dose of 700 mg ramucirumab LD, SC followed, a week later, by 350 mg ramucirumab MD administered SC once a week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab | PK: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Cycle (C) 1 Day (D) 1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose |
|
Up To 40 Days
All randomized participants who received at least 1 dose of study drug.
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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 | Participants received starting dose of 700 mg ramucirumab LD, SC followed, a week later, by 350 mg ramucirumab MD administered SC once a week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
Study was terminated due to low likelihood of achieving a relevant therapeutic exposure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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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 | Feb 26, 2021 | Mar 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2021 | Mar 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose |
| Number of Participants With Injection Site Reactions (ISRs) | The number of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Cycle 1, Cycle 2, Cycle 3: D1, D8, D15, D22: 5-15 min, 60 min post injection; C1D2: 24 hours (h) post injection; C1D4 (± 1 day) |
| Omaha |
| Nebraska |
| 68130 |
| United States |
| Levine Cancer Institute- Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| Kindai University Hospital | Osaka Sayama-shi | Osaka | 589 8511 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PK: Maximum Concentration (Cmax) of Ramucirumab | PK: Cmax of Ramucirumab was evaluated. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | C1D1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose |
|
|
|
| Primary | PK: Serum Trough Concentration (Ctrough) of Ramucirumab | Ctrough of Ramucirumab was evaluated. | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose |
|
|
|
| Secondary | Percentage of Participants With Anti-Ramucirumab Antibodies | Percentage of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted). | Zero participants were analyzed. Data not collected. | Posted | C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose |
|
|
| Secondary | Number of Participants With Injection Site Reactions (ISRs) | The number of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment. | Posted | Number | participants | Cycle 1, Cycle 2, Cycle 3: D1, D8, D15, D22: 5-15 min, 60 min post injection; C1D2: 24 hours (h) post injection; C1D4 (± 1 day) |
|
|
|
| 1 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| C2D1 |
|
|
| C2D8 |
|
|
| C3D1 |
|
|