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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Administered SC
Highlands Oncology Group
Fayetteville, Arkansas, United States
Oncology Hematology West
Omaha, Nebraska, United States
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab
PK: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days.
Time frame: 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.
Time frame: 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.
Time frame: C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose
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).
Time frame: 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.
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Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan
Time frame: 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)