Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.

Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m\^2) every 3 weeks.

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)

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.

A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

A Phase 1b Study of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product in Patients With Locally Advanced or Metastatic Breast Cancer

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.

The number of participants with a positive anti-IMC-1121B titer at any point during the study.

Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.

AUC from time zero to infinity (AUC\[0-inf\], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.

Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.

Eli Lilly and Company

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.

Ramucirumab and Docetaxel Combination

Between 20 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

Asian

American Indian or Alaska Native

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Race/Ethnicity, Customized

Japan

Region of Enrollment

Chief Medical Officer

Dose Limiting Toxicity (DLT) during Cycle 1

TEAE related to ramucirumab

SAE related to ramucirumab

TEAE of Grade ≥3 related to ramucirumab

TEAE resulting in ramucirumab discontinuation

TEAE with ramucirumab dose modification/delay

All participants who received at least 1 dose of study drug.

Number of Participants With Adverse Events

All participants with evaluable antibody assessment data.

Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)

Cmax at Cycle 1

Cmax,ss at Cycle 4 (n=6)

All participants with evaluable Cmax data at the specified time points.

Maximum Concentration (Cmax) of Ramucirumab

AUC(0-inf) at Cycle 1

AUC tau at Cycle 4 (n=6)

All participants with evaluable AUC data at the specified time points.

Area Under the Curve (AUC) of Ramucirumab

t1/2 at Cycle 1

t1/2 at Cycle 4 (n=6)

All participants with evaluable t1/2 data at the specified time points.

Half Life (t 1/2) of Ramucirumab

Clearance at Cycle 1

Clearance at steady state (Clss) at Cycle 4 (n=6)

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.

All participants with evaluable clearance data at the specified time points.

Clearance (Cl) of Ramucirumab

Vss at Cycle 1

Vss at Cycle 4 (n=6)

All participants with evaluable Vss data at the specified time points.

Steady State Volume of Distribution (Vss) of Ramucirumab

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.

Spots Global Cancer Trial Database for A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial