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

NCT01256567 | Completed Phase 1 Results DMC

• 3 other identifiers: 14200CP12-1028I4T-IE-JVBX
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

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

  Baseline up to data cut off (approximately 48.3 weeks)

• Maximum Concentration (Cmax) of Ramucirumab

  Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)

• Area Under the Curve (AUC) of Ramucirumab

  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

  Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)

Study Arms (1)

ramucirumab and docetaxel combination

EXPERIMENTAL

Biological: Ramucirumab; Drug: Docetaxel

Interventions

Ramucirumab BIOLOGICAL

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

Also known as: IMC-1121B, LY3009806

ramucirumab and docetaxel combination

Docetaxel DRUG

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

ramucirumab and docetaxel combination

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is Japanese
• The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent
• The participant has measurable and/or non-measurable disease
• The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative
• The participant received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to the study
• The participant received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to the study
• The participant completed all prior radiotherapy ≥ 3 weeks prior to the study registration date
• The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting ≥ 2 weeks prior to the study registration date
• The participant's left ventricular ejection fraction (LVEF) is within normal ranges
• The participant has adequate hematologic, hepatic, and coagulation function.
• Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

You may not qualify if:

• The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for \>3 years
• The participant has a known sensitivity to docetaxel
• The participant has a known sensitivity to agents of similar biologic composition as ramucirumab
• The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date
• The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date
• The participant has received any experimental agents within 4 weeks prior to the study registration date
• The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
• The participant has Grade 3-4 bleeding within 3 months prior to the study registration date
• The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy
• The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders
• The participant has brain metastases
• The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness
• The participant is pregnant or lactating
• The participant has not fully recovered from effects of prior chemotherapy
• The participant has undergone major surgery within 28 days prior to the study registration date

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

ImClone Investigational Site

Hidaka, 350-1298, Japan

Location

ImClone Investigational Site

Matsuyama, 790-0007, Japan

Location

Imclone Investigational Site

Nagoya, 464-8681, Japan

Location

ImClone Investigational Site

Osaka, 540-0006, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ramucirumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-05

Locations

JP (4)