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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01256567
First received: December 7, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 patients with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab DP in combination with docetaxel.


Condition Intervention Phase
Breast Cancer
Metastatic Breast Cancer
Biological: Ramucirumab
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product in Patients With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: Approximately 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum Anti-IMC-1121B Antibody Assessment (immunogenicity) [ Time Frame: Prior to infusion in Cycles 1, 2, 3, 4 and 5 ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) of ramucirumab [ Time Frame: Cycles 1-5 ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of ramucirumab [ Time Frame: Cycles 1-5 ] [ Designated as safety issue: No ]
  • Half life (t 1/2) of ramucirumab [ Time Frame: Cycles 1-5 ] [ Designated as safety issue: No ]
  • Clearance (Cl) of ramucirumab [ Time Frame: Cycles 1-5 ] [ Designated as safety issue: No ]
  • Steady State Volume of Distribution (Vss) of ramucirumab [ Time Frame: Cycles 1-5 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ramucirumab and docetaxel combination Biological: Ramucirumab
Ramucirumab administered as an I.V. infusion at a dose of 10 mg/kg every 3 weeks.
Other Names:
  • IMC-1121B
  • LY3009806
Drug: Docetaxel
Docetaxel administered by I.V. infusion at a dose of 75 mg/m2 every 3 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is Japanese
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • The patient has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent
  • The patient has measurable and/or non-measurable disease
  • The patients' primary and/or metastatic tumor is HER2-negative
  • The patient received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to the study
  • The patient received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to the study
  • The patient completed all prior radiotherapy ≥ 3 weeks prior to the study registration date
  • The patient 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 patient's left ventricular ejection fraction (LVEF) is within normal ranges
  • The patient has adequate hematologic, hepatic, and coagulation function.
  • Eligible patients 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

Exclusion Criteria:

  • The patient has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm
  • The patient has a known sensitivity to docetaxel
  • The patient has a known sensitivity to agents of similar biologic composition as ramucirumab
  • The patient has a history of chronic diarrheal disease within 6 months prior to the study registration date
  • The patient has received irradiation to a major bone marrow area within 30 days prior to the study registration date
  • The patient has received any experimental agents within 4 weeks prior to the study registration date
  • The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
  • The patient has Grade 3-4 bleeding within 3 months prior to the study registration date
  • The patient has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy
  • The patient has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders
  • The patient has brain metastases
  • The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness
  • The patient is pregnant or lactating
  • The patient has not fully recovered from effects of prior chemotherapy
  • The patient has undergone major surgery within 28 days prior to the study registration date
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256567

Locations
Japan
ImClone Investigational Site
Hidaka, Japan, 350-1298
ImClone Investigational Site
Matsuyama, Japan, 790-0007
Imclone Investigational Site
Nagoya, Japan, 464-8681
ImClone Investigational Site
Osaka, Japan, 540-0006
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01256567     History of Changes
Other Study ID Numbers: 14200, CP12-1028, I4T-IE-JVBX
Study First Received: December 7, 2010
Last Updated: August 19, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014