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


Phase 1
20 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Adverse Events

Outcome Time Frame:

Approximately 4 months

Safety Issue:

Yes

Principal Investigator

Email: Clinicaltrials@ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Japan: Institutional Review Board

Study ID:

14200

NCT ID:

NCT01256567

Start Date:

December 2010

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms

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