Clinical trial NCT01256567: A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 7
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to data cut off (approximately 48.3 weeks)
Secondary outcomes:
measure: Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)
timeFrame: Baseline up to data cut off (approximately 48.3 weeks)
measure: Maximum Concentration (Cmax) of Ramucirumab
timeFrame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
measure: Area Under the Curve (AUC) of Ramucirumab
timeFrame: Day 1 of Cycles 1 and 4 (cycle=21 days)
measure: Half Life (t 1/2) of Ramucirumab
timeFrame: Day 1 of Cycles 1 and 4 (cycle=21 days)
measure: Clearance (Cl) of Ramucirumab
timeFrame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
measure: Steady State Volume of Distribution (Vss) of Ramucirumab
timeFrame: Day 1 of Cycle 1 and 4 (cycle=21 days)
Other outcomes:
Locations:
city: Hidaka
country: Japan
facility: ImClone Investigational Site
city: Matsuyama
country: Japan
facility: ImClone Investigational Site
city: Nagoya
country: Japan
facility: Imclone Investigational Site
city: Osaka
country: Japan
facility: ImClone Investigational Site
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: