Trial record 1 of 1 for:    CP20-0903
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Study of IMC-18F1 or Ramucirumab DP in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01234402
First received: November 3, 2010
Last updated: February 27, 2014
Last verified: February 2014

November 3, 2010
February 27, 2014
March 2011
October 2013   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
Progression-Free Survival (PFS) [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01234402 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: Yes ]
  • Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or IMC-18F1 [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or IMC-18F1 [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Area under the curve (AUC) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Terminal half-life (t½) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Clearance (Cl) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: No ]
    Cycles 1, 2, 3, 4, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Anti-Ramucirumab and Anti-IMC-18F1 Antibody Assessment [ Time Frame: Approximately 31 Months ] [ Designated as safety issue: Yes ]
    Prior to infusion in Cycles 1, 2, 3, 6, every 2 Cycles thereafter, and at 30 day follow-up
  • Overall Survival (OS) [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: Yes ]
  • Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or IMC-18F1 [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
    Prior to and 1.5 hours after the infusion in Cycles 1, 2, 3, 4, 6, and every 2 Cycles thereafter
  • Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or IMC-18F1 [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: No ]
    Prior to and 1.5 hours after the infusion in Cycles 1, 2, 3, 4, 6, and every 2 Cycles thereafter
  • Serum Antibody Assessment of Anti-Ramucirumab and Anti-IMC-18F1 [ Time Frame: Approximately 22 Months ] [ Designated as safety issue: Yes ]
    Prior to infusion in Cycles 1, 2, 3, 6, and every 2 Cycles thereafter
Not Provided
Not Provided
 
Study of IMC-18F1 or Ramucirumab DP in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy

An open-label, multicenter, randomized, Phase 2 trial in which patients with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or IMC-18F1 administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 patients will be randomized in a 1:1:1 ratio to either ramucirumab DP or IMC-18F1 in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.

Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: Ramucirumab DP

    10 mg/kg I.V.

    Day 1 of every-21-day cycle

    Other Names:
    • IMC-1121B
    • LY3009806
  • Biological: IMC-18F1

    12 mg/kg I.V.

    Days 1 and 8 of every-21-day cycle

    Other Names:
    • Icrucumab
    • LY3012212
  • Drug: Capecitabine

    1000 mg/m2 orally

    Twice a day for 14 days

  • Experimental: Ramucirumab DP + Capecitabine
    Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the patient.
    Interventions:
    • Biological: Ramucirumab DP
    • Drug: Capecitabine
  • Experimental: IMC-18F1 + Capecitabine
    Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the patient.
    Interventions:
    • Biological: IMC-18F1
    • Drug: Capecitabine
  • Active Comparator: Capecitabine*

    Crossover Study:

    * At the discretion of the investigator, patients will be eligible to receive either ramucirumab DP or IMC-18F1 in combination with capecitabine, after radiographic disease progression while on capecitabine. The investigator will decide which investigational product will be given.

    Cycles repeat every 21 days until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the patient.

    Intervention: Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
153
October 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease
  • Has measurable or nonmeasurable disease
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Has received prior anthracycline therapy
  • Has received prior taxane therapy
  • Patients with HER2-positive disease must have progressed on or following trastuzumab
  • Patients with hormone receptor-positive disease must have progressed on or following hormone therapy
  • Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
  • Has completed any prior radiotherapy ≥ 4 weeks prior to randomization
  • Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization
  • Has AEs that have resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy
  • Has adequate hematologic, coagulation, hepatic and renal function
  • Does not have:

    • cirrhosis at a level of Child-Pugh B (or worse) or
    • cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
  • Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
  • Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication

Exclusion Criteria:

  • Has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 years
  • Has a known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80
  • Has a known sensitivity to 5-FU
  • Has a known dihydropyrimidine dehydrogenase deficiency
  • Has received prior capecitabine treatment for advanced breast cancer
  • Has received investigational therapy within 2 weeks prior to randomization
  • Has received bevacizumab within 4 weeks prior to randomization
  • Has received more than 1 prior antiangiogenic agent for breast cancer
  • Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or IMC-18F1, or other agents that specifically target VEGF
  • Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
  • Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
  • Has experienced a Grade ≥ 3 bleeding event within 3 months prior to randomization
  • Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant
  • Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator
  • Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization
  • Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
  • Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
  • Has received a prior allogeneic organ or tissue transplantation
  • Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
  • Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization
  • Has known HIV or AIDS infection
  • Has an elective or planned major surgery to be performed during the course of the trial
  • Patient is pregnant or lactating
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01234402
13944, CP20-0903, I4Y-IE-JCDD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP