A Study of Ramucirumab in Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00515697
First received: August 13, 2007
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether ramucirumab is effective treatment in patients with metastatic renal cell carcinoma who have developed progressive disease or become intolerant to tyrosine kinase inhibitor therapy.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Biological: Ramucirumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Single Arm Study of IMC-1121B in Patients With Metastatic Renal Cell Carcinoma With Disease Progression on or Intolerance to Tyrosine Kinase Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants with Objective Response(Objective Response Rate) [ Time Frame: 40 months ] [ Designated as safety issue: No ]
    The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR).


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 40 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is measured from the date of first dose to the first documented date of disease progression or death from any cause.

  • Percentage of Participants Showing Disease Control at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participants who are alive and have not experienced disease progression are considered to have disease control at 12 weeks.

  • Percentage of Participants with Objective Response (Objective Response Rate) at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12.

  • Median Duration of Overall Response [ Time Frame: 40 months ] [ Designated as safety issue: No ]
    Duration of response is the interval from date of initial documented response (complete response or partial response) to the first documented date of disease progression, initiation of other/additional antitumor therapy is first reported, or death.

  • Minimum concentration (Cmin) of ramucirumab [ Time Frame: Week 32 (cycle 16) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of ramucirumab [ Time Frame: Week 32 (cycle 16) ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: November 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab
Intravenous infusion at 8 mg/kg on day 1 of every 14-day cycle.
Biological: Ramucirumab
Ramucirumab is an injectable solution administered as an intravenous infusion over 1 hour at a dose of 8 mg/kg day 1 of every 14-day cycle.
Other Name: 1121B

Detailed Description:

The Primary objective is to determine the best objective response rate (ORR) of ramucirumab when administered to patients with metastatic renal cell carcinoma (RCC) whose disease has progressed during therapy with a tyrosine kinase inhibitor ({TKI}, sunitinib and/or sorafenib) or who have developed intolerance to these agents.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. The patient has histologically or cytologically confirmed clear cell RCC
  2. The patient is ≥ 18 years of age
  3. The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 or Karnofsky Performance Status (KPS) ≥ 80%
  4. The patient has had a prior nephrectomy (as therapy for RCC)
  5. The patient has metastatic RCC
  6. The patient has a life expectancy of > 3 months
  7. The patient has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
  8. The patient has received prior therapy with a TKI (sunitinib and/or sorafenib) with either disease progression on TKI therapy (progression within 60 days of the last dose of TKI) or intolerance to TKI (unable to continue therapy because of side-effects). A patient with progression during a protracted treatment break is not eligible unless the patient has had progression or intolerance as defined above
  9. The patient has resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE)
  10. The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥ 1500 cells/mL, hemoglobin ≥ 9 g/dL and platelets ≥ 100,000 cells/mL)
  11. The patient has adequate hepatic function (bilirubin within normal limits [WNL], aspartate transaminase [AST] and/or alanine transaminase [ALT] ≤ 2.5 times the upper limit of normal [ULN], or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases)
  12. The patient has normal renal function or mild renal dysfunction (creatinine ≤ 2.2 mg/dL)
  13. The patient's urinary protein ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study)
  14. The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.8 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices)
  15. The patient is able to provide informed written consent
  16. The patient, if sexually active, is postmenopausal (last menstrual period > 2 years prior to study), surgically sterile, or is using effective method of contraception in the opinion of the investigator
  17. The patient, if female, must have a negative serum pregnancy test upon entry into this study
  18. The patient has a normal thyroid stimulating hormone (TSH) value. Patients with an abnormal TSH may be eligible provided they meet all other eligibility criteria and have ECOG performance status 0-1. Patients with an abnormal TSH value require a full thyroid evaluation prior to enrollment. Endocrinology consultation may be performed at the discretion of the investigator
  19. The patient has serum calcium within normal limits

Exclusion Criteria

  1. The patient has received prior treatment with bevacizumab
  2. The patient has known brain or leptomeningeal metastases
  3. The patient has received >2 prior cytotoxic chemotherapy regimens for RCC
  4. The patient has received antitumor therapy (biologic agents, major surgery, or investigational agent) within 28 days prior to enrollment on study. The patient has received radiation therapy within 14 days prior to enrollment on study. Patients with metastasis in weight bearing bones at high risk for pathologic fracture may participate provided that appropriate surgical intervention and/or radiation therapy is undertaken and completed at least 28 days prior to enrollment
  5. The patient has received > 1 prior bioimmunotherapy regimens (defined as either interleukin-2 or interferon alpha given as monotherapy, concurrently, or sequentially as planned)
  6. The patient has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years
  7. The patient has a nonhealing wound or ulcer
  8. The patient has a known alcohol or drug dependency
  9. The patient is pregnant or breastfeeding
  10. The patient has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results
  11. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator
  12. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515697

Locations
United States, California
ImClone Investigational Site
San Francisco, California, United States, 94115
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60637
United States, Louisiana
ImClone Investigational Site
Metairie, Louisiana, United States, 70006
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02115
United States, New Jersey
ImClone Investigational Site
Flemington, New Jersey, United States, 08822
United States, New York
ImClone Investigational Site
Buffalo, New York, United States, 14263
United States, Ohio
ImClone Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
ImClone Investigational Site
Drexel Hill, Pennsylvania, United States, 19026
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
ImClone Investigational Site
Arlington, Texas, United States, 76012
United States, Washington
ImClone Investigational Site
Seattle, Washington, United States, 98109
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: NCT00515697     History of Changes
Other Study ID Numbers: 13921, 14T-IE-JVBP, CP12-0605
Study First Received: August 13, 2007
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014