A Study of Ramucirumab in Participants With Metastatic Renal Cell Carcinoma

NCT00515697 | Completed Phase 2 Results

• 3 other identifiers: 13921I4T-IE-JVBPCP12-0605
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (Objective Response Rate)

  The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)\*100.

  First dose to date of objective progressive disease or death due to any cause (up to 34 months)

Secondary Outcomes (7)

• Progression-Free Survival

  First dose to measured progressive disease or death due to any cause (up to 34 months)

• Percentage of Participants Showing Disease Control at Week 12

  Week 12 [Cycle 6 (1 cycle=14 days)]

• Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks

  Week 12 [Cycle 6 (1 cycle=14 days)]

• Median Duration of Overall Response

  Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)

• Minimum Concentration (Cmin) of Ramucirumab

  Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]

Study Arms (1)

Ramucirumab

EXPERIMENTAL

Intravenous infusion at 8 milligrams per kilogram (mg/kg) on day 1 of every 14-day cycle.

Biological: Ramucirumab

Interventions

Ramucirumab BIOLOGICAL

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.

Also known as: IMC-1121B, LY3009806

Ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has histologically or cytologically confirmed clear cell RCC
• The participant is ≥ 18 years of age
• The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 or Karnofsky Performance Status (KPS) ≥ 80%
• The participant has had a prior nephrectomy (as therapy for RCC)
• The participant has metastatic RCC
• The participant has a life expectancy of \> 3 months
• The participant has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
• The participant 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 participant with progression during a protracted treatment break is not eligible unless the participant has had progression or intolerance as defined above
• The participant 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)
• The participant has adequate hematological functions \[absolute neutrophil count (ANC) ≥ 1500 cells per milliliter (cells/mL), hemoglobin ≥ 9 grams per deciliter (g/dL) and platelets ≥ 100,000 cells/mL\]
• The participant has adequate hepatic function \[bilirubin within normal limits (WNL), aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases\]
• The participant has normal renal function or mild renal dysfunction \[creatinine ≤ 2.2 milligrams per deciliter (mg/dL)\]
• The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis \[(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate \< 1000 (milligrams) mg of protein in 24 hours to allow participation in the study\]
• The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.8 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN. Participants 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 (for example, tumor involving major vessels or known varices)
• The participant is able to provide informed written consent

You may not qualify if:

• The participant has received prior treatment with bevacizumab
• The participant has known brain or leptomeningeal metastases
• The participant has received \>2 prior cytotoxic chemotherapy regimens for RCC
• The participant has received antitumor therapy (biologic agents, major surgery, or investigational agent) within 28 days prior to enrollment on study. The participant has received radiation therapy within 14 days prior to enrollment on study. Participants 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
• The participant has received \> 1 prior bio-immunotherapy regimens (defined as either interleukin-2 or interferon alpha given as monotherapy, concurrently, or sequentially as planned)
• The participant has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years
• The participant has a nonhealing wound or ulcer
• The participant has a known alcohol or drug dependency
• The participant is pregnant or breastfeeding
• The participant 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
• The participant 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
• The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (11)

ImClone Investigational Site

San Francisco, California, 94115, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60637, United States

Location

ImClone Investigational Site

Metairie, Louisiana, 70006, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02115, United States

Location

ImClone Investigational Site

Flemington, New Jersey, 08822, United States

Location

ImClone Investigational Site

Buffalo, New York, 14263, United States

Location

ImClone Investigational Site

Cleveland, Ohio, 44195, United States

Location

ImClone Investigational Site

Drexel Hill, Pennsylvania, 19026, United States

Location

ImClone Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

ImClone Investigational Site

Arlington, Texas, 76012, United States

Location

ImClone Investigational Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-05

Locations

US (11)