Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04557384
Recruitment Status : Terminated (Study terminated due to a business decision)
First Posted : September 21, 2020
Last Update Posted : September 8, 2021
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study in participants with advanced cancer is to learn more about the safety of ramucirumab when given by injection under the skin (subcutaneous injection). The study will also measure how much ramucirumab gets into the bloodstream and how long it takes the body to get rid of it.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Ramucirumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors
Actual Study Start Date : February 23, 2021
Actual Primary Completion Date : May 25, 2021
Actual Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arm Intervention/treatment
Experimental: Ramucirumab
Ramucirumab given subcutaneously (SC).
Drug: Ramucirumab
Administered SC
Other Name: LY3009806

Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab [ Time Frame: Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months) ]
    PK: AUC of Ramucirumab

  2. PK: Maximum Concentration (Cmax) of Ramucirumab [ Time Frame: Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months) ]
    PK: Cmax of Ramucirumab

  3. PK: Serum Trough Concentration (Ctrough) of Ramucirumab [ Time Frame: Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months) ]
    Ctrough of Ramucirumab

Secondary Outcome Measures :
  1. Percentage of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months) ]
    Percentage of Participants with Anti-Ramucirumab Antibodies

  2. Percentage of Participants with Injection Site Reactions (ISRs) [ Time Frame: Cycle 1 Day 1 through Cycle 3 Day 21 (21 Day Cycles) ]
    Percentage of Participants with ISRs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
  • In the judgment of the investigator, be an appropriate candidate for experimental therapy and:

    • For Cohort A only: Have exhausted all anticancer treatments with proven clinical benefit OR
    • For Cohorts B and C only: Must have one of the three conditions below:

      • Have exhausted all anti-cancer treatments with proven clinical benefit, OR
      • Have hepatocellular carcinoma or gastric cancer who have received prior treatment, and where IV ramucirumab monotherapy is clinically acceptable treatment after progression OR
      • Have a diagnosis for which IV ramucirumab in combination with additional anticancer therapy is clinically acceptable treatment
      • Additionally, it must be clinically acceptable to delay initiation of the combination partner for 3 weeks from the initiation of ramucirumab dosing.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Have discontinued all previous treatments for cancer with adequate wash-out period and recovered from the acute effects of therapy.
  • Have adequate hematologic, hepatic, and renal functions and electrolytes.
  • Males and females of child-bearing potential must agree to use highly effective contraceptive methods during study treatment and for at least 84 days/12 weeks following the last dose of study drug.

Exclusion Criteria:

  • Have uncontrolled hypertension defined as systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg despite standard medical management.
  • Have significant bleeding disorders or experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment.
  • Have hepatic impairment (such as severe liver cirrhosis Child-Pugh B [or worse], cirrhosis with a history of hepatic encephalopathy, clinically meaningful ascites requiring ongoing treatment with diuretics and/or paracentesis, or history of hepatorenal syndrome).
  • Have experienced any arterial thromboembolic events (ATEs), including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, ≤6 months prior to randomization.
  • The participant has clinically relevant congestive heart failure (CHF; New York Heart Association [NYHA] Grade ≥2) or symptomatic or poorly controlled cardiac arrhythmia.
  • Have symptomatic central nervous system (CNS) metastases. Screening is not required.
  • Have history of GI perforation and/or fistula within 6 months prior to enrollment.
  • Have an active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
  • Have a serious or non-healing wound, ulcer, or bone fracture within 4 weeks prior to enrollment.
  • Have received IV ramucirumab in the past.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04557384

Layout table for location information
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, Nebraska
Oncology Hematology West
Omaha, Nebraska, United States, 68130
United States, North Carolina
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan, 589 8511
Sponsors and Collaborators
Eli Lilly and Company
Layout table for investigator information
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
Additional Information:
Layout table for additonal information
Responsible Party: Eli Lilly and Company Identifier: NCT04557384    
Other Study ID Numbers: 17800
I4T-MC-JVDU ( Other Identifier: Eli Lilly and Company )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents