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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557384
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : February 23, 2021
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Study Start Date : March 2, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2022

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.


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

Inclusion Criteria:

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

    • Have exhausted all anticancer treatments with proven clinical benefit OR
    • For Cohorts B and C only: In addition to above participant population described in a.

      • 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT04557384


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Contact    479-587-1700      
Principal Investigator: Joseph T Beck         
United States, Nebraska
Oncology Hematology West
Omaha, Nebraska, United States, 68130
Contact    402-691-6971      
Principal Investigator: Ralph J Hauke         
United States, North Carolina
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Contact    980-442-2000      
Principal Investigator: Jimmy J Hwang         
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Contact    615-329-7274      
Principal Investigator: David R Spigel         
Japan
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan, 589 8511
Contact    81120023812      
Principal Investigator: Hidetoshi Hayashi         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov 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: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
safety
Additional relevant MeSH terms:
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Ramucirumab
Antineoplastic Agents