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

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ClinicalTrials.gov Identifier: NCT04557384
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 16, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date March 25, 2021
Actual Study Start Date  ICMJE February 23, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
Official Title  ICMJE A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: Ramucirumab
Administered SC
Other Name: LY3009806
Study Arms  ICMJE Experimental: Ramucirumab
Ramucirumab given subcutaneously (SC).
Intervention: Drug: Ramucirumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
24
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04557384
Other Study ID Numbers  ICMJE 17800
I4T-MC-JVDU ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 15, 2021

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