Clinical Trials /

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

NCT04557384

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
  • Official Title: A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17800
  • SECONDARY ID: I4T-MC-JVDU
  • NCT ID: NCT04557384

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
RamucirumabLY3009806Ramucirumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RamucirumabExperimentalRamucirumab given subcutaneously (SC).
  • Ramucirumab

Eligibility 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:

               1. Have exhausted all anticancer treatments with proven clinical benefit OR

               2. Have Hepatocellular carcinoma or Gastric Cancer who have received prior
                  treatment, and where IV ramucirumab monotherapy is clinically acceptable
                  treatment after progression OR

               3. For Cohorts B and C only: 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 5 months 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:PK: AUC of Ramucirumab

Secondary Outcome Measures

Measure:Percentage of Participants with Anti-Ramucirumab Antibodies
Time Frame:Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)
Safety Issue:
Description:Percentage of Participants with Anti-Ramucirumab Antibodies
Measure:Percentage of Participants with Injection Site Reactions (ISRs)
Time Frame:Cycle 1 Day 1 through Cycle 3 Day 21 (21 Day Cycles)
Safety Issue:
Description:Percentage of Participants with ISRs

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • safety

Last Updated

September 21, 2020