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. |
ClinicalTrials.gov Identifier: NCT04557384 |
Recruitment Status :
Terminated
(Study terminated due to a business decision)
First Posted : September 21, 2020
Last Update Posted : September 8, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor | Drug: Ramucirumab | Phase 1 |
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 |

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

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.
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.

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
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 | |
Japan | |
Kindai University Hospital | |
Osaka Sayama-shi, Osaka, Japan, 589 8511 |
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 |
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: | September 8, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Safety |
Ramucirumab Antineoplastic Agents |