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

A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors

Sponsors

Lead Sponsor: Eli Lilly and Company

Source 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.

Overall Status Not yet recruiting
Start Date November 18, 2020
Completion Date September 1, 2022
Primary Completion Date July 1, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)
PK: Maximum Concentration (Cmax) of Ramucirumab Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)
PK: Serum Trough Concentration (Ctrough) of Ramucirumab Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)
Secondary Outcome
Measure Time Frame
Percentage of Participants with Anti-Ramucirumab Antibodies Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)
Percentage of Participants with Injection Site Reactions (ISRs) Cycle 1 Day 1 through Cycle 3 Day 21 (21 Day Cycles)
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ramucirumab

Description: Administered SC

Arm Group Label: Ramucirumab

Other Name: LY3009806

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Overall Contact

Last Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
Facility: Contact: Investigator:
Highlands Oncology Group | Fayetteville, Arkansas, 72703, United States 479-587-1700 Joseph T Beck Principal Investigator
Hematology Oncology Associates of Treasure Coast | Port Saint Lucie, Florida, 34952, United States 772-408-5159 Paul M Swanson Principal Investigator
Oncology Hematology West | Omaha, Nebraska, 68130, United States 402-691-6971 Ralph J Hauke Principal Investigator
Tennessee Oncology PLLC | Nashville, Tennessee, 37203, United States 615-721-0930 James Michael Pauff Principal Investigator
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Ramucirumab

Type: Experimental

Description: Ramucirumab given subcutaneously (SC).

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov