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

NCT04557384 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 17800I4T-MC-JVDU
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 5

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.

Conditions

Advanced Solid Tumor

Keywords

Safety

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab

  PK: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days.

  Cycle (C) 1 Day (D) 1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose

• PK: Maximum Concentration (Cmax) of Ramucirumab

  PK: Cmax of Ramucirumab was evaluated.

  C1D1:Predose; C1D2:24 hours (h) postdose;C1D4:48-96 h postdose;C1D8:predose;C1D15:predose;C1D18:48-96 h postdose;C2D1:predose;C2D8:predose;C2D11:48-96h postdose;C3D1:predose

• PK: Serum Trough Concentration (Ctrough) of Ramucirumab

  Ctrough of Ramucirumab was evaluated.

  C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose

Secondary Outcomes (2)

• Percentage of Participants With Anti-Ramucirumab Antibodies

  C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose

• Number of Participants With Injection Site Reactions (ISRs)

  Cycle 1, Cycle 2, Cycle 3: D1, D8, D15, D22: 5-15 min, 60 min post injection; C1D2: 24 hours (h) post injection; C1D4 (± 1 day)

Study Arms (1)

Ramucirumab

EXPERIMENTAL

Participants received starting dose of 700 milligram (mg) ramucirumab loading dose (LD) subcutaneously (SC) followed, a week later, by 350 mg ramucirumab maintenance dose (MD) administered SC once a week.

Drug: Ramucirumab

Interventions

Ramucirumab DRUG

Administered SC

Also known as: LY3009806

Ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Oncology Hematology West

Omaha, Nebraska, 68130, United States

Location

Levine Cancer Institute- Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Kindai University Hospital

Osaka Sayama-shi, Osaka, 589 8511, Japan

Location

Related Links

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

MeSH Terms

Interventions

Ramucirumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Study was terminated due to low likelihood of achieving a relevant therapeutic exposure.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 21, 2020
• Study Start: February 23, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); JP (1)