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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04557384
• Other study ID #: 17800
• Secondary ID: I4T-MC-JVDU
• Status: Terminated
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: May 25, 2021

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• Ramucirumab
Administered SC

Locations

Country	Name	City	State
Japan	Kindai University Hospital	Osaka Sayama-shi	Osaka
United States	Levine Cancer Institute- Carolinas Medical Center	Charlotte	North Carolina
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Oncology Hematology West	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	PK: Serum Trough Concentration (Ctrough) of Ramucirumab	Ctrough of Ramucirumab was evaluated.	C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose
Secondary	Percentage of Participants With Anti-Ramucirumab Antibodies	Percentage of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted).	C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose
Secondary	Number of Participants With Injection Site Reactions (ISRs)	The number of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.	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)

External Links

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