A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ramucirumab Ramucirumab given subcutaneously (SC). |
Drug: Ramucirumab
Administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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: AUC of Ramucirumab
- PK: Maximum Concentration (Cmax) of Ramucirumab [Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)]
PK: Cmax of Ramucirumab
- PK: Serum Trough Concentration (Ctrough) of Ramucirumab [Cycle 1 Day 1 through End of Treatment (Estimated up to 10 Months)]
Ctrough of Ramucirumab
Secondary Outcome Measures
- Percentage of Participants with Anti-Ramucirumab Antibodies [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) [Cycle 1 Day 1 through Cycle 3 Day 21 (21 Day Cycles)]
Percentage of Participants with ISRs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
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In the judgment of the investigator, be an appropriate candidate for experimental therapy and:
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For Cohort A only: Have exhausted all anticancer treatments with proven clinical benefit OR
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For Cohorts B and C only: Must have one of the three conditions below:
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Have exhausted all anti-cancer treatments with proven clinical benefit, OR
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Have hepatocellular carcinoma or gastric cancer who have received prior treatment, and where IV ramucirumab monotherapy is clinically acceptable treatment after progression OR
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Have a diagnosis for which IV ramucirumab in combination with additional anticancer therapy is clinically acceptable treatment
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Additionally, it must be clinically acceptable to delay initiation of the combination partner for 3 weeks from the initiation of ramucirumab dosing.
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Eastern Cooperative Oncology Group performance status score of 0 or 1.
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Have discontinued all previous treatments for cancer with adequate wash-out period and recovered from the acute effects of therapy.
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Have adequate hematologic, hepatic, and renal functions and electrolytes.
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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:
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Have uncontrolled hypertension defined as systolic blood pressure (BP) >150 mmHg or diastolic BP >90 mmHg despite standard medical management.
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Have significant bleeding disorders or experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment.
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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).
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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.
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The participant has clinically relevant congestive heart failure (CHF; New York Heart Association [NYHA] Grade ≥2) or symptomatic or poorly controlled cardiac arrhythmia.
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Have symptomatic central nervous system (CNS) metastases. Screening is not required.
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Have history of GI perforation and/or fistula within 6 months prior to enrollment.
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Have an active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
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Have a serious or non-healing wound, ulcer, or bone fracture within 4 weeks prior to enrollment.
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Have received IV ramucirumab in the past.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Highlands Oncology Group | Fayetteville | Arkansas | United States | 72703 |
| 2 | Oncology Hematology West | Omaha | Nebraska | United States | 68130 |
| 3 | Levine Cancer Institute- Carolinas Medical Center | Charlotte | North Carolina | United States | 28204 |
| 4 | Tennessee Oncology PLLC | Nashville | Tennessee | United States | 37203 |
| 5 | Kindai University Hospital | Osaka Sayama-shi | Osaka | Japan | 589 8511 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17800
- I4T-MC-JVDU