Advanced Solid TumorPhase 1NCT04557384
A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
A Phase 1 study testing Ramucirumab in people with Advanced Solid Tumor, run by Eli Lilly and Company at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Ramucirumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 23 Feb 2021to 25 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, 28204
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Oncology Hematology West
Omaha, Nebraska, 68130
About this study
Official title: A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors
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
- Being tested
- Ramucirumab
- Keywords
- Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Also called LY3009806
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab
PK: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days.
Measured: 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.
Measured: 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.
Measured: C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose
Secondary outcomes (2)
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).
Measured: C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start23 Feb 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Why it stopped: Study terminated due to inadequate PK profile associated with the subcutaneous formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557384
- Sponsor's protocol ID
- 17800
- Other IDs
- I4T-MC-JVDU
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2020
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04557384
- Acronym / sponsor ID
- 17800
- Conditions
- Advanced Solid Tumor
- Keywords
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to inadequate PK profile associated with the subcutaneous formulation.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab | Experimental | Drug: RamucirumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamucirumabAlso: LY3009806Administered SC | Drug | Ramucirumab |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab
Time frame: 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: AUC of Ramucirumab over the dosing interval was evaluated. Cycle = 21 days.
PK: Maximum Concentration (Cmax) of Ramucirumab
Time frame: 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: Cmax of Ramucirumab was evaluated.
PK: Serum Trough Concentration (Ctrough) of Ramucirumab
Time frame: C1D8: predose; C1D15: predose; C2D1: predose; C2D8: predose; C3D1: predose
Ctrough of Ramucirumab was evaluated.
2 secondary outcomes
Percentage of Participants With Anti-Ramucirumab Antibodies
Time frame: C1D1: predose; C1D15: predose; C2D8: predose; C4D1: predose
Number of Participants With Injection Site Reactions (ISRs)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ramucirumab in people with Advanced Solid Tumor, run by Eli Lilly and Company at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Ramucirumab (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.