A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors
NCT ID: NCT02597036
Last Updated: 2025-10-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
62 participants
INTERVENTIONAL
2015-11-06
2020-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part C LY3127804 + 12 mg/kg Ramucirumab
Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
LY3127804
Administered IV
Ramucirumab
Administered IV
Part D LY3127804 + Ramucirumab - Not Enrolled
Participants were to receive LY3127804 and Ramucirumab IV Q2W until participant qualifies for study discontinuation.
Part D and E were not enrolled based on the primary and secondary outcomes/ results of Part A-C.
LY3127804
Administered IV
Ramucirumab
Administered IV
Part E LY3127804 + Ramucirumab + Paclitaxel - Not Enrolled
Participants were to receive LY3127804 and Ramucirumab IV Q2W and Paclitaxel IV on day 1, 8, and 15 until participant qualifies for study discontinuation.
Part D and E were not enrolled based on the primary and secondary outcomes/ results of Part A-C.
LY3127804
Administered IV
Ramucirumab
Administered IV
Paclitaxel
Administered IV
Part A LY3127804
Participants received escalating doses of 4 milligram per kilogram (mg/kg), 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as intravenous (IV) infusion on days 1 and 15 of a 28-day cycle.
LY3127804
Administered IV
Part B LY3127804 + 8 mg/kg Ramucirumab
Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
LY3127804
Administered IV
Ramucirumab
Administered IV
Interventions
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LY3127804
Administered IV
Ramucirumab
Administered IV
Paclitaxel
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST ) version 1.1.
* Have adequate organ function.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have discontinued previous treatments for cancer for at least 28 days or 5 half-lives prior to study enrolment.
Exclusion Criteria
* Have received treatment with a drug predominantly targeting Ang2 activity.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have current hematologic malignancies.
* Have an active fungal, bacterial, and/or known viral infection.
* Have a corrected QT interval using Fridericia's correction (QTcF) of \>470 msec on screening electrocardiogram (ECG) at several consecutive days of assessment.
* Have a known sensitivity to mAbs or other therapeutic proteins.
* Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
* Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 3 months prior to receiving treatment.
* Receive anticoagulation therapy at therapeutic dose.
* Have experienced any arterial or venothrombotic or thromboembolic events within 6 months prior to study treatment.
* Have liver cirrhosis with a Child-Pugh class B or worse or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
* The participant is pregnant prior to randomization or breastfeeding.
* The participant has sensory peripheral neuropathy ≥ Grade 2 (Part E only).
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussels, , Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Villejuif, , France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, , Spain
Countries
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References
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Martin-Liberal J, Hollebecque A, Aftimos P, Jungels C, Martin-Romano P, Rodon J, Kremer JD, Zhang W, Bendell J. First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. Br J Cancer. 2020 Oct;123(8):1235-1243. doi: 10.1038/s41416-020-1011-7. Epub 2020 Aug 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3127804 with Ramucirumab in Participants with Advanced Solid Tumors
Other Identifiers
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I7W-MC-JQBA
Identifier Type: OTHER
Identifier Source: secondary_id
2015-001204-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15580
Identifier Type: -
Identifier Source: org_study_id
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