A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:November 6, 2015
End Date:June 14, 2019

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A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3127804
given as monotherapy and in combination with Ramucirumab for participants with advanced or
metastatic solid tumors. The study will also include a safety exploration for the combination
of LY3127804 plus ramucirumab and paclitaxel


Inclusion Criteria:

- Have a diagnosis of cancer that is advanced and/or metastatic.

- 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 serious preexisting medical conditions.

- 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).
We found this trial at
3
sites
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, Tennessee 37203
Principal Investigator: Sarah Cannon Research Institute SCRI
Phone: 615-239-7615
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