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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597036
• Other study ID #: 15580
• Secondary ID: I7W-MC-JQBA2015-
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2015
• Est. completion date: May 24, 2020

Study information

• Verified date: October 15, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 24, 2020
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• LY3127804
Administered IV
• Ramucirumab
Administered IV
• Paclitaxel
Administered IV

Locations

Country	Name	City	State
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.	Brussel
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.	Villejuif
Spain	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
United States	SMO Sarah Cannon Research Inst.	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)		Baseline through Cycle 1 (28 Day Cycle)
Secondary	Maximum Total Dose (MTD) of LY3127804 Monotherapy and in Combination with Ramuricumab +/- Paclitaxel		Baseline through Cycle 1 (28 Day Cycle)
Secondary	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3127804		Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
Secondary	Pharmacokinetics: AUC of Ramucirumab in Combination with LY3127804 +/- Paclitaxel		Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 4 Months)
Secondary	Number of Participants with Anti-LY3127804 Antibodies		Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
Secondary	Number of Participants with Anti-Ramucirumab Antibodies		Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Estimated up to 5 Months)
Secondary	Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]		Baseline through Measured Progressive Disease or Death (Estimated up to 4 Months)
Secondary	Progression Free Survival (PFS)		Baseline to Measured Progressive Disease or Death (Estimated up to 4 Months)

External Links

•   Click here for more information about this study:A Study of LY3127804 with Ramucirumab in Participants with Advanced Solid Tumors