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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02597036
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: LY3127804 Drug: Ramucirumab Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : May 24, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arm Intervention/treatment
Experimental: Part A LY3127804
Dose escalation of LY3127804 given intravenously (IV) every 2 weeks (Q2W) for 28 day cycle.
Drug: LY3127804
Administered IV

Experimental: Part B LY3127804 + Ramucirumab Dose 1
Dose escalation of LY3127804 in combination with Ramucirumab given IV Q2W for 28 day cycle.
Drug: LY3127804
Administered IV

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • Cyramza
  • 1121B

Experimental: Part C LY3127804 + Ramucirumab Dose 2
LY3127804 in combination with Ramucirumab given IV Q2W for 28 day cycle.
Drug: LY3127804
Administered IV

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • Cyramza
  • 1121B

Experimental: Part D LY3127804 + Ramucirumab
LY3127804 and Ramucirumab given IV Q2W until participant qualifies for study discontinuation.
Drug: LY3127804
Administered IV

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • Cyramza
  • 1121B

Experimental: Part E LY3127804 + Ramucirumab + Paclitaxel
LY3127804 and Ramucirumab given IV Q2W and Paclitaxel given IV on day 1, 8, and 15 until participant qualifies for study discontinuation.
Drug: LY3127804
Administered IV

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • Cyramza
  • 1121B

Drug: Paclitaxel
Administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597036


Locations
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United States, Tennessee
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
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, Belgium, 1000
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, France, 94805
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, Spain, 08035
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02597036    
Other Study ID Numbers: 15580
I7W-MC-JQBA ( Other Identifier: Eli Lilly and Company )
2015-001204-64 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 15, 2020
Keywords provided by Eli Lilly and Company:
Advanced, Angiopoietin
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action