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A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents

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: NCT02745769
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Colorectal Cancer Mantle Cell Lymphoma Drug: Ramucirumab Drug: Merestinib Drug: Abemaciclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1a/1b Study of Ramucirumab in Combination With Other Targeted Agents in Advanced Cancers
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramucirumab + Merestinib
Ramucirumab intravenously (IV) on day 1 and day 15 in combination with merestinib orally once a day over a 28 day cycle. Participants receiving benefit may continue until disease progression.
Drug: Ramucirumab
Administered IV
Other Name: LY3009806

Drug: Merestinib
Administered orally
Other Name: LY2801653

Experimental: Ramucirumab + Abemaciclib

Ramucirumab IV on day 1 and day 15 in combination with abemaciclib orally twice a day over a 28 day cycle. Participants receiving benefit may continue until disease progression.

On June 21st 2017 the Ramucirumab + Abemaciclib arm was cancelled with no participants enrolled.

Drug: Ramucirumab
Administered IV
Other Name: LY3009806

Drug: Abemaciclib
Administered orally
Other Name: LY2835219




Primary Outcome Measures :
  1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab, Merestinib and Abemaciclib [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 6 Day 1 (28 day cycles) ]
  2. Proportion 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 24 months) ]
  3. Progression Free Survival (PFS) [ Time Frame: Baseline through Measured Progressive Disease or Death (Estimated up to 24 months) ]


Information from the National Library of Medicine

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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:

  • Study Arm 1:

    • histopathologically confirmed advanced or metastatic colorectal cancer, excluding primary tumors of appendiceal origin
    • have at least 1 measurable lesion assessable by radiological imaging. Tumor lesions located in a previously irradiated area are considered measureable if progression has been demonstrated in such lesions
    • have received prior second-line treatment with oxaliplatin and/or irinotecan, and no other licensed/standard-of-care therapies are available. If the participant has RAS wild type colorectal cancer, he or she also must have received prior treatment with an epidermal growth factor receptor monoclonal antibody
  • Study Arm 2

    • pathologically confirmed mantle cell lymphoma (MCL), with (a) measurable nodal disease on positron emission tomography computed tomography (PET-CT) per Lugano classification. Prior to enrollment, pathology must be reviewed and confirmed at the investigational site where the participant is entered
    • have MCL that relapsed after or is refractory to (a) first-line combination chemotherapy with or without stem cell transplant and (b) at least 1 other locally available therapy
    • provide a newly obtained tumor tissue sample. Tumor tissue biopsies may be taken by surgical resection, core needle biopsy, or fine needle biopsy
  • All Study Arms:

    • have not received previous systemic therapy (including investigational agents) targeting programmed cell death protein 1 (PD-1)/ PD-1 ligand (PDL 1) or PD-1/PDL-2 signaling pathways. Prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-CD137 antibody or anticytotoxic T-lymphocyte-associated antigen-4 antibody, is not permitted
    • have adequate organ function
    • are, in the judgment of the investigator, appropriate candidates for experimental therapy after available standard therapies have failed to provide clinical benefit
    • have discontinued all previous treatments for cancer and recovered from the acute effects of therapy, other than less than or equal to Grade 2 neuropathy or nonserious and nonlife-threatening toxicities such as alopecia, altered taste, and nail changes
    • have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
    • men and women must agree to the use an effective method of contraception during the study and for at least 3 months post last dose of study drug administration. Women of child-bearing potential must have negative serum and urine pregnancy tests at screening and during each treatment cycle, respectively

Exclusion Criteria:

  • Study Arm 1

    • have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection; inadequate biliary drainage with evidence of unresolved biliary obstruction
  • Study Arm 2

    • have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection, including chronic viral hepatitis
  • All Arms:

    • have prior or concurrent malignancies, inclusive of hematologic, primary brain tumor, sarcoma, and other solid tumors, unless in complete remission with no therapy for a minimum of 5 years
    • have active gastrointestinal (GI) disease characterized by inflammatory bowel disease, malabsorption syndrome, or frequent Grade 2 or more diarrhea
    • are pregnant or breastfeeding
    • have previously documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
    • have experienced any of the following: a major surgical procedure, significant traumatic injury, non-healing wound, peptic ulcer, or bone fracture less than or equal to 28 days prior to enrollment, or placement of a subcutaneous venous access device less than or equal to 7 days prior to the first dose of study treatment unless the procedure is of low risk of bleeding in the judgment of the investigator
    • have an elective or a planned major surgery during the course of the trial
    • have a known allergy or hypersensitivity reaction to any of the treatment components
    • have uncontrolled hypertension
    • have experienced any arterial thromboembolic event within 6 months prior to enrollment
    • have experienced any Grade 3 or 4 venous thromboembolic event that is considered by the investigator to be life threatening or that is symptomatic and not adequately treated by anticoagulation therapy, within 6 months prior to enrollment
    • have a history of GI perforation and/or fistulae within 6 months prior to enrollment
    • have experienced any bleeding episode considered life-threatening, or any Grade 3 or 4 GI/variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention
    • have congestive heart failure or poorly controlled cardiac arrhythmia per New York Heart Association Class II-IV heart disease

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): NCT02745769


Locations
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United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35249
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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.
Lyon, France, 69373
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.
Marseille, France, 13385
United Kingdom
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.
London, United Kingdom, SE1 9RT
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: NCT02745769     History of Changes
Other Study ID Numbers: 16165
I4T-MC-JVDK ( Other Identifier: Eli Lilly and Company )
2015-004381-28 ( EudraCT Number )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 1, 2019
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ramucirumab
Antineoplastic Agents