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Advanced CancerPhase 1NCT02745769

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

A Phase 1 study testing Ramucirumab, Merestinib and Abemaciclib in people with Advanced Cancer and Colorectal Cancer, run by Eli Lilly and Company at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramucirumab, Merestinib and Abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
5 sitesin 3 countries
Study dates
21 Oct 2016to 22 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States2 sites

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35249

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

France2 sites

  • 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, 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, 13385

Other trials in France

United Kingdom1 site

  • 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, SE1 9RT

Other trials in United Kingdom

About this study

Official title: An Open-Label, Phase 1a/1b Study of Ramucirumab in Combination With Other Targeted Agents in Advanced Cancers

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

Being tested
Ramucirumab, Merestinib, Abemaciclib
Medical subject headings
Colorectal Neoplasms, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabDrug

    Also called LY3009806

    Administered IV

  • MerestinibDrug

    Also called LY2801653

    Administered orally

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally

Study groups in NCT02745769
Study groupRoleWhat they receive
Ramucirumab + MerestinibExperimentalRamucirumab 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.
Receives: Drug: Ramucirumab; Drug: Merestinib
Ramucirumab + AbemaciclibExperimentalRamucirumab 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.
Receives: Drug: Ramucirumab; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1 (28 days)

Secondary outcomes (3)

  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab, Merestinib and Abemaciclib

    Measured: 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)]

    Measured: Baseline through Measured Progressive Disease or Death (Estimated up to 24 months)

  3. Progression Free Survival (PFS)

    Measured: Baseline through Measured Progressive Disease or Death (Estimated up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study start21 Oct 2016
  3. Primary completion5 Nov 2018
  4. Study completion22 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02745769
Sponsor's protocol ID
16165
Other IDs
I4T-MC-JVDK, 2015-004381-28, 2015
Status last verified
1 Mar 2019
First submitted
18 Apr 2016
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • Saleh M, Cassier PA, Eberst L, Naik G, Morris VK, Pant S, Terret C, Gao L, Long A, Mao H, McNeely S, Wagner EK, Carlesi RM, Fu S. Phase I Study of Ramucirumab Plus Merestinib in Previously Treated Metastatic Colorectal Cancer: Safety, Preliminary Efficacy, and Pharmacokinetic Findings. Oncologist. 2020 Nov;25(11):e1628-e1639. doi: 10.1634/theoncologist.2020-0520. Epub 2020 Jul 17.

    PubMed 32537847

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab, Merestinib and Abemaciclib in people with Advanced Cancer and Colorectal Cancer, run by Eli Lilly and Company at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02745769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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