AzTrials
AzTrials

Advanced CancerPhase 1NCT03027284

A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer

A Phase 1 study testing Merestinib, Cisplatin and Gemcitabine in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 2 sites in Japan.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Merestinib, Cisplatin and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesJapan
Study dates
3 Feb 2017to 17 Mar 2020
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma).
  • Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease.
  • Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria.
  • Part B: Measurable disease as defined by RECIST v1.1.
  • Adequate organ function including hematologic, hepatic and renal.
  • Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1.
Show all 11Show fewer
  • Are able to swallow tablets.
  • For participants in Part B, a tumor tissue sample is mandatory for biomarker analysis.
  • Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
  • Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
  • A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.

Who cannot join

  • Have serious pre-existing medical conditions.
  • Have a chronic underlying infection.
  • Have symptomatic central nervous system malignancy or metastasis.
  • Have an active fungal, bacterial, and/or known viral infection.
  • Part B: Have mixed hepatocellular biliary tract carcinoma histology.
  • Have liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant.
Show all 10Show fewer
  • Have a history of congestive heart failure with New York Heart Association (NYHA) class greater than 2, unstable angina, or have recent history of myocardial infarction, transient ischemic attacks, stroke, or arterial or venous vascular disease.
  • Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.
  • Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.
  • Have any evidence of clinically active interstitial lung disease (ILD).

Trial locations and contacts

2 sites in 1 country.

Japan2 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

    Chiba, 277 8577

  • 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

    Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic Cancer

The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.

Being tested
Merestinib, Cisplatin, Gemcitabine
Keywords
Neoplasm
Medical subject headings
Neoplasm Metastasis, Cholangiocarcinoma, Gallbladder Neoplasms, Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

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

  • MerestinibDrug

    Also called LY2801653

    Administered orally

  • CisplatinDrug

    Administered IV

  • GemcitabineDrug

    Also called LY188011

    Administered IV

Study groups in NCT03027284
Study groupRoleWhat they receive
Merestinib (Part A Dose Level 1)ExperimentalMerestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Receives: Drug: Merestinib
Merestinib (Part A Dose Level 2)ExperimentalMerestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Receives: Drug: Merestinib
Merestinib + Cisplatin + Gemcitabine (Part B)ExperimentalMerestinib administered orally with cisplatin and gemcitabine administered intravenously (IV). Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met, but Cisplatin and gemcitabine treatment will be limited to a maximum of 8 cycles.
Receives: Drug: Merestinib; Drug: Cisplatin; Drug: Gemcitabine

What is being measured

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

  1. Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)

    Number of participants with DLTs

    Measured: Cycle 1 (Part A = 28 Days or Part B = 21 Days)

Secondary outcomes (4)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites

    PK: Cmax of merestinib and its metabolites

    Measured: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)

  2. PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites

    PK: AUC of merestinib and its metabolites

    Measured: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)

  3. Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response

    ORR: Percentage of participants with a complete or partial response

    Measured: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)

  4. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, and Stable Disease

    DCR: Percentage of participants with a best overall response of complete response, partial response, and stable disease

    Measured: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)

Timeline

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

  1. First posted23 Jan 2017 (estimated)
  2. Study start3 Feb 2017
  3. Primary completion20 Jun 2019
  4. Study completion17 Mar 2020

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
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03027284
Sponsor's protocol ID
16330
Other IDs
I3O-JE-JSBG
Status last verified
15 May 2020
First submitted
19 Jan 2017
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Doi T, Yamamoto N, Naito Y, Kuboki Y, Koyama T, Piao Y, Tsujimoto N, Asou H, Inoue K, Kondo S. Merestinib monotherapy or in combination for japanese patients with advanced and/or metastatic cancer: A phase 1 study. Cancer Med. 2021 Oct;10(19):6579-6589. doi: 10.1002/cam4.4110. Epub 2021 Sep 9.

    PubMed 34499416

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Merestinib, Cisplatin and Gemcitabine in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 2 sites in Japan.

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 11 inclusion and 10 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 with Merestinib Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (Part A = 28 Days or Part B = 21 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 NCT03027284, 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 19 May 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in