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

NCT ID: NCT03027284

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2020-03-17

Brief 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.

Conditions

Advanced Cancer; Metastatic Cancer; Biliary Tract Carcinoma; Cholangiocarcinoma; Gall Bladder Carcinoma; Solid Tumor; Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Merestinib (Part A Dose Level 1)

Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.

Group Type: EXPERIMENTAL

Merestinib

Intervention Type: DRUG

Administered orally

Merestinib (Part A Dose Level 2)

Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.

Group Type: EXPERIMENTAL

Merestinib

Intervention Type: DRUG

Administered orally

Merestinib + Cisplatin + Gemcitabine (Part B)

Merestinib 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.

Group Type: EXPERIMENTAL

Merestinib

Intervention Type: DRUG

Administered orally

Cisplatin

Intervention Type: DRUG

Administered IV

Gemcitabine

Intervention Type: DRUG

Administered IV

Interventions

Merestinib

Administered orally

Intervention Type: DRUG

Cisplatin

Administered IV

Intervention Type: DRUG

Gemcitabine

Administered IV

Intervention Type: DRUG

Other Intervention Names

LY2801653; LY188011

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, , Japan

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, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 34499416 (View on PubMed)

Other Identifiers

I3O-JE-JSBG

Identifier Type: OTHER

Identifier Source: secondary_id

16330

Identifier Type: -

Identifier Source: org_study_id