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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027284
• Other study ID #: 16330
• Secondary ID: I3O-JE-JSBG
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2017
• Est. completion date: March 17, 2020

Study information

• Verified date: May 15, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 17, 2020
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Cancer
• Biliary Tract Carcinoma
• Carcinoma
• Cholangiocarcinoma
• Gall Bladder Carcinoma
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Non-Hodgkin's Lymphoma
• Solid Tumor
• Urinary Bladder Neoplasms

Intervention

Drug:
• Merestinib
Administered orally
• Cisplatin
Administered IV
• Gemcitabine
Administered IV

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)	Number of participants with DLTs	Cycle 1 (Part A = 28 Days or Part B = 21 Days)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites	PK: Cmax of merestinib and its metabolites	Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)
Secondary	PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites	PK: AUC of merestinib and its metabolites	Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)
Secondary	Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response	ORR: Percentage of participants with a complete or partial response	Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)
Secondary	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	Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)