A Study of Merestinib (LY2801653) in Japanese Participants With Advanc

Japan – Not Yet Open.

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

https://clinicaltrials.gov/ct2/show/NCT03027284

Purpose
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.

Condition Intervention Phase
Advanced Cancer
Metastatic Cancer
Biliary Tract Carcinoma
Cholangiocarcinoma
Gall Bladder Carcinoma
Solid Tumor
Non-Hodgkin’s Lymphoma
Drug: Merestinib
Drug: Cisplatin
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride
Genetic and Rare Diseases Information Center resources: Lymphosarcoma Gallbladder Cancer
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
Number of Participants with Merestinib Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Part A = 28 Days or Part B = 21 Days) ]

Secondary Outcome Measures:
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites [ Time Frame: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles) ]
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites [ Time Frame: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles) ]
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months) ]
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months) ]

Estimated Enrollment: 18
Study Start Date: January 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Experimental: 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.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Experimental: Merestinib + Cisplatin + Gemcitabine (Part
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.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Drug: Cisplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Name: LY188011

Eligibility

Ages Eligible for Study: 20 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03027284

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03027284 History of Changes
Other Study ID Numbers: 16330 I3O-JE-JSBG
Study First Received: January 19, 2017
Last Updated: January 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No