A Study of LY2584702 in Solid Tumors

NCT ID: NCT01241461

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-11-30

Brief Summary

The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.

Conditions

Cancer

Study Design

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

Study Groups

LY2584702

Group Type: EXPERIMENTAL

LY2584702

Intervention Type: DRUG

Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.

Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.

Interventions

LY2584702

Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.

Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
• Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
• Have adequate organ function including:

• Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/liter (L), platelets greater than or equal to 100 x 10^9/L, and hemoglobin greater than or equal to 9 gram/deciliter (g/dL) (transfusions are not allowed prior to enrollment within 2 weeks).
• Renal: Serum creatinine less than or equal to 1.5 times ULN.
• Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
• Have an estimated life expectancy of 12 weeks or greater
• Are able to swallow capsules

Exclusion Criteria

• Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
• Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study.
• Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required).
• Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis is not required.
• Have hematologic malignancies, or lymphoma.

• 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

Countries

Japan

Other Identifiers

I3G-JE-JGCC

Identifier Type: OTHER

Identifier Source: secondary_id

13871

Identifier Type: -

Identifier Source: org_study_id