A Study of LY2940680 in Japanese Participants With Advanced Cancers

NCT ID: NCT01919398

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-06-28

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.

Conditions

Neoplasm Metastasis

Study Design

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

Study Groups

LY2940680

Cohort 1: 100 mg LY2940680 administered orally daily in 28-day cycles. Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles. Cohort 3: 400 mg LY2940680 administered orally daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Group Type: EXPERIMENTAL

LY2940680

Intervention Type: DRUG

Administered orally

Interventions

LY2940680

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease
• Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1
• Have adequate organ function
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy for at least 3 weeks (6 weeks for mitomycin-C or nitrosoureas, 2 weeks for palliative radiation therapy for bone metastasis) prior to study enrollment, and have recovered from the acute effects of any such therapy
• Males must agree to use medically approved barrier contraceptive precautions during the study and for 6 months following the last dose of study drug
• Females with child bearing potential must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug; have had a negative serum 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, the female must stop breastfeeding from the day of the first study drug administration until at least 6 months after the last administration
• Have an estimated life expectancy, in the judgment of the investigator, which will permit the participant to complete 2 cycles of treatment
• Are able to swallow tablets

Exclusion Criteria

• Have received treatment within 21 days of the study enrollment with any agent that has not received regulatory approval for any indication
• Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function and off steroids after cranial irradiation ending at least 14 days prior to enrollment, or after surgical resection performed at least 28 days prior to enrollment
• Have known current hematologic malignancies or acute or chronic leukemia
• Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis, potentially affecting the conduct of this study
• Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
• Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram (ECG)
• Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study
• Have received any medication that is a strong inhibitor of cytochrome P4503A4 (CYP3A4) within 7 days prior to receiving study drug

• 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

1-858-255-5959 Mon-Fri from 9 AM to 5 PM Pacific Time (PST)

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri from 9 AM to 5 PM Pacific Time (PST), or speak with your personal physician.

Shizuoka, , Japan

For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri from 9 AM to 5 PM Pacific Time (PST), or speak with your personal physician.

Tokyo, , Japan

Countries

Japan

Other Identifiers

I4J-MC-HHBH

Identifier Type: OTHER

Identifier Source: secondary_id

14895 TRANSFERRED

Identifier Type: -

Identifier Source: org_study_id