A Phase 1 Study of LY3023414 in Japanese Patients with Advanced Malignancies

Phase 1

• Conditions: Advanced malignancy

• Registration Number: JPRN-jRCT2080222989
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate.
-Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
-Have adequate organ and coagulation function.
-Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
-Are able to swallow capsules.
-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 more than 7 days before the first dose of study drug.
-A breastfeeding woman must also 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

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified