A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies

Phase 1

• Conditions: Solid Tumors, Lymphoma

• Registration Number: JPRN-jRCT2080221810
• 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: 2012-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Part A Have histological or cytological evidence of malignancies (solid tumor or lymphoma) that are advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have been used.
Part B1 Have histological or cytological diagnosis of advanced NSCLC, stage IV. Patients must be eligible for erlotinib therapy.
Part B2 Have histological or cytological diagnosis of advanced NSCLC, stage IV. Patients must be eligible for gefinitib therapy.
- Have adequate hematologic, hepatic and renal function.
- Have a performance status of equal to or less than 2.
- 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 enrollment, whichever is shorter, and recovered from the acute effects of therapy
- Have an estimated life expectancy, that will permit the participant to complete 8 weeks of treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified