A Phase 1 Dose-Escalation Study of LY2603618 in Combination with Gemcitabine in Japanese Patients with Solid Tumors

Phase 1

• Conditions: Solid Tumors

• Registration Number: JPRN-jRCT2080221454
• 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: 2011-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Have histological or cytological or imaging evidence of a diagnosis of cancer that is advanced and/or metastatic disease
- Patient who is planned to have gemcitabine therapy at the proposed doses because he/she was not able to benefit from standard therapy and/or therapies known to provide clinical benefit or there is no standard therapy for the advanced and/or metastatic disease globally
- Have adequate organ function
- Have a performance status of 0-2 on the ECOG scale
- Have discontinued all previous therapies for cancer, including chemotherapy,cancer-related hormonal therapy, or other investigational therapy for at least 30 days (42 days for mitomycin C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy
- Prior radiation therapy for treatment of cancer is allowed to less than 25% of the bone marrow, and patients must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 30 days prior to study enrollment
- Have an estimated life expectancy of at least 12 weeks

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified