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

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

Status
Unknown
Phases
Phase 1
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2080221454
Enrollment
Unknown
Registered
2011-05-10
Start date
2011-05-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

investigational material(s) Generic name etc : LY2603618 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026