Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Pemetrexed

Criteria

Inclusion Criteria:

• Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

• Has fully recovered from all toxicities due to the following:

1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.

2. Surgery.

• Has a life expectancy of at least 3 months.

• Negative serum pregnancy test.

Exclusion Criteria:

• Is pregnant or breastfeeding.

• Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.

• Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.

• Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.

• Has a known active infection.