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A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer


Inclusion Criteria:



- Has at least one lesion that can be evaluated by RECIST

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

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of IC83/LY2603618

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11911

NCT ID:

NCT00415636

Start Date:

December 2006

Completion Date:

July 2010

Related Keywords:

  • Cancer

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Phoenix, Arizona  85012