Trial record 1 of 1 for:    IC83 and Pemetrexed
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Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00415636
First received: December 21, 2006
Last updated: August 30, 2010
Last verified: August 2010

December 21, 2006
August 30, 2010
December 2006
March 2010   (final data collection date for primary outcome measure)
Safety and Tolerability of IC83/LY2603618 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Safety and Tolerability of IC83
Complete list of historical versions of study NCT00415636 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters will be determined. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Antitumor activity will be observed. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Pharmacokinetic Parameters will be determined. Efficacy endpoints will include tumor response, time to radiologic or clinical tumor progression, and progression free survival
Not Provided
Not Provided
 
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: IC83/LY2603618
    40 mg/m2 day 1 and day 9 cycle 1, day 2 of subsequent cycles, unlimited 21 day cycles. Dose finding study: dose is escalated after a minimum of 6 patients receive 40 mg/m2.
  • Drug: pemetrexed
    pemetrexed 500 mg/m2, IV, day 8 of cycle 1, day one of subsequent cycles, unlimited 21 day cycles
    Other Names:
    • Alimta
    • LY231514
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
July 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00415636
11911, I2I-MC-JMMB
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP