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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415636
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 21, 2006
First Posted Date  ICMJE December 25, 2006
Results First Submitted Date  ICMJE February 17, 2018
Results First Posted Date  ICMJE October 19, 2018
Last Update Posted Date October 19, 2018
Study Start Date  ICMJE January 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
Number of Participants With Adverse Events (AEs) [ Time Frame: baseline up to 24 months ]
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
Safety and Tolerability of IC83
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 [ Time Frame: Day 1 and Day 9 of Cycle 1 ]
    Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
  • Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) [ Time Frame: Day 1 and Day 9 of Cycle 1 ]
    AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.
  • Percentage of Participants With Best Overall Response [ Time Frame: baseline up to 24 months ]
    Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
Pharmacokinetic Parameters will be determined. Efficacy endpoints will include tumor response, time to radiologic or clinical tumor progression, and progression free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: IC83/LY2603618
    40 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m^2.
  • Drug: IC83/LY2603618
    70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
  • Drug: IC83/LY2603618
    105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
  • Drug: IC83/LY2603618
    150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
  • Drug: IC83/LY2603618
    195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
  • Drug: pemetrexed
    pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
    Other Names:
    • Alimta
    • LY231514
  • Drug: pemetrexed
    pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
Study Arms  ICMJE
  • Experimental: LY2603618 40 mg/m^2 (4.5-hour infusion)
    LY2603618 40 milligrams per square meter (mg/m^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
  • Experimental: LY2603618 40 mg/m^2 (1-hour infusion)
    Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m^2 [4.5-hour infusion]), the LY2603618 40 mg/m^2 dose in Cohort 2 (LY2603618 40 mg/m^2 [1-hour infusion]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
  • Experimental: LY2603618 70 mg/m^2
    Beginning with Cohort 3 (LY2603618 70 mg/m^2), dose modifications were allowed. LY2603618 70 mg/m^2 was administered over the course of 1 hour.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
  • Experimental: LY2603618 105 mg/m^2
    Cohort 4: LY2603618 105 mg/m^2 administered over the duration of 1 hour.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
  • Experimental: LY2603618 150 mg/m^2
    Cohort 5: LY2603618 150 mg/m^2 administered over the duration of 1 hour.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
  • Experimental: LY2603618 195 mg/m^2
    Cohort 6: LY2603618 195 mg/m^2 administered over the duration of 1 hour.
    Interventions:
    • Drug: IC83/LY2603618
    • Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2010)
31
Original Enrollment  ICMJE
 (submitted: December 21, 2006)
80
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00415636
Other Study ID Numbers  ICMJE 11911
I2I-MC-JMMB ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 2018

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