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
  Purpose

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


Condition Intervention Phase
Cancer
Drug: IC83/LY2603618
Drug: pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Safety and Tolerability of IC83/LY2603618 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415636

Locations
United States, Arizona
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.
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00415636     History of Changes
Other Study ID Numbers: 11911, I2I-MC-JMMB
Study First Received: December 21, 2006
Last Updated: August 30, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014