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

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ClinicalTrials.gov Identifier: NCT00415636
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

Condition or disease Intervention/treatment Phase
Cancer Drug: IC83/LY2603618 Drug: pemetrexed Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of IC83/LY2603618 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters will be determined. [ Time Frame: 24 months ]
  2. Antitumor activity will be observed. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00415636     History of Changes
Other Study ID Numbers: 11911
I2I-MC-JMMB ( Other Identifier: Eli Lilly and Company )
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors