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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
History of Changes
  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:

U.S. FDA Resources

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 
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
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016