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Completed

NCT Number: NCT00415636

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 85258, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
  • 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.

Treatment and study plan

IC83/LY2603618

Drug

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.

Pemetrexed

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 25, 2006
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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