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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: IC83/LY2603618; Drug: pemetrexed

• Registration Number: NCT00415636
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-25
• Study Start: 2007-01
• Primary Completion: 2010-03
• Study Completion: 2010-07
• Results First Submitted: 2018-02-17
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Results First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY2603618 70 mg/m^2	IC83/LY2603618	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.
LY2603618 40 mg/m^2 (4.5-hour infusion)	IC83/LY2603618	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.
LY2603618 40 mg/m^2 (1-hour infusion)	IC83/LY2603618	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.
LY2603618 150 mg/m^2	IC83/LY2603618	Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
LY2603618 105 mg/m^2	IC83/LY2603618	Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
LY2603618 195 mg/m^2	IC83/LY2603618	Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
LY2603618 40 mg/m^2 (4.5-hour infusion)	pemetrexed	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.
LY2603618 40 mg/m^2 (1-hour infusion)	pemetrexed	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.
LY2603618 70 mg/m^2	pemetrexed	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.
LY2603618 105 mg/m^2	pemetrexed	Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
LY2603618 150 mg/m^2	pemetrexed	Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
LY2603618 195 mg/m^2	pemetrexed	Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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 Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618	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-∞])	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	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.

Trial Locations

Locations (1)

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