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

NCT00415636 | Completed Phase 1 Results

• 2 other identifiers: 11911I2I-MC-JMMB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.

  baseline up to 24 months

Secondary Outcomes (3)

• Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618

  Day 1 and Day 9 of Cycle 1

• 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

• Percentage of Participants With Best Overall Response

  baseline up to 24 months

Study Arms (6)

LY2603618 40 mg/m^2 (4.5-hour infusion)

EXPERIMENTAL

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.

Drug: IC83/LY2603618; Drug: pemetrexed

LY2603618 40 mg/m^2 (1-hour infusion)

EXPERIMENTAL

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.

Drug: IC83/LY2603618; Drug: pemetrexed

LY2603618 70 mg/m^2

EXPERIMENTAL

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.

Drug: IC83/LY2603618; Drug: pemetrexed

LY2603618 105 mg/m^2

EXPERIMENTAL

Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour.

Drug: IC83/LY2603618; Drug: pemetrexed

LY2603618 150 mg/m^2

EXPERIMENTAL

Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour.

Drug: IC83/LY2603618; Drug: pemetrexed

LY2603618 195 mg/m^2

EXPERIMENTAL

Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.

Drug: IC83/LY2603618; Drug: pemetrexed

Interventions

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.

LY2603618 40 mg/m^2 (1-hour infusion); LY2603618 40 mg/m^2 (4.5-hour infusion)

pemetrexed DRUG

pemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

Also known as: Alimta, LY231514

LY2603618 40 mg/m^2 (4.5-hour infusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 85258, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Neoplasms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 25, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-03

Locations

US (1)