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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415636
• Other study ID #: 11911
• Secondary ID: I2I-MC-JMMB
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: July 2010

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• IC83/LY2603618
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.
• IC83/LY2603618
70 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
• IC83/LY2603618
105 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
• IC83/LY2603618
150 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
• IC83/LY2603618
195 mg/m^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.
• pemetrexed
pemetrexed 500 mg/m^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
• pemetrexed
pemetrexed 500 mg/m^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618	Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.	Day 1 and Day 9 of Cycle 1
Secondary	Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8])	AUC[0-8] was calculated from the plasma concentration data of LY2603618 versus time profiles.	Day 1 and Day 9 of Cycle 1
Secondary	Percentage of Participants With Best Overall Response	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.	baseline up to 24 months

External Links

•   Lilly Clinical Trial Registry