Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments ly2603618, pemetrexed
Phase phase 2
Sponsor Eli Lilly and Company
Start date November 2009
End date July 2012
Trial size 60 participants
Trial identifier NCT00988858, 12092, I2I-MC-JMMD

Summary

The primary purpose of this study is to evaluate the safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in patients with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ly2603618
150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
pemetrexed Alimta
500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression

Primary Outcomes

Measure
Overall Tumor Response
time frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation

Secondary Outcomes

Measure
Percentage of Patients Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
time frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation
Progression-free survival (PFS)
time frame: Baseline to Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation
Duration of Response
time frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation
Pharmacokinetics: Area Under Curve (AUC) of LY2603618 and Pemetrexed
time frame: Predose through Cycle 2 at Specified Timepoints
Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)
time frame: Baseline through Progressive Disease or Study Discontinuation
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2603618 and Pemetrexed
time frame: Predose through Cycle 2 at Specified Timepoints

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must agree to have a tumor biopsy at screening - Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment - Must be available for the duration of the study and willing to follow the study procedures - If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug - Must have discontinued radiation therapy at least 4 weeks before entering this study Exclusion Criteria: - Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment. - Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child. - Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). - Must not have previously participated in a study involving LY2603618 - Must not have previously taken pemetrexed for cancer - Must not have a known allergy to LY2603618 or pemetrexed - Must not currently have an infection that may affect patient's ability to tolerate the therapy - Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease - If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines

Additional Information

Official title A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.