Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Pemetrexed and Cisplatin plus Enzastaurin versus Pemetrexed and Cisplatin plus Placebo in Chemonaive Patients with Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer - N/A

Eli Lilly and Company limited0 sites120 target enrollmentAugust 17, 2007

Conditionsadvanced, unresectable, or metastatic (stage IIIB or IV) nonsquamous non-small cell lung cancer

DrugsALIMTA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: advanced, unresectable, or metastatic (stage IIIB or IV) nonsquamous non-small cell lung cancer
Sponsor: Eli Lilly and Company limited
Enrollment: 120
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 17, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company limited

Eligibility Criteria

Inclusion Criteria

•Patients are eligible to be included from the study if they meet all of the following criteria:
•\[1] Have histologic or cytologic diagnosis of advanced NSCLC (Stage IIIB disease with pleural effusion and/or positive supraclavicular nodes, or Stage IV disease)
•In addition, patients enrolling in Part 2 of the study should have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
•\[2] No prior systemic chemotherapy, pleurodesis with chemotherapy, immunotherapy, targeted or biological therapy for this disease
•\[3] Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan, OR nonmeasurable disease, defined according to RECIST
•\[4] Prior radiation therapy is allowed to \<25% of the bone marrow; however prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment. Patients must have recovered from the acute toxic effects prior to study enrollment
•\[5] Have a performance status of 0 or 1 on the Eastern Cooperative Oncology group (ECOG) scale
•\[6] Must sign an informed consent document (or legal representative has given informed consent)
•\[7] Male or female patients at least 18 years of age
•\[8] Females of child\-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and his or her health care team, during the study and for 6 months following the last dose of study treatment

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following criteria:
•\[10] Have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
•\[11] Have active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy
•\[12] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
•\[13] Have documented central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study treatment). A screening CT or MRI before enrollment in the absence of a clinical suspicion of brain metastases is not required.
•\[14] Have had myocardial infarction occurring \<6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications (refer to the New York Heart Association Class III or IV)
•\[15] Have peripheral neuropathy of NCI CTCAE Grade 2 or above
•\[16] Are unable or unwilling to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
•\[17] Are pregnant or breast feeding
•\[18] Are unable to swallow tablets.