None listed
Conditions
Interventions
Lonafarnob Type of group
Oral Lonafamib in a dose of 100 mg BID in combination with paclitaxel (175 mg / m2 IV every 21 days) and carboplatin (AUC of 6 IV every 21 days)
Group name:Placebo Type of group
Oral placebo BID in combination with paclitaxel (225mg / m2 IV every 21 days) and carboplatin (AUC of 6 IV every 21 days).
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: Male or female Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol. Age greater than or equal to 18 years old ECOG performance status of 0 to 1 Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified. Meets protocol requirements for specified laboratory values Written informed consent Appropriate use of effective contraception if of childbearing potential Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease
Exclusion criteria
Exclusion criteria: Prior chemotherapy for any stage of NSCLC Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy Concurrent treatment or treatment within the last 2 years for any other malignancy Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication) Medical conditions that would interfere with taking oral medications Patients with bone metastases as the only site of disease Pregnant or nursing women Known HIV positivity or AIDS-related illness Patients with significant QTc prolongation at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Comparison of the general survival (OS) in the population with the intention of treating the two treatment regimens by means of the stratified test of the logarithmic order. Measure:To compare the overall survival (OS) of patients diagnosed with non-small cell lung cancer (NSCLC) Stage 3b or 4 treated with lonafamib in combination with paditaxel and carboplatin with that of placebo-treated patients combined with paclitaxel and carboplatin. Timepoints:every 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Full serum blood platelet biochemistry and summary summary of the adverse event profile of patients in each group in terms of frequency and number of events. Measure:To compare safety and determine the pharmacodynamic markers of biochemical activity (HDJ-2) and pharmacodynamic activity (PK) in a subgroup of patients. Timepoints:every 6 weeks | — |
Countries
Peru, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed