Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib

Study Overview
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Brief Summary
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The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.

Official Title
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A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: XL647


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of unresectable Stage IIIB or Stage IV relapsed or recurrent NSCLC. Subjects must have: documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR a documented T790M EGFR mutation Measurable disease defined according to RECIST ECOG performance status of 0 or 1. Sexually active subjects must use an accepted method of contraception during the course of the study. Female subjects of childbearing potential must have a negative pregnancy test at enrollment. Exclusion Criteria: Received radiation to ≥25% of his or her bone marrow within 30 days of XL647 treatment. Received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug. Received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug. Receiving anticoagulation therapy with warfarin. Not recovered to Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment. Corrected QT interval (QTc) of >0.45 seconds. Progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases. Requires steroid or anticonvulsant therapy for the treatment of brain metastases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: XL647<br>* Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets<br>* Other names: KD019;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the best confirmed response rate |  | Inclusion until disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of XL647 administered daily |  | First treatment until 30 day post last treatment | 
| Progression-free survival, duration of response, and overall survival |  | Incusion until disease progression | 
| Further characterize the pharmacokinetic (PK) parameters |  | Every 8 weeks after Day 57 until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small-Cell Lung Cancer