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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-02-28

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.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type EXPERIMENTAL

XL647

Intervention Type DRUG

Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets

Interventions

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XL647

Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets

Intervention Type DRUG

Other Intervention Names

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KD019

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:

1. 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
2. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No