Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).

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Detailed Description

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Conditions

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Non-small-cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients received XL647 at an intermittent dosing schedule receiving drug for 5 days followed by 9 days without drug.

Group Type EXPERIMENTAL

XL647

Intervention Type DRUG

XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 \& 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.

2

Patients received drug at a daily dosing schedule

Group Type EXPERIMENTAL

XL647

Intervention Type DRUG

XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 \& 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.

Interventions

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XL647

XL647 will be administered orally as a single agent. XL647 will be supplied as 50 mg tablets. Subjects in the Intermittent 5 \& 9 cohort will receive XL647 at a dose of 350 mg on a 5 days on and 9 days off cycle every 2 weeks for 8 weeks. Subjects in the Daily Dosing cohort will receive XL647 administered daily as a single oral dose of 300 mg. In the absence of progressive disease (PD) and unacceptable XL647-related toxicity, subjects may continue to receive XL647 treatment on their assigned dosing schedule for up to 1 year on this study. Subjects who reach 1 year of treatment with no evidence of disease progression may, with the concurrence of the investigator and the sponsor, continue to receive therapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
* Measurable disease defined according to RECIST
* ECOG performance status of 0 or 1
* Normal organ and marrow function
* No other malignancies within 5 years, except for non-melanoma skin cancer

Exclusion Criteria

* Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
* Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
* Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered \> 30 days before study enrollment
* Receiving anticoagulation therapy with warfarin (low-dose warfarin \< 1 mg/day, heparin and low molecular weight heparins are permitted)
* The subject meets any of the following cardiac criteria:

* Corrected QT interval (QTc) of \> 460 msec
* Family history of congenital long QT syndrome or unexplained sudden death
* History of sustained ventricular arrhythmias
* Has a finding of left bundle branch block
* Has an obligate pacemaker
* Has important bradycardia defined as a heart rate of \< 50 bpm due to sinus node dysfunction
* Has uncontrolled hypertension
* Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
* Has a serum potassium or serum magnesium level that falls outside the normal range
* The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
* Uncontrolled intercurrent illness
* Subject is pregnant or breastfeeding
* Known HIV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No