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A Phase 2 Study of XL647 in Subjects With Non-Small-Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Cancer

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Trial Information

A Phase 2 Study of XL647 in Subjects With Non-Small-Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

XL647-201

NCT ID:

NCT00364780

Start Date:

July 2006

Completion Date:

August 2010

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Carle Cancer CenterUrbana, Illinois  61801
University of ChicagoChicago, Illinois  60637
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Wayne University, Wertz Clinical Cancer Center, Karmanos CenterDetroit, Michigan  48201
Case Western Reserve University, University Hospitals of ClevelandCleveland, Ohio  44106