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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: XL647

• Registration Number: NCT00522145
• Lead Sponsor: Kadmon Corporation, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-29
• Primary Completion: 2009-10
• Study Completion: 2010-02
• Disposition First Submitted: 2012-01-24
• Disposition First Submitted QC: 2012-01-24
• Disposition First Posted: 2012-01-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	XL647	-

Primary Outcome Measures

Name	Time	Method
Determine the best confirmed response rate	Inclusion until disease progression

Secondary Outcome Measures

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

Trial Locations

Locations (10)

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

Cancer Care Center, Inc. P.C.; 🇺🇸 New Albany, Indiana, United States

Ronald Yanagihara; 🇺🇸 Gilroy, California, United States

Oncology Division and General Clincial Research, Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Signal Point Clinical Research Center; 🇺🇸 Middletown, Ohio, United States

Washington County Hospital, The Center for Clinical Research; 🇺🇸 Hagerstown, Maryland, United States

Wayne State University, Wertz Clinical Cancer Center, Karmanos Center; 🇺🇸 Detroit, Michigan, United States

New Bern Cancer Care Oncology; 🇺🇸 New Bern, North Carolina, United States

Case Western Reserve University, University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States