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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: XL647

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Gilroy, California, United States, 95020
      • Ronald Yanagihara
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
    • Stanford, California, United States, 94305
      • Oncology Division and General Clincial Research, Stanford University Medical Center
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Cancer Care Center, Inc. P.C.
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Washington County Hospital, The Center for Clinical Research
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University, Wertz Clinical Cancer Center, Karmanos Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
  • North Carolina
    • New Bern, North Carolina, United States, 28560
      • New Bern Cancer Care Oncology
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, University Hospitals of Cleveland
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kadmon Corporation, LLC

Publications and helpful links

General Publications

• Pietanza MC, Lynch TJ Jr, Lara PN Jr, Cho J, Yanagihara RH, Vrindavanam N, Chowhan NM, Gadgeel SM, Pennell NA, Funke R, Mitchell B, Wakelee HA, Miller VA. XL647--a multitargeted tyrosine kinase inhibitor: results of a phase II study in subjects with non-small cell lung cancer who have progressed after responding to treatment with either gefitinib or erlotinib. J Thorac Oncol. 2012 Jan;7(1):219-26. doi: 10.1097/JTO.0b013e31822eebf9.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: August 27, 2007
• First Submitted That Met QC Criteria: August 27, 2007
• First Posted (Estimate): August 29, 2007

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Non-Small-Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; XL647
• Other Study ID Numbers: XL647-203