Clinical trial NCT00522145: Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small-Cell Lung Cancer
Lead sponsor: Kadmon Corporation, LLC
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the best confirmed response rate
timeFrame: Inclusion until disease progression
Secondary outcomes:
measure: Safety and tolerability of XL647 administered daily
timeFrame: First treatment until 30 day post last treatment
measure: Progression-free survival, duration of response, and overall survival
timeFrame: Incusion until disease progression
measure: Further characterize the pharmacokinetic (PK) parameters
timeFrame: Every 8 weeks after Day 57 until disease progression
Other outcomes:
Locations:
city: Gilroy
country: United States
facility: Ronald Yanagihara
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Stanford
country: United States
facility: Oncology Division and General Clincial Research, Stanford University Medical Center
state: California
city: New Albany
country: United States
facility: Cancer Care Center, Inc. P.C.
state: Indiana
city: Hagerstown
country: United States
facility: Washington County Hospital, The Center for Clinical Research
state: Maryland
city: Detroit
country: United States
facility: Wayne State University, Wertz Clinical Cancer Center, Karmanos Center
state: Michigan
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New Bern
country: United States
facility: New Bern Cancer Care Oncology
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University, University Hospitals of Cleveland
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
Study officials:
References:
citation: 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.