Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain Metastases

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Liza Villaruz, MD
Study ID
NCT02132598
Phase
PHASE2
Status
Terminated

Conditions

  • Metastases to the Brain
  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an open-label phase II clinical trial designed to allow a preliminary assessment of the efficacy and safety of cabozantinib in unselected Non-Small Cell Lung Cancer (NSCLC) patients with metastases to the brain and in the subset of patients with c-MET amplified Non-Small Cell Lung Cancer with metastases to the brain. Previously treated patients with non-squamous NSCLC who have had brain metastases at any point in their treatment history are eligible for enrollment on this clinical trial. Patients with clinically asymptomatic untreated brain metastases will be allowed on trial at the discretion of the treating investigator. Patients who have undergone treatment for their brain metastases with Whole-Brain Radiation Therapy (WBRT), stereotactic radiosurgery (SRS) or surgery must be clinically stable and recovered from all procedures at the time of study enrollment.

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2021
Primary completion
Aug 9, 2019
Completion
Aug 9, 2019

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib (XL184)
    Patients will receive cabozantinib at 60 mg orally once daily and continue on treatment until disease progression, death or unacceptable adverse events. Treatment cycles are 4 weeks in duration

Primary Outcome Measure

Overall Response [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer Institute- Hillman Cancer CenterPittsburghPennsylvania15232-

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By research site
University of Pittsburgh Cancer Institute- Hillman Cancer Center· Pittsburgh, PA

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