Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT02132598|
Recruitment Status : Recruiting
First Posted : May 7, 2014
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer (NSCLC) Metastases to the Brain||Drug: cabozantinib||Phase 2|
This is a Phase 2, single-arm, open-label study of cabozantinib in subjects with molecularly unselected Non-Small Cell Lung Cancer (NSCLC) with metastases to the brain and in patients with c-MET amplified Non-Small Cell Lung Cancer (NSCLC) with metastases to the brain.
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.
The primary endpoint is Overall Response Rate (ORR) in both the unselected NSCLC population and the molecularly selected patients on the basis of c-MET amplification.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Phase II Clinical Trial of Cabozantinib (XL184) in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases With and Without C Met Amplification|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2024|
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
- To assess the Overall Response Rate (ORR) [ Time Frame: 12 months ]
- To assess the Disease Control Rate (DCR) [ Time Frame: 16 weeks ]
- To assess the Progression-free Survival (PFS) [ Time Frame: 12 months ]
- To assess the Overall Survival (OS) [ Time Frame: 24 months ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Monitor AE's continuously during study and for 30 days after the last dose of study treatment and SAE's assessed as related to study treatment until resolution ]
Seriousness, severity/ grade and relationship to study treatment will be assessed by the investigator. Severity/ grade will be defined by the National Cancer Institute (NCI) CTCAE v4.0.
Subjects will be monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment and for any serious adverse event (SAE) assessed as related to study treatment or study procedures, even if the SAE occurs more than 30 days after the last dose of study treatment.
- Time to Progression (TTP) of intra-cranial disease [ Time Frame: Baseline at 28 days prior to 1st dose, then every 8 weeks till Progressive Disease followed by every 12 weeks for 5 years ]
For this study, computed tomography scans will be performed every 8 weeks for assessment of extra-cranial disease. An MRI of the brain with contrast (or CT brain with contrast in patients who are unable to obtain an MRI, e.g., has a pacemaker) will be performed every 8 weeks to assess intracranial disease.
In patients whose first site of disease progression is extra-cranial disease, a brain MRI (or CT brain with contrast in patients who are unable to obtain an MRI) will be performed at the time of extra-cranial disease progression and every 12 weeks in the study follow-up period.
Subjects continuing to show benefit, (complete response [CR], partial response [PR], or stable disease [SD]) as defined by RECIST v1.1 may continue on study. Subjects with PD as defined by RECIST v1.1 should have their treatment discontinued, and they should enter the post-treatment phase of the study. The same method for tumor assessment should be employed at every assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132598
|Contact: Liza Villaruz, MDfirstname.lastname@example.org|
|Contact: Carrie Muniz, RNemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute- Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Carrie Muniz, RN, BSN 412-623-6121 firstname.lastname@example.org|
|Principal Investigator:||Liza Villaruz, MD||UPCI Department Hematology-Oncology|