Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions and delays to manage toxicity. Cabozantinib should be taken in fasting condition with no food for at least 2 hours before and 1 hour after taking the tablets. A high fat meal significantly increased the median tmax to 6 hours from 4 hours (fasted). The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled.

Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions (40mg 20mg) and delays to manage toxicity.

Cabozantinib 20 MG

Cabozantinib 40 MG

Cabozantinib 60 MG

Andrea Ardizzoni, MD

Giada Grilli, MD

Andrea Ardizzoni, DM

Francesco Gelsomino, DM

Karim Rihawi, DM

Hector Soto Parra, DM

Carlo Genova, DN

Carlo Genova, DM

Marina Chiara Garassino, DM

Linda Pallavicini

Marina Chiara Ganassino, DM

Danilo Rocco, DM

Giulia Pasello, DM

Raffaella Verrienti

Marcello Tiseo, DM

Roberta Camisa

Fausto Roila, DM

Antonio Chella, DM

Sabrina Vari, DM

Sonia Borrelli

Ciro Rossetto, dm

Ciro Rossetto, DM

This study is aimed to explore the antitumor activity, safety and efficacy profile of cabozantinib in pretreated, advanced RET-rearranged non-small cell lung cancer patients

Phase II Study With Cabozantinib in Patients With RET Positive NSCLC

"Phase II Study to Evaluate the Activity and Safety of Cabozantinib in Pretreated, Advanced RET-rearranged Non-small Cell Lung Cancer Patients: CRETA Trial"

Detection of RET aberration on DNA extracted from circulating tumor cells (CTCs) isolated in blood at baseline (optional)

Archival tumor tissue (FFPE tumor block or 7-10 unstained slides) will be assessed for determination of RET-rearrangment on tumor cells by using A FISH evaluation of the translocation will be performed using a break-apart probe for the 10p11 locus.

Exact binomial method will be used to estimate the response rate (CR+PR) and its 95% confidence interval.Proportion of patients presenting Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) based on the Investigator's assessment according to standard RECIST criteria v1.1. Patients with no tumor assessment after baseline will be classified as non-responders.

the assessment of safety will be based mainly on the frequency of adverse events; toxicity will be measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 4.03.

PFS will be calculated from the first treatment intake to the date of progressive disease, or death.

OS will be calculated from the first treatment intake to death from any cause.

DOR will be calculated from the first treatment intake to the date of disease progression or death.

DCR will be measured as the sum of complete and partial responses + stable disease.

Spots Global Cancer Trial Database for Phase II Study With Cabozantinib in Patients With RET Positive NSCLC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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