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.

AOU S.Orsola Malpighi-Unit of Oncologic Molecular and Transplantations Pathology

Bioikos Ambiente Srl

Ipsen

Mipharm SpA

University of Bologna

Professor/MD

Digestive System Diseases

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Drug: Cabozantinib Subjects who meet all study eligibility criteria will take tablets containing 60 mg of cabozantinib once daily orally. Required dose reductions will be in decrements of 20 mg cabozantinib (maximum two dose reductions).

• The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2):

* 60 mg qd to 40 mg qd (level 1)
* 40 mg qd to 20 mg qd (level 2)

Lorenza Rimassa, MD

Nicola Personeni, MD

This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

Subjects who meet all study eligibility criteria will take tablets containing 60 mg of cabozantinib once daily orally. Required dose reductions will be in decrements of 20 mg cabozantinib (maximum two dose reductions).

Subjects will receive study treatment as long as they continue to experience clinical benefit in the opinion of the investigator or until there is unacceptable toxicity.

Primary objective of this study is to evaluate the efficacy of cabozantinib, given as second- or third-line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors.

Secondary objectives for this study are as follows:

* To evaluate the activity of cabozantinib, in terms of ORR (CR+PR) as per RECIST 1.1, duration of response, time to treatment failure (TTF), time to progression (TTP), and OS
* To evaluate the safety and tolerability of cabozantinib

Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma Progressing on or Intolerant to Prior Treatment With Immune Checkpoint Inhibitors: A Phase II Study (Immunocabo)

PFS on cabozantinib treatment (considering as PFS events: clinical or radiological progressive disease, per RECIST 1.1, or death).

ORR as per RECIST 1.1, duration of response, TTF, TTP, and OS.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study With Cabozantinib in Patients With RET Positive NSCLC	NCT04131543	Non Small Cell ...	Cabozantinib 20... Cabozantinib 40... Cabozantinib 60...	18 Years -	University of Bologna
Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma	NCT04435977	Hepatocarcinoma	Cabozantinib 60...	18 Years - 99 Years	Istituto Clinico Humanitas
Phase II Study With Cabozantinib in Patients With RET Positive NSCLC	NCT04131543	Non Small Cell ...	Cabozantinib 20... Cabozantinib 40... Cabozantinib 60...	18 Years -	University of Bologna

Spots Global Cancer Trial Database for cabozantinib 60 mg