Phase II Study With Cabozantinib in Patients With RET Positive NSCLC

PHASE2UnknownINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 7, 2019

Primary Completion Date

August 7, 2020

Study Completion Date

August 7, 2022

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Cabozantinib 20 MG

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.

DRUG

Cabozantinib 40 MG

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.

DRUG

Cabozantinib 60 MG

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.

Trial Locations (11)

16132

NOT_YET_RECRUITING

Oncologia Medica 2 -Policlinico San Martino, Genova

20133

NOT_YET_RECRUITING

S.S. di Oncologia Medica toraco-polmonare - Fondazione IRCCS - Istituto Nazionale Tumori, Milan

33100

NOT_YET_RECRUITING

UOC di Oncologia Medica - Azienda Sanitaria Universitaria Integrata di Udine, Udine

35128

NOT_YET_RECRUITING

UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto, Padua

40138

RECRUITING

OU di Oncologia Medica- Azienda ospedaliero-Universitaria S. Orsola Malpighi, Bologna

43126

NOT_YET_RECRUITING

UOC di Oncologia Medica- Azienda Ospidaliero Universitaria di Parma, Parma

56126

NOT_YET_RECRUITING

UO Pneumologia - A.O.U Pisana, Pisa

80131

NOT_YET_RECRUITING

U.O.C Pneumologia ad Indirizzo Oncologico -AORN Ospedali dei Colli Monaldi-Cotugno-CTO, Napoli

95125

NOT_YET_RECRUITING

U.O di Oncologia Medica Policlinico V.Emanuele-G.Rodolico, Catania

06132

NOT_YET_RECRUITING

US di Oncologia Medica - A.O. di Perugia, Perugia

00144

NOT_YET_RECRUITING

S.C. di Oncologia Medica - IFO - Istituto Regina Elena, Roma

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

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

UNKNOWN

collaborator

Bioikos Ambiente Srl

OTHER

collaborator

Ipsen

INDUSTRY

collaborator

Mipharm SpA

UNKNOWN

lead

University of Bologna

OTHER

NCT04131543 - Phase II Study With Cabozantinib in Patients With RET Positive NSCLC | Biotech Hunter | Biotech Hunter