- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131543
Phase II Study With Cabozantinib in Patients With RET Positive NSCLC (CRETA)
"Phase II Study to Evaluate the Activity and Safety of Cabozantinib in Pretreated, Advanced RET-rearranged Non-small Cell Lung Cancer Patients: CRETA Trial"
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- OU di Oncologia Medica- Azienda ospedaliero-Universitaria S. Orsola Malpighi
-
Contact:
- Andrea Ardizzoni, MD
- Phone Number: 0512142206
- Email: andrea.ardizzoni2@unibo.it
-
Contact:
- Giada Grilli, MD
- Phone Number: 0512142204
- Email: giada.grilli2@unibo.it
-
Principal Investigator:
- Andrea Ardizzoni, DM
-
Sub-Investigator:
- Francesco Gelsomino, DM
-
Sub-Investigator:
- Karim Rihawi, DM
-
Catania, Italy, 95125
- Not yet recruiting
- U.O di Oncologia Medica Policlinico V.Emanuele-G.Rodolico
-
Contact:
- Hector Soto Parra, DM
- Phone Number: 953782426
- Email: hsotoparra@yahoo.it
-
Principal Investigator:
- Hector Soto Parra, DM
-
Genova, Italy, 16132
- Not yet recruiting
- Oncologia Medica 2 -Policlinico San Martino
-
Contact:
- Carlo Genova, DN
- Phone Number: 0105558918
- Email: carlo.genova@hsanmartino.it
-
Principal Investigator:
- Carlo Genova, DM
-
Milano, Italy, 20133
- Not yet recruiting
- S.S. di Oncologia Medica toraco-polmonare - Fondazione IRCCS - Istituto Nazionale Tumori
-
Contact:
- Marina Chiara Garassino, DM
- Phone Number: +390223903813
- Email: marina.garassino@istitutotumori.mi.it
-
Contact:
- Linda Pallavicini
- Phone Number: +390223903836
- Email: linda.pallavicini@istitutotumori.mi.it
-
Principal Investigator:
- Marina Chiara Ganassino, DM
-
Napoli, Italy, 80131
- Not yet recruiting
- U.O.C Pneumologia ad Indirizzo Oncologico -AORN Ospedali dei Colli Monaldi-Cotugno-CTO
-
Contact:
- Danilo Rocco, DM
- Email: clinicaltrialsrocco@gmail.com
-
Principal Investigator:
- Danilo Rocco, DM
-
Padova, Italy, 35128
- Not yet recruiting
- UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto
-
Contact:
- Giulia Pasello, DM
- Phone Number: 0498215931
- Email: giulia.pasello@ioveneto.it
-
Contact:
- Raffaella Verrienti
- Phone Number: 0498215608
- Email: raffaella.verrienti@ioveneto.it
-
Principal Investigator:
- Giulia Pasello, DM
-
Parma, Italy, 43126
- Not yet recruiting
- UOC di Oncologia Medica- Azienda Ospidaliero Universitaria di Parma
-
Contact:
- Marcello Tiseo, DM
- Phone Number: 052170266061
- Email: mtiseo@ao.pr.it
-
Contact:
- Roberta Camisa
- Phone Number: 052170266061
- Email: rcamisa@ao.pr.it
-
Principal Investigator:
- Marcello Tiseo, DM
-
Perugia, Italy, 06132
- Not yet recruiting
- US di Oncologia Medica - A.O. di Perugia
-
Contact:
- Fausto Roila, DM
- Phone Number: 0755784099
- Email: roila.fausto@libero.it
-
Principal Investigator:
- Fausto Roila, DM
-
Pisa, Italy, 56126
- Not yet recruiting
- UO Pneumologia - A.O.U Pisana
-
Contact:
- Antonio Chella, DM
- Phone Number: +3950996653
- Email: anto.kell@tiscali.it
-
Principal Investigator:
- Antonio Chella, DM
-
Roma, Italy, 00144
- Not yet recruiting
- S.C. di Oncologia Medica - IFO - Istituto Regina Elena
-
Contact:
- Sabrina Vari, DM
- Phone Number: +39-06-52662752
- Email: sabrina.vari@ifo.gov.it
-
Contact:
- Sonia Borrelli
- Phone Number: +39-06-52662752
- Email: sonia.borrelli@ifo.gov.it
-
Principal Investigator:
- Sabrina Vari, DM
-
Udine, Italy, 33100
- Not yet recruiting
- UOC di Oncologia Medica - Azienda Sanitaria Universitaria Integrata di Udine
-
Contact:
- Ciro Rossetto, dm
- Phone Number: +39432559330
- Email: cirorossetto@asuiud.sanita.fvg.it
-
Principal Investigator:
- Ciro Rossetto, DM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Locally advanced, relapsed or metastatic non-small cell lung cancer - stage IIIB/IV according to 7th International Association for the Study of Lung Cancer (IASLC) classification
- Ability to understand and willingness to sign informed consent prior to initiation of any study procedures.
- Pathologically (histology or cytology) confirmed diagnosis of non- small cell lung carcinoma.
- RET gene rearrangement by local laboratory analysis with an approved standard method (FISH or Next Generation Sequencing Panel). An archival tumor sample must be available for central laboratory confirmation.
- Male or female and = 18 years of age
- Life expectancy = 12 weeks
- Have progressed after or during at least one standard anticancer treatment
- Have measurable disease as per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1); clear radiological evidence of disease progression after first-line therapy must be documented; no previous radiotherapy on the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
Subjects must have adequate organ function including the following:
- Absolute neutrophil count > 1.5 x 10^9/L
- Platelet count > 100 x 10^9/L
- Haemoglobin > 90 g/L
- ALT < 2.5 times the upper limit of normal (ULN)
- AST < 2.5 times ULN
- Total bilirubin <1.5 times ULN
- Creatinine <1.5 times ULN concurrent with creatinine clearance > 50 ml/min (measured or calculated by Cockcroft and Gault equation, confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN)
- Lipase < 2.0 times the upper limit of normal (ULN)
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria
- Recovered (i.e., = Grade 1 toxicity) from effects of prior anticancer therapy, except alopecia
- No radiologic or clinical evidence of acute or chronic pancreatitis
- For Females: must be postmenopausal (defined as amenhorrea = 12 consecutive months) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test obtained within 3 days before starting study treatment has to be documented; furthermore, patients must agree to adopt 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 4 months after the last dose of study drug.
- For Males: even if surgically sterilized (i.e. post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug.
- Ability to comply with protocol requirement.
Exclusion criteria:
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- Previous treatment with cabozantinib.
- Gastrointestinal disorders likely to interfere with absorption of the study drug.
- Subjects with gastrointestinal disorders associated with a high risk of perforation of fistula formation.
- Subjects with active peptic ulcer or with a history of clinically ¿significant GI bleeding within 6 months before the first dose of study treatment.
- Patients requiring full-dose anticoagulation therapy any time prior to enrollment.
- Current use of aspirin, clopidogrel, ticlopidine.
- Patients with tumors invading major pulmonary vessels and/or with cavitating pulmonary lesions.
- Major surgery within the last four weeks. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
- Subjects with clinical or radiological signs of pulmonary hemorrhage within 3 months before the first dose of study treatment.
Symptomatic CNS or leptomeningeal lesions, not previously treated with radiotherapy.
Untreated central nervous system (CNS) or leptomeningeal metastases are allowed if asymptomatic. Patients with symptomatic CNS or leptomeningeal lesions will be allowed to participate in this study if previously treated with radiotherapy and on stable dose of corticosteroids and/or anticonvulsants for > 10 days or not requiring such medication.
Radiotherapy must have been completed a minimum of 4 weeks prior to registration, and patients must have recovered from AEs related to radiotherapy to < grade 1 (except alopecia).
- History of congenital platelet function defect.
- Patient unable to swallow tablets
- Corrected QT interval greater than 500 ms (Fridericia formula)
Clinically significant, uncontrolled heart diseases:
- Unstable angina within 6 months prior to screening
- Myocardial infarction within 6 months prior to screening
- History of documented congestive heart failure
- Uncontrolled hypertension defined by a Systolic Blood Pressure , with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
- Ventricular arrhythmias, Supraventricular and nodal arrhythmias not controlled with medication
- Congenital history of QT syndrome.
- Diagnosed with or treated for another malignancy within 3 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type may be enrolled in the study if they have undergone complete resection and no evidence of active disease is present.
- Any type of systemic anticancer agent within 3 weeks of first dose of study treatment, or within 5 half- lives of the agent whichever is shorter (subjects on LHRH or GnRH agonists may be maintained on these agents)
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Rare hereditary problems of
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cabozantinib
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (RR)
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
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.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity (frequency of adverse events)
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
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.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Progression-Free Survival (PFS)
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
PFS will be calculated from the first treatment intake to the date of progressive disease, or death.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Overall survival (OS)
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
OS will be calculated from the first treatment intake to death from any cause.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Duration of response (DOR
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
DOR will be calculated from the first treatment intake to the date of disease progression or death.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Disease Control Rate(DCR)
Time Frame: From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
DCR will be measured as the sum of complete and partial responses + stable disease.
|
From the start of treatment ( Baseline) to the progression of Disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RET aberration
Time Frame: On the start of treatment (Baseline) and through study completion, an average of 1 year
|
Detection of RET aberration on DNA extracted from circulating tumor cells (CTCs) isolated in blood at baseline (optional)
|
On the start of treatment (Baseline) and through study completion, an average of 1 year
|
RET-rearrangment on tumor tissue
Time Frame: At the start of treatment (baseline)
|
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.
|
At the start of treatment (baseline)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.
- Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.
- Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, Feldman DR, Olencki T, Picus J, Small EJ, Dakhil S, George DJ, Morris MJ. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. J Clin Oncol. 2017 Feb 20;35(6):591-597. doi: 10.1200/JCO.2016.70.7398. Epub 2016 Nov 14. Erratum In: J Clin Oncol. 2017 Nov 10;35(32):3736. J Clin Oncol. 2018 Feb 10;36(5):521.
- Takeuchi K, Soda M, Togashi Y, Suzuki R, Sakata S, Hatano S, Asaka R, Hamanaka W, Ninomiya H, Uehara H, Lim Choi Y, Satoh Y, Okumura S, Nakagawa K, Mano H, Ishikawa Y. RET, ROS1 and ALK fusions in lung cancer. Nat Med. 2012 Feb 12;18(3):378-81. doi: 10.1038/nm.2658.
- Kodama T, Tsukaguchi T, Satoh Y, Yoshida M, Watanabe Y, Kondoh O, Sakamoto H. Alectinib shows potent antitumor activity against RET-rearranged non-small cell lung cancer. Mol Cancer Ther. 2014 Dec;13(12):2910-8. doi: 10.1158/1535-7163.MCT-14-0274. Epub 2014 Oct 27.
- Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Masters GA, Temin S, Azzoli CG, Giaccone G, Baker S Jr, Brahmer JR, Ellis PM, Gajra A, Rackear N, Schiller JH, Smith TJ, Strawn JR, Trent D, Johnson DH; American Society of Clinical Oncology Clinical Practice. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015 Oct 20;33(30):3488-515. doi: 10.1200/JCO.2015.62.1342. Epub 2015 Aug 31. Erratum In: J Clin Oncol. 2016 Apr 10;34(11):1287.
- Zbuk KM, Eng C. Cancer phenomics: RET and PTEN as illustrative models. Nat Rev Cancer. 2007 Jan;7(1):35-45. doi: 10.1038/nrc2037. Epub 2006 Dec 14.
- Grieco M, Santoro M, Berlingieri MT, Melillo RM, Donghi R, Bongarzone I, Pierotti MA, Della Porta G, Fusco A, Vecchio G. PTC is a novel rearranged form of the ret proto-oncogene and is frequently detected in vivo in human thyroid papillary carcinomas. Cell. 1990 Feb 23;60(4):557-63. doi: 10.1016/0092-8674(90)90659-3.
- Bongarzone I, Vigneri P, Mariani L, Collini P, Pilotti S, Pierotti MA. RET/NTRK1 rearrangements in thyroid gland tumors of the papillary carcinoma family: correlation with clinicopathological features. Clin Cancer Res. 1998 Jan;4(1):223-8.
- Wang R, Hu H, Pan Y, Li Y, Ye T, Li C, Luo X, Wang L, Li H, Zhang Y, Li F, Lu Y, Lu Q, Xu J, Garfield D, Shen L, Ji H, Pao W, Sun Y, Chen H. RET fusions define a unique molecular and clinicopathologic subtype of non-small-cell lung cancer. J Clin Oncol. 2012 Dec 10;30(35):4352-9. doi: 10.1200/JCO.2012.44.1477. Epub 2012 Nov 13.
- Kohno T, Ichikawa H, Totoki Y, Yasuda K, Hiramoto M, Nammo T, Sakamoto H, Tsuta K, Furuta K, Shimada Y, Iwakawa R, Ogiwara H, Oike T, Enari M, Schetter AJ, Okayama H, Haugen A, Skaug V, Chiku S, Yamanaka I, Arai Y, Watanabe S, Sekine I, Ogawa S, Harris CC, Tsuda H, Yoshida T, Yokota J, Shibata T. KIF5B-RET fusions in lung adenocarcinoma. Nat Med. 2012 Feb 12;18(3):375-7. doi: 10.1038/nm.2644.
- Lipson D, Capelletti M, Yelensky R, Otto G, Parker A, Jarosz M, Curran JA, Balasubramanian S, Bloom T, Brennan KW, Donahue A, Downing SR, Frampton GM, Garcia L, Juhn F, Mitchell KC, White E, White J, Zwirko Z, Peretz T, Nechushtan H, Soussan-Gutman L, Kim J, Sasaki H, Kim HR, Park SI, Ercan D, Sheehan CE, Ross JS, Cronin MT, Janne PA, Stephens PJ. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies. Nat Med. 2012 Feb 12;18(3):382-4. doi: 10.1038/nm.2673.
- Plaza-Menacho I, Mologni L, McDonald NQ. Mechanisms of RET signaling in cancer: current and future implications for targeted therapy. Cell Signal. 2014 Aug;26(8):1743-52. doi: 10.1016/j.cellsig.2014.03.032. Epub 2014 Apr 3.
- Drilon A, Wang L, Hasanovic A, Suehara Y, Lipson D, Stephens P, Ross J, Miller V, Ginsberg M, Zakowski MF, Kris MG, Ladanyi M, Rizvi N. Response to Cabozantinib in patients with RET fusion-positive lung adenocarcinomas. Cancer Discov. 2013 Jun;3(6):630-5. doi: 10.1158/2159-8290.CD-13-0035. Epub 2013 Mar 26.
- Michels S, Scheel AH, Scheffler M, Schultheis AM, Gautschi O, Aebersold F, Diebold J, Pall G, Rothschild S, Bubendorf L, Hartmann W, Heukamp L, Schildhaus HU, Fassunke J, Ihle MA, Kunstlinger H, Heydt C, Fischer R, Nogova L, Mattonet C, Hein R, Adams A, Gerigk U, Schulte W, Luders H, Grohe C, Graeven U, Muller-Naendrup C, Draube A, Kambartel KO, Kruger S, Schulze-Olden S, Serke M, Engel-Riedel W, Kaminsky B, Randerath W, Merkelbach-Bruse S, Buttner R, Wolf J. Clinicopathological Characteristics of RET Rearranged Lung Cancer in European Patients. J Thorac Oncol. 2016 Jan;11(1):122-7. doi: 10.1016/j.jtho.2015.09.016.
- Gautschi O, Zander T, Keller FA, Strobel K, Hirschmann A, Aebi S, Diebold J. A patient with lung adenocarcinoma and RET fusion treated with vandetanib. J Thorac Oncol. 2013 May;8(5):e43-4. doi: 10.1097/JTO.0b013e31828a4d07. No abstract available.
- Kurzrock R, Sherman SI, Ball DW, Forastiere AA, Cohen RB, Mehra R, Pfister DG, Cohen EE, Janisch L, Nauling F, Hong DS, Ng CS, Ye L, Gagel RF, Frye J, Muller T, Ratain MJ, Salgia R. Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol. 2011 Jul 1;29(19):2660-6. doi: 10.1200/JCO.2010.32.4145. Epub 2011 May 23.
- Vergote IB, Smith DC, Berger R, Kurzrock R, Vogelzang NJ, Sella A, Wheler J, Lee Y, Foster PG, Weitzman R, Buckanovich RJ. A phase 2 randomised discontinuation trial of cabozantinib in patients with ovarian carcinoma. Eur J Cancer. 2017 Sep;83:229-236. doi: 10.1016/j.ejca.2017.06.018. Epub 2017 Jul 26.
- Mukhopadhyay S, Pennell NA, Ali SM, Ross JS, Ma PC, Velcheti V. RET-rearranged lung adenocarcinomas with lymphangitic spread, psammoma bodies, and clinical responses to cabozantinib. J Thorac Oncol. 2014 Nov;9(11):1714-9. doi: 10.1097/JTO.0000000000000323.
- Drilon A, Rekhtman N, Arcila M, Wang L, Ni A, Albano M, Van Voorthuysen M, Somwar R, Smith RS, Montecalvo J, Plodkowski A, Ginsberg MS, Riely GJ, Rudin CM, Ladanyi M, Kris MG. Cabozantinib in patients with advanced RET-rearranged non-small-cell lung cancer: an open-label, single-centre, phase 2, single-arm trial. Lancet Oncol. 2016 Dec;17(12):1653-1660. doi: 10.1016/S1470-2045(16)30562-9. Epub 2016 Nov 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRETA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Cabozantinib 20 MG
-
Alfredo BerrutiRecruitingCarcinoma ProstateItaly
-
ExelixisActive, not recruitingMedullary Thyroid CancerAustralia, France, Israel, Spain, Russian Federation, Netherlands, Hungary, Korea, Republic of, Croatia, Italy, Canada, Poland, Romania, Sweden
-
Vanda PharmaceuticalsCompletedNon-24-Hour-Sleep-Wake Disorder
-
Eisai Co., Ltd.Completed
-
Istituto Clinico HumanitasRecruiting
-
Peking Union Medical College HospitalNot yet recruiting
-
PfizerCompleted
-
BayerCompletedPharmacokineticsGermany
-
Janssen Research & Development, LLCCompleted
-
Tourmaline Bio, Inc.RecruitingThyroid Eye DiseaseUnited States, Jordan