Cabozantinib-s-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma
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|ClinicalTrials.gov Identifier: NCT02243605|
Recruitment Status : Recruiting
First Posted : September 18, 2014
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Ewing Sarcoma Metastatic Osteosarcoma Recurrent Ewing Sarcoma Recurrent Osteosarcoma Stage III Osteosarcoma AJCC v7 Stage IV Osteosarcoma AJCC v7 Stage IVA Osteosarcoma AJCC v7 Stage IVB Osteosarcoma AJCC v7 Unresectable Ewing Sarcoma Unresectable Osteosarcoma||Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis||Phase 2|
I. To evaluate the antitumor activity of cabozantinib-s-malate (cabozantinib) for Ewing sarcomas, in terms of 6-month objectives response as per the Response Evaluation Criteria in Solid Tumors, Revised (RECIST version [v]1.1).
II. To evaluate the antitumor activity of cabozantinib for osteosarcoma, in terms of 6-month objective response (complete response, partial response) and 6-month non-progression (complete response, partial response and stable disease), as per RECIST v1.1.
I. 6-month objective response. (Ewing sarcoma only) II. Best overall response (as per the revised RECIST v1.1). (Ewing sarcoma and osteosarcoma) III. 1- and 2-year progression-free survival. (Ewing sarcoma and osteosarcoma) IV. 1- and 2-year overall survival. (Ewing sarcoma and osteosarcoma) V. Cabozantinib safety. (Ewing sarcoma and osteosarcoma) VI. To assess the ability of metabolic tumor response as measured by fludeoxyglucose (FDG)-positron emission tomography (PET) at the end of one cycle of treatment to predict progression-free survival (PFS). (Ewing sarcoma and osteosarcoma) VII. Translational research: to determine and compare tumor expression of MET, phosphorylated (phosphor)-MET and circulating levels of HGF, soluble MET (sMET), VEGF-A, and soluble VEGF receptor 2 (VEGFR2) (sVEGFR2) prior to and following administration of cabozantinib. (Ewing sarcoma and osteosarcoma)
Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of XL184 (Cabozantinib) in Treating Patients With Relapsed Osteosarcomas and Ewing Sarcomas|
|Actual Study Start Date :||December 19, 2014|
|Estimated Primary Completion Date :||June 30, 2019|
Experimental: Treatment (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
- Non-progression, defined as complete response (CR), partial response (PR), or stable disease (osteosarcoma) [ Time Frame: At 6 months ]
- Objective response, defined as CR or PR (osteosarcoma) [ Time Frame: At 6 months ]
- Objective response, defined as CR or PR (Ewing sarcoma) [ Time Frame: At 6 months ]
- Best overall response [ Time Frame: From the start of the treatment until disease progression/recurrence, assessed up to 2 years ]Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). Will be described using frequency, percentage, and 95% confidence interval (binomial law).
- PFS [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years ]Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). PFS will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. Multivariate analyses can also be carried out based on Cox's proportional risk method and after checking the risk proportionality hypothesis.
- Overall survival (OS) [ Time Frame: Time from start of treatment to the time of death, assessed up to 2 years ]Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). OS will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. Multivariate analyses can also be carried out based on Cox's proportional risk method and after checking the risk proportionality hypothesis.
- Incidence of adverse events, assessed using the CTCAE version 4 [ Time Frame: Up to 2 years ]Quantitative variables will be described using mean and standard errors if the normality assumption is satisfied, else other descriptive statistics (median, range, quartiles) will be used. Qualitative variables will be described using frequency, percentage, and 95% confidence interval.
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): NCT02243605
|Institut Bergonie Cancer Center||Recruiting|
|Bordeaux, France, 33076|
|Contact: Antoine Italiano firstname.lastname@example.org|
|Principal Investigator: Antoine Italiano|
|Centre Georges-Francois Leclerc||Recruiting|
|Dijon, France, 21079|
|Contact: Nicolas Isambert 33-3-80-73-75-06 email@example.com|
|Principal Investigator: Nicolas Isambert|
|Centre Oscar Lambert||Recruiting|
|Lille, France, 59020|
|Contact: Nicolas P. Penel 33-3-20-29-59-20 firstname.lastname@example.org|
|Principal Investigator: Nicolas P. Penel|
|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
|Contact: Jean-Yves Blay 33-4-78-78-28-28 email@example.com|
|Principal Investigator: Jean-Yves Blay|
|Hopital De La Timone||Recruiting|
|Marseille, France, 13385|
|Contact: Florence Duffaud 33-4-91-38-74-14 Florence.firstname.lastname@example.org|
|Principal Investigator: Florence Duffaud|
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06189|
|Contact: Antoine Thyss 33-4-92-03-14-97 email@example.com|
|Principal Investigator: Antoine Thyss|
|Institut Curie Paris||Recruiting|
|Paris, France, 75005|
|Contact: Sophie Piperno-Neumann 33-1-44-32-46-80 firstname.lastname@example.org|
|Principal Investigator: Sophie Piperno-Neumann|
|Institut de Cancerologie de l'Ouest-Rene Gauducheau||Recruiting|
|Saint Herblain, France, 44805|
|Contact: Emmanuelle Bompas 33-2-40-67-99-39 email@example.com|
|Principal Investigator: Emmanuelle Bompas|
|CHRU Strasbourg - Hospital Civil||Recruiting|
|Strasbourg, France, 67091|
|Contact: Natacha Entz-Werle 33-3-88-12-80-97 Natacha.firstname.lastname@example.org|
|Principal Investigator: Natacha Entz-Werle|
|Center Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Christine Chevreau 33-5-61-42-42-42 email@example.com|
|Principal Investigator: Christine Chevreau|
|Villejuif, France, 94805|
|Contact: Olivier Mir 33-1-42-11-43-16 firstname.lastname@example.org|
|Principal Investigator: Olivier Mir|
|Principal Investigator:||Antoine Italiano||Institut Bergonie Cancer Center|