Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01703455
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2012-04-06
Brief Title:
Activity of Sorafenib in Salivary Gland Cancer
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Sorafenib in Recurrent andor Metastatic Salivary Gland Carcinomas Phase II Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single agent prospective open-label monocenter phase II trial of sorafenib in patients with recurrent andor metastatic salivary gland carcinoma This trial will be conducted with the primary aim to determine the response rate CRPR according to the RECIST criteria Response rate according to CHOI criteria correlation between CHOI criteria and outcome disease Control Rate DCR and acute toxicity will be evaluated as secondary objectives
Detailed Description:
This phase II trial was conducted on adult patients with RMSGC Inclusion criteria were as follows histologically proven diagnosis of RMSGC availability of primary tissue block or formalin fixed paraffin embedded FFPE tissue slides age _18 years Eastern Cooperative Oncology Group Performance Status ECOG-PS 0e1 adequate bone marrow liver and renal function haemoglobin 90 gdl neutrophil count 1500mm3 platelet count _100000ml total bilirubin 15 _ upper limit of normal ULN ALT and AST 25 _ ULN and 5 _ ULN for patients with liver metastases serum creatinine 15 _ ULN alkaline phosphatase 4 _ ULN PT-INRPTT 15 _ ULN _1 measurable unidimensional lesion by magnetic resonance imaging MRI or computed tomography CT scan according to the RECIST 11 criteria Patients with cardiac disease ie congestive heart failure New York Heart Association NYHA 2 cardiac arrhythmia uncontrolled hypertension in the six months before study entry were excluded Previous chemotherapy for metastatic disease was allowed and progression of disease was not required for the enrolment All patients provided written informed consent The study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki and was approved by the local Ethical Committee Registry number NCT01703455 22 Treatment and assessments Patients received 400 mg of sorafenib orally every 12 h on a continuous basis in 4-week cycles until disease progression andor unacceptable toxicity Biochemical and clinical evaluation and drug safety monitoring according to the Common Terminology Criteria for Adverse Events CTCAE v30 were performed every 4 weeks The attribution of adverse events AEs to the study drug was judged by the investigators CT scans were performed every 8 weeks until disease progression An independent evaluation of radiological response RECIST and Choi criteria was performed by two radiologists on anonymised CT scans Stomatology evaluation was performed at baseline to exclude any sign of osteoradionecrosis Dose reduction was adopted in cases of clinically significant haematologic or other AEs that were considered related to sorafenib In such cases doses were reduced to 400 mg once daily and then to 400 mg every other day If further reductions were required patients were withdrawn from the trial Dose reescalation was not allowed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None