cabozantinib for salivary gland cancer patients

The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trial - Cabo ASAP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000682-36-NL

Enrollment

Registered

2018-05-16

Start date

2018-07-05

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Salivary gland cancer

Interventions

Trade Name: Cabometyx Product Name: Cabometyx Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: - Disease specific - locally advanced, recurrent, and/or metastatic SGC (excluding sarcomas and mesenchymal tumors) - c-MET positive disease (see paragraph 4.1) - Measurable disease per RECIST version 1.1 - Cohort-specific criteria ? - SDC cohort: Direct inclusion (no objective tumor growth prior to inclusion needed) ? - ACC cohort: Inclusion after objective growth in the last three months or complaints due to the disease ? - Other SGC’s: Inclusion after objective growth in the last three months or complaints due to the disease - General conditions - Age =18 years - Eastern Cooperative Oncology Group performance status of 0 or 1. - Normal number of neutrophils and thrombocytes - Liver function: ALT and AST =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - General conditions - A known allergy for cabozantinib or its components - Long QT-syndrome - Pregnancy or lactation - Patients (M/F) with reproductive potential not implementing adequate contraceptives measures - Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before inclusion - Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before inclusion and from minor surgery at least 10 days before inclusion - Uncontrolled illness including, but not limited to ? - Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias ? - Uncontrolled hypertension defined as sustained systolic BP > 150 mm Hg, or diastolic BP > 100 mm Hg ? - Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion ? - Serious active infections - Concomitant treatments - Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation. - Concurrent treatment with any other anti-cancer therapy. - Concomitant anticoagulation. ? - Low dose aspirin for cardioprotection and low dose LMWH are permitted. - Radiation therapy within the last 4 weeks before inclusion

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death. - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause. - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10 - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires. - Assess the response rate by using continuous tumor shrinkage end-points. - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted. ;Main Objective: Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. ;Primary end point(s): Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. ;Timepoint(s) of evaluation of this end point: in the first year of treatment, a evaluation CT will be made every 8 weeks, in the second year of treatment, an evaluation CT will be made every 12 weeks.	—

Measure

Time frame

Secondary Objective: - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death. - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause. - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10 - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires. - Assess the response rate by using continuous tumor shrinkage end-points. - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted. ;Main Objective: Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. ;Primary end point(s): Assess the overall response rate (ORR) of cabozantinib in advanced salivary gland cancer patients. ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient. ;Timepoint(s) of evaluation of this end point: in the first year of treatment, a evaluation CT will be made every 8 weeks, in the second year of treatment, an evaluation CT will be made every 12 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death. - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause. - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10 - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires. - Assess the response rate by using continuous tumor shrinkage end-points. - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted.;Timepoint(s) of evaluation of this end point: progression free surival and duration of response will be evaluated using CT-scans (as the primary outcome). overall survival and toxicity will be evaluated at every visit. quality of life quesionairres will be taken 7 times, blood for circulating tumor DNA first every 2 week, en thereafter at every CT.	—

Measure

Time frame

Secondary end point(s): - Assess the progression free survival (PFS). PFS will be defined as time from study enrollment until disease progression or death. - Assess the overall survival (OS). OS will be defined as time from study enrollment until date of death of any cause. - Asses the duration of response (DoR). DoR is defined as time from study enrollment until date of documented tumor progression or death - Assess the toxicity of cabozantinib. Toxicity will be scored according to NCI CTC common criteria v 4.0.10 - Assess the quality of life (QoL) of patients treated with cabozantinib using EORTC questionnaires. - Assess the response rate by using continuous tumor shrinkage end-points. - circulating tumor DNA will be assessed to evaluate whether response and disease progression can be predicted.;Timepoint(s) of evaluation of this end point: progression free surival and duration of response will be evaluated using CT-scans (as the primary outcome). overall survival and toxicity will be evaluated at every visit. quality of life quesionairres will be taken 7 times, blood for circulating tumor DNA first every 2 week, en thereafter at every CT.

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Countries

Netherlands

Contacts

Public ContactHettie Maters

Radboud university medical center

hettie.maters@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026