To assess the objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DoR), toxicity, and quality of life (QoL) of patients with advanced SGC treated with cabozantinib in 3 cohorts: salivary duct…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the objective response rate (ORR)
Secondary outcome
To assess the progression free survival (PFS), overall survival (OS), duration
of response (DoR), toxicity, and quality of life (QoL) of patients with
advanced SGC treated with cabozantinib in 3 cohorts: salivary duct carcinoma
(SDC), adenoid cystic carcinoma (ACC), other SGC*s.
Background summary
Salivary gland cancer (SGC) is a rare cancer with 24 histological subtypes.
Treatment options for locally advanced and/or metastatic SGC are limited. The
tyrosine kinase inhibitor cabozantinib suppresses tumor growth, angiogenesis,
and metastasis, and has been approved for renal cell carcinoma and thyroid
cancer. Cabozantinib may also be of value in advanced SGC because c-MET, one of
the targets of cabozantinib, is frequently overexpressed in SGC.
Study objective
To assess the objective response rate (ORR), progression free survival (PFS),
overall survival (OS), duration of response (DoR), toxicity, and quality of
life (QoL) of patients with advanced SGC treated with cabozantinib in 3
cohorts: salivary duct carcinoma (SDC), adenoid cystic carcinoma (ACC), other
SGC*s.
Study design
Single arm, single center, phase II clinical trial
Intervention
Cabozantinib tablets 60 mg once daily until progressive disease, intolerable
toxicity, or investigator and/or patient decision to withdraw for a maximum
duration of 2 years.
Study burden and risks
Burden and risks: Patients will use the study medication for a maximum duration
of 2 years. During these 2 years, patients will make 17 study related visits
with blood analysis, urine analysis and an ECG at every visit. 12 CT scans will
be made and patients will be asked to fill in questionnaires 7 times. The
safety of Cabometyx is well known because of studies in renal cell carcinoma.
Benefit: Because Cabometyx has not been tested in SGC patients before, the
chance of responding to treatment is unknown. The Simon 2-stage design will be
used to prevent exposure of too many patients to ineffective treatment without
discarding a potential effective treatment because of treatment failure in some
patients.
Group relatedness: The study does not involve minors and/or incapacitated
subjects.
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
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 < 2.5 x upper limit of normal (ULN), Total bilirubin * 1.5 x ULN (except for Gilbert*s syndrome),
serum albumine *28 g/L
- Renal function: Creatinine < 1.5 x ULN or calculated creatinine clearance * 40 ml/min,
Urine protein/creatinine ratio *113.1 mg/mmol (*1 mg/mg) or 24-hour urine protein <1 g
- Hemoglobin A1c (HbA1c) * 8% or a fasting serum glucose * 9 mmol/l
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-000682-36-NL |
| CCMO | NL65109.091.18 |