Phase II study on Inlyta® (axitinib) in recurrent and/or metastatic salivary gland cancers (SGCs) of the upper aerodigestive tract

Phase 1

Conditions: recurrent and/or metastatic salivary gland cancers of the upper aerodigestive tract
MedDRA version: 17.0Level: LLTClassification code 10051975Term: Salivary gland carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-003227-21-IT

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 26

Inclusion Criteria

-Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated
-Archival tissue samples from primary tumor or metastasis for translational biological research
-Subjects with at least one measurable target lesion by CT-scan or MRI according to RECIST criteria 1.1 (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). A previously treated lesion by radiotherapy can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
-Clinical or radiological progression of disease within 6 months at study entry ; progression of disease by RECIST is not required
-Age = 18 years
-ECOG Performance Status < 2
-Adequate bone marrow, liver and renal function
-Urinary protein < 2+ by urine dipstick. If dipstick is = 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is < 2 g per 24 hours
-No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure reading must be =140, and the baseline diastolic blood pressure readings must be < 90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

-Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
-Previous systemic therapy for metastatic disease is not allowed (chemotherapy or TKI)
-History of cardiac disease: congestive heart failure > NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
-Known allergic reaction to any of the components of the treatment
-Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
-Legal incapacity or limited legal capacity
-Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
-Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent
-Pregnant or breast-feeding patients.
-Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated < 3 years prior to study entry.
-Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
-History of organ allograft.
-Patients with evidence or history of bleeding diathesis
-Gastrointestinal abnormalities (i.e. inability to take oral medication; malabsorption syndrome)
-Requirement for anticoagulant therapy with oral vitamin K antagonists
-Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
-Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed)
-Major surgery within 2 weeks of start of study
-Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction; patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
-Investigational drug therapy outside of this trial during or within 4 weeks of study entry
-Current use or anticipated need for treatment with drugs inhibiting CYP3A4
-Current use or anticipated need for treatment with drugs inducing CYP3A4 or CYP1A2