Phase II study on Lenvatinib in recurrent and/or metastatic adenoid cystic carcinomas (ACC) of the salivary glands of the upper aerodigestive tract
- Conditions
- metastatic adenoid cystic carcinomas (ACC) of the salivary glands of the upper aerodigestive tractMedDRA version: 21.1Level: LLTClassification code 10026121Term: Malignant neoplasm of major salivary glands recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000693-35-IT
- Lead Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 26
1.Histologically proven relapsed and/or metastatic adenoid cystic carcinoma for which potentially curative options such as surgery or radiotherapy are not indicated.
2.Archival tissue samples or unstained 20 slides from primary tumor or metastasis for translational biological research.
3.Subjects with at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria 1.1 (target lesion). A previously treated lesion by radiotherapy or loco-regional therapies such as radiofrequency (RF) can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
4.Clinical or radiological progression of disease within 6 months at study entry. Progression of disease by RECIST is not required.
5.Age = 18 years
6.ECOG Performance Status < 2
7.Life expectancy of > 3 months
8.Adequately controlled blood pressure with or without antihypertensive medications, defined as BP < 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to Cycle 1 Day 1
9.Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
¿Hemoglobin >9.0 g/dl
¿Neutrophil count (ANC) >1,000/mm3
¿Platelet count ¿75,000/µl
¿Total bilirubin <1.5 times the upper limit of normal
¿ALT and AST <2.5 x upper limit of normal (<5 x upper limit of normal for patients with liver metastases)
¿Serum creatinine <1.5 x upper limit of normal
¿Alkaline phosphatase <4 x ULN
¿PT-INR/PTT <1.5 x upper limit of normal (Patients who are being therapeutically anticoagulated with an agent such as heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
10.Previous systemic therapy for metastatic disease is allowed for a maximum of 1 previous line of chemotherapy and/or 1 previous line of TKI
11.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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.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
2.Subjects having > 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein = 1 g/24h will be ineligible
3.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)
4.Gastrointestinal abnormalities (i.e. inability to take oral medication; malabsorption syndrome)
5.Requirement for anticoagulant therapy with oral vitamin K antagonists (LMWH therapy is accepted)
6.Prolongation of QTc interval to > 480 msec
7.Known allergic reaction to any of the components of the treatment
8.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
9.Legal incapacity or limited legal capacity
10.Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
11.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
12.Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial
13.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.
14.Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
15.History of organ allograft.
16.Patients with evidence or history of bleeding diathesis
17.Patients undergoing renal dialysis
18.Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
19.Previous therapy with lenvatinib (E7080)
20.Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed)
21.Major surgery within 2 weeks of start of study
22.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]
23.Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Response Rate according to RECIST criteria 1.1. ;Timepoint(s) of evaluation of this end point: two months;Main Objective: Response Rate according to RECIST criteria 1.1. ;Secondary Objective: ¿Progression free survival<br>¿Overall survival<br>¿Duration of response<br>¿Acute toxicity according to CTCAE v4.0<br>¿PRO Questionnaire: Quality of life (EORTC QLQ C-30, EORTC QLQ-H&N35, EQ-5D)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ¿Progression free survival<br>¿Overall survival<br>¿Duration of response<br>¿Acute toxicity according to CTCAE v4.0<br>¿PRO Questionnaire: Quality of life (EORTC QLQ C-30, EORTC QLQ-H&N35, EQ-5D)<br>;Timepoint(s) of evaluation of this end point: four years