Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02860936
• Date of registration: 02/08/2016
• Prospective Registration: No
• Primary sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Public title: Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14 ACC-LEN14
• Scientific title: Phase II Study on Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands of the Upper Aerodigestive Tract
• Date of first enrolment: June 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02860936
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Lisa Licitra
• Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adenoid Cystic Carcinomas of the Salivary Glands

Intervention(s)

Drug: Lenvatinib

Primary Outcome(s)

Objective response rate (CR+PR) [Time Frame: 2 years and 5 months]

Secondary Outcome(s)

Progression free survival [Time Frame: 2 years and 5 months]

Safety and toxicity profile of lenvatinib (according to CTCAE v 4.0) [Time Frame: 2 years and 5 months]

Overall survival [Time Frame: 2 years and 5 months]

Duration of response [Time Frame: 2 years and 5 months]

Secondary ID(s)

INT 38/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors