2026-525733-24-00RecruitingPhase 2
Valproic acid and lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia5 sites in 1 country15 target enrollmentStarted: August 15, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 15
- Locations
- 5
- Primary Endpoint
- Change in quality of life according to EORTC QoL Q30 – HN43/ EORTC QLQ-C30
Study Overview
Brief Summary
- To describe the impact on quality of life of VPA in in addition to lenvatinib
- To describe the response rate of VPA in in addition to lenvatinib
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological confirmed adenoid cystic carcinoma.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •For a woman of childbearing potential, a negative pregnancy test on plasma must also be confirmed within 3 days of the first dose of study treatment. Sexually active women of childbearing potential must agree to use a highly effective contraception methods, while on study and for 180 days after the last dose of study drug
- •Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: refrain from donating sperm, plus must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak)
- •Signature of Informed Consent.
- •Locally advanced and/or metastatic disease not amenable for curative treatment (neither surgery nor radiotherapy).
- •Locoregional recurrent ACC not amenable to curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to re- irradiate for any reason) with a history of clinical or symptomatic disease progression within 6 months.
- •Metastatic ACC (distant spread) not amenable to surgical therapy or radiotherapy and with a history of clinical or symptomatic disease progression within 6 months.
- •Patients must have clinically and/or radiographically documented measurable disease. At least one site of disease must be uni dimensionally measurable as per RECIST 1.
- •All radiology studies must be performed within 28 days prior to registration.
- •Patients Age ≥ 18 years old.
- •Life expectancy > 3 months.
- •Adequate hematologic and organ functions (Absolute Neutrophil Count > 1500/mm^3; Platelet Count > 100000/mm^3; Hemoglobin > 9 mg/dl; Creatinine Clearance > 60 ml/min as determined by 24-hour collection or estimated by the Cockroft Gault formula; Serum Bilirubin < 2 upper limit of normal; Aspartate Aminotransferase and Alanine Aminotransferase <2.5 x ULN or < 5 in patients with known liver metastases, urinary protein <1 g/24 h).
Exclusion Criteria
- •Patients with a documented severe allergy or anaphylactic reactions or hypersensitivity to the treatment proposed.
- •Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy
- •Medical conditions that might interfere with study treatment.
- •Women must not be pregnant or breastfeeding or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.; pregnant women are excluded from this study.
- •Patients with acute hepatitis, chronic hepatitis, hepatic porphyria or coagulation disorders.
- •Patients with long QTsyndrome, or QTc interval duration >480 msec.
- •Patients with significant cardiovascular failure: history of congestive heart failure greater than New Class II York Heart Association (NYHA), unstable angina, heart attack myocardium or cerebral vascular event within six months of the start of the study treatment or cardiac arrhythmia associated with unstable hemodynamics.
- •Patients with active hemoptysis or thrombotic or hemorrhagic within three weeks prior to the start of the treatment.
- •Patients with active infection (any infection that requires a treatment).
- •Patients with mitochondrial disorders or with known urea cycle disorders or with uncorrected systemic primitive carnitine deficiency.
- •Patients previously treated with lenvatinib or on treatment with VPA.
- •Patients with uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases.
Outcomes
Primary Outcomes
Change in quality of life according to EORTC QoL Q30 – HN43/ EORTC QLQ-C30
Change in quality of life according to EORTC QoL Q30 – HN43/ EORTC QLQ-C30
Overall response rate assessed according to RECIST 1.1
Overall response rate assessed according to RECIST 1.1
Secondary Outcomes
No secondary outcomes reported
Investigators
S.C. Clinical Trial Center
Scientific
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Study Sites (5)
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