Clinical trial · Interventional
Cabozantinib in Advanced Salivary Gland Cancer Patients
The Efficacy of Cabozantinib in Advanced SAlivary Gland Cancer Patients, a Phase II Clinical Trial
NCT03729297CI-TRIAL-00050625Cabo ASAPterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): safety issues
Summary
Brief summary (as posted)
Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cabozantinib
- description
- cabozantinib 60 mg tablets OD
- interventionNames
- Drug: Cabozantinib
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses the response rate until progressive disease
- description
- Response will be measured according to RECIST version 1.1, the overall response rate is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient
Secondary outcomes (12)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Disease specific * locally advanced, recurrent, and/or metastatic SGC (excluding sarcomas and mesenchymal tumors) * c-MET positive disease * 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 albumin ≥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
References
Publications (2)
- DERIVEDWeijers JAM, de Bitter TJJ, Verhaegh GW, van Boxtel W, Uijen MJM, van Engen-van Grunsven ACH, Driessen CML, Schalken JA, Ligtenberg MJL, van Herpen CML. Exploring the potential of circulating tumour DNA to monitor treatment response in salivary duct carcinoma patients of the CABO-ASAP trial. Oral Oncol. 2023 Dec;147:106620. doi: 10.1016/j.oraloncology.2023.106620. Epub 2023 Nov 6. No abstract available. PMID 37939426
- DERIVEDvan Boxtel W, Uijen MJM, Krens SD, Dijkema T, Willems SM, Jonker MA, Pegge SAH, van Engen-van Grunsven ACH, van Herpen CML. Excessive toxicity of cabozantinib in a phase II study in patients with recurrent and/or metastatic salivary gland cancer. Eur J Cancer. 2022 Jan;161:128-137. doi: 10.1016/j.ejca.2021.10.033. Epub 2021 Dec 14. PMID 34920917