Cabozantinib in Advanced Salivary Gland Cancer Patients

NCT03729297 | Terminated Phase 2 DMC

• 1 other identifier: MOHN14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.

Conditions

Salivary Gland Cancer

Keywords

salivary gland cancer; adenoid cystic carcinoma; salivary duct carcinoma; cabozantinib; progression free survival; overall survival; phase 2 clinical trial

Outcome Measures

Primary Outcomes (1)

• overall response rate

  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

  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

Secondary Outcomes (12)

• progression free survival

  every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses PFS until progressive disease

• overall survival

  Every OPD visit (starting with every 2 weeks, increasing to every 12 weeks after 1 year)

• duration of response

  every 8 weeks (first year of treatment) and every 12 weeks (second year of treatment) a CT/MRI scan will be made to asses duration of response until progressive disease

• clinical benefit rate

  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 clinical benefit rate until progressive disease

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  through study completion. At every visit AE's will be recorded. Scheduled visits will be planned 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92 and 104 weeks after start of treatment

Study Arms (1)

cabozantinib

EXPERIMENTAL

cabozantinib 60 mg tablets OD

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.

Also known as: cabometyx

cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Concurrent treatment with any other anti-cancer therapy.
• Concomitant anticoagulation. Low dose aspirin for cardioprotection and low dose LMWH are permitted.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Ipsen: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (2)

• Weijers 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 DERIVED

• van 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 DERIVED

MeSH Terms

Conditions

Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Carla ML van Herpen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 cohorts: * adenoid cystic carcinoma * salivary duct carcinoma * other subtypes of salivary gland cancer sample size: The Simon two-stage design will be used, The first stage consists of 9 patients per cohort ((1) SDC, (2) ACC) evaluable for response. If 0 responses out of the first 9 evaluable patients are observed, the study will be stopped. In any other situation, the study will be continued until 17 patients are evaluable for response per cohort. If ≤2 responses are observed the study will accept the null hypothesis. If \>2 responses are observed, the null hypothesis will be rejected. In the third cohort (other SGC) 9 patients will be included to evaluate the efficacy of cabozantinib in other subtypes of c-MET positive SGC. Because different subtypes are included in this cohort, these results are hypothesis forming but will not be used for statistical analysis. Therefore, this study cohort will be closed after the first stage with 9 patients.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: November 2, 2018
• Study Start: September 5, 2018
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2019
• Last Updated: March 12, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)