Salivary gland cancer Trials in Disease

Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

This trial is testing BAY 2927088, an oral medication taken as a coated tablet, for patients with advanced solid tumors including salivary gland cancer. The medication is a reversible tyrosine kinase inhibitor that works by blocking certain proteins that help cancer cells grow.

Who can participate: Patients must be at least 18 years old with advanced solid tumors that cannot be removed by surgery. The cancer must have a specific genetic change called an activating HER2 mutation. Participants should have already tried standard treatments for their type and stage of cancer, or have no other satisfactory treatment options available. At least one tumor area must be measurable according to medical guidelines called RECIST 1.1 criteria.

Who cannot participate: Patients without a HER2 mutation, those with certain medical conditions that could interfere with the study, pregnant or breastfeeding women, and those who have recently participated in another clinical trial may not be eligible. Patients with allergies to the study medication also cannot participate.

What the trial aims to learn: The main goal is to understand how well BAY 2927088 works in reducing tumor size or stopping tumor growth. Researchers will monitor participants regularly to see how their tumors respond to treatment and check for any side effects. The study will also evaluate how long the treatment keeps the disease under control and how it affects overall health and quality of life. The trial is expected to continue until October 2027.

Study on the Effectiveness of Dutasteride with Goserelin Acetate and Bicalutamide in Patients with Recurrent or Metastatic Salivary Duct Carcinoma

This trial is investigating whether adding dutasteride to a standard hormone-blocking therapy can improve treatment outcomes for patients with salivary duct carcinoma that has returned or spread to other parts of the body. The study uses a combination of medications that block male hormones, which can help slow cancer growth.

Who can participate: Patients must be 18 years or older with a confirmed diagnosis of salivary duct carcinoma that cannot be cured. The cancer must be AR positive, meaning there is a strong presence of androgen receptors in at least 1% of cancer cells. Participants must have measurable disease according to medical guidelines and adequate heart, bone marrow, liver, and kidney function. They must have an ECOG performance status of 0 or 1, meaning they are fully active or have some symptoms but can still carry out light work.

Who cannot participate: Patients without salivary duct carcinoma, those under 18 years old, and individuals in vulnerable populations who cannot give proper consent are excluded.

What the trial aims to learn: The study will compare outcomes between patients receiving the combination treatment of goserelin acetate, bicalutamide, and dutasteride versus those receiving only goserelin acetate and bicalutamide. Some participants will receive a placebo instead of dutasteride to help researchers better understand the treatment's effects. The trial will monitor how well the combination works, measure the duration of response, track side effects, and assess quality of life. Treatment will continue for up to 12 months with regular check-ups.

Investigational medications: Goserelin acetate is given as an implant under the skin every 12 weeks. Bicalutamide is taken as a 50 mg tablet once daily. Dutasteride is taken as a 0.5 mg capsule once daily. These medications work by blocking hormones that can help certain cancer cells grow.

Study of Capecitabine for Patients with Recurrent or Metastatic Salivary Duct Carcinoma

This trial is studying capecitabine, an oral chemotherapy medication, for patients with salivary duct carcinoma that has either returned or spread to other parts of the body. The medication works by interfering with the growth of cancer cells and slowing their spread.

Who can participate: Patients must be 18 years or older with a confirmed diagnosis of salivary duct carcinoma that cannot be cured. The disease must be measurable according to RECIST guidelines or present as bone metastases. Participants must have adequate kidney, liver, and bone marrow function. If the cancer is AR+ HER2-, patients must have shown disease progression despite treatment with androgen blockade or be unwilling to receive it. If the cancer is AR+ HER2+, patients must have progressed despite anti-HER2 therapy and androgen blockade. All participants must have shown progression after carboplatin-paclitaxel treatment or be unable to receive it. An ECOG performance status of 0-1 is required.

Who cannot participate: Patients with a different type of cancer, those outside the specified age range, and individuals in vulnerable populations are excluded.

What the trial aims to learn: The primary goal is to evaluate the overall response rate to capecitabine in treating this type of cancer. Researchers will also assess how long patients can live without disease progression, overall survival rates, and the safety profile of the medication. The study will monitor clinical benefits, disease control, and quality of life throughout participation. The trial is expected to continue until the end of 2029.

Study on Sentinel Lymph Node Biopsy for Parotid Gland Cancer Using Gallium (68Ga) Chloride and Tilmanocept in Patients Undergoing Parotidectomy and Neck Dissection

This trial is exploring an advanced imaging technique to identify lymph nodes that may be affected by cancer in patients with parotid gland carcinoma. The procedure uses sentinel lymph node biopsy with special imaging agents to help surgeons locate the most important lymph nodes during surgery.

Who can participate: Patients must be 18 years or older with a diagnosis of primary carcinoma of the parotid gland staged between T1 and T4, cN0, M0. This means the cancer is at various sizes but has not spread to lymph nodes or other body parts based on imaging tests like CT, MRI, PET/CT, or ultrasound-guided fine needle aspiration conducted within 30 days before the procedure. Participants must be candidates for parotidectomy and elective neck dissection surgeries. An ECOG status of Grade 0 to 2 is required, meaning patients can range from being fully active to able to do self-care but unable to work.

Who cannot participate: Patients not scheduled for parotidectomy or elective neck dissection, those without parotid gland carcinoma, individuals under 18 or over 65 years old, and those in vulnerable populations are excluded.

What the trial aims to learn: The study aims to determine if the combination of 99mTc-nanocolloid and 68Ga-tilmanocept can successfully identify sentinel lymph nodes in at least 8 out of 10 patients using PET/CT imaging. These imaging agents help doctors visualize lymph nodes that are most likely to contain cancer cells. The study will compare results from the lymph node biopsy with findings from neck dissection surgery to check for cancer spread. Researchers will also assess the optimal timing for PET/CT imaging and monitor for any surgical complications. The findings could improve how doctors identify and treat affected lymph nodes in patients with this type of cancer.

Investigational imaging agents: 99mTc-nanocolloid is a radioactive tracer that helps identify sentinel lymph nodes on imaging scans. 68Ga-tilmanocept binds to specific receptors on certain cells, making it easier to visualize lymph nodes during PET/CT scans. Both agents are injected around the tumor area to help locate the first lymph nodes where cancer might spread.

Summary

These four clinical trials represent different approaches to advancing treatment and diagnosis for salivary gland cancers. The Netherlands hosts three of the four trials, demonstrating a particular concentration of research activity in that country. Denmark, France, Italy, and Spain are collaborating on one multinational trial.

The trials include various treatment strategies: targeted therapy with BAY 2927088 for HER2-mutated tumors, hormone-blocking therapy combinations with dutasteride, chemotherapy with capecitabine, and improved surgical planning through advanced imaging techniques. Each trial focuses on different aspects of the disease, from recurrent and metastatic salivary duct carcinoma to early-stage parotid gland cancer requiring surgical intervention.

Patients interested in participating should discuss these options with their healthcare providers to determine eligibility and whether participation might be appropriate for their specific situation. Each trial has specific requirements regarding cancer type, stage, previous treatments, and overall health status.