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Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

A Phase II Study of Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

NCT02098538•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if regorafenib is a useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an experimental drug that has not yet been approved for use in adenoid cystic carcinoma. In this study, the patient will initially be treated with a dose of regorafenib that is lower than what the FDA approved for other cancers in an attempt to decrease the risk of side effects. It is possible that this lower starting dose may not be as effective as the higher FDA approved dose. If the patient does well with the lower dose for at least a month on treatment, the physician may consider increasing the dose to the FDA approved dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
•Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
•At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism). Any number of prior therapies for recurrent/metastatic ACC are allowed.
•Patients must have RECIST v1.1 measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
•Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within 6 months prior to study enrollment. Note: This assessment will be performed by the treating investigator. Evidence of progression by RECIST criteria is not required.
•Patients must have archival tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or twenty unstained slides are acceptable. If twenty slides are not available, a lesser amount may be acceptable after discussion with the Principal Investigator, Dr. Alan L. Ho.
•Patients must agree to undergo biopsy of a malignant lesion. Biopsies do not need to be done if either the investigator or person performing the biopsy judges that no tumor is accessible for biopsy or that biopsy poses too great of a risk to the patient. Patients may also be exempt if frozen tumor tissue has been collected within 12 months of study enrollment that the Principal Investigator deems is appropriate/sufficient for analysis on this protocol.
•Age ≥ 18 years.
•ECOG performance status ≤ 2 (Karnofsky ≥ 60%,).
•Life expectancy of at least 12 weeks (3 months) as determined by the investigator.
+10 more criteria

Exclusion Criteria

•Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment. Concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed.
•Palliative radiation to non-target lesions is also allowed.
•Prior use of regorafenib.
•Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v4.0\] on repeated measurement) despite optimal medical management.
•Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
•Concurrent use of strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole). or strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).
•Use of any herbal remedy (e.g. St. John's wort \[Hypericum perforatum\])
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
•Active or clinically significant cardiac disease including:
•Congestive heart failure - New York Heart Association (NYHA) \> Class II.
+22 more criteria

Locations (5)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

November 7, 2024

Completion Date

November 7, 2024

Last Updated

September 10, 2025

Enrollment

ACTUAL participants

Conditions

Adenoid Cystic Carcinoma

Interventions

Regorafenib

DRUG

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

NCT06891560

Adenoid Cystic Carcinoma

View study

RECRUITINGNA

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

NCT01473784

Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Mucoepidermoid Carcinoma of the Oral Cavity+49 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

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