Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma (NCT02780310)

🧪 Interventions in This Study

• Lenvatinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
2. Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
3. 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.
4. 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 non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
5. 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.
6. 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 less than twenty unstained slides are available, the patient may be able to participate at the discretion of the investigator.)
7. Age ≥ 18 years
8. ECOG performance status \<2 (Karnofsky \>60%)
9. Adequate bone marrow, liver and renal function (as suggested for lenvatinib studies).
10. Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
11. Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
12. Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York
• Memorial Sloan Kettering Westchester — Harrison, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Adenoid Cystic Carcinoma

• Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial — San Francisco, California
• A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma — Basking Ridge, New Jersey
• Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers — Miami, Florida
• CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC — Boston, Massachusetts
• Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma — San Francisco, California

Explore by condition: All Adenoid Cystic Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.