Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma (NCT02780310) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma
United States33 participantsStarted 2016-05-19
Plain-language summary
The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a phase II study. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size.
Lenvatinib 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 lenvatinib is a useful drug for treating patients with adenoid cystic carcinomas.
Who can participate
Age range18 Years
SexALL
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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 non-nodal 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 availab…