A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck (NCT02775370) | Clinical Trial Compass
UnknownPhase 2
A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
China68 participantsStarted 2016-05
Plain-language summary
This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically confirmed adenoid cystic carcinoma
✓. Recurrent/Metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
✓. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
✓. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and was previously treated with chemotherapy
✓. 18 years or older
✓. Karnofsky score over 60
✓. Previous treatment with chemotherapy, targeted agents, loco-regional therapy (e.g. chemoembolization) are permitted providing that toxicity has resolved to \< or = grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
✓. Adequate organ function
Exclusion criteria
✕. A patient with no measurable disease
✕. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry)
✕. A patient with previous active or passive immunotherapy
✕
What they're measuring
1
Progression-free survival(PFS)
Timeframe: 6 months
Trial details
NCT IDNCT02775370
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
✕. A pregnant or lactating patient
✕. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential)
✕. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
✕. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin and cervical carcinoma in situ.