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A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Phase II Study of Apatinib Mesylate Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

NCT02775370•Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed adenoid cystic carcinoma
•2. 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.
•3. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
•4. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and was previously treated with chemotherapy
•5. 18 years or older
•6. Karnofsky score over 60
•7. 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.
•8. Adequate organ function
•9. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
•10. A patient who signed the informed consent prior to the participation of the study and who understands that he or she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria

•1. A patient with no measurable disease
•2. 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)
•3. A patient with previous active or passive immunotherapy
•4. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
•5. A pregnant or lactating patient
•6. 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)
•7. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
•8. 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.
•9. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
•10. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.
+3 more criteria

Locations (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 1, 2016

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2018

Last Updated

September 26, 2018

Enrollment

ACTUAL participants

Conditions

Adenoid Cystic Carcinoma

Interventions

Apatinib Mesylate

DRUG

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

NCT06891560

Adenoid Cystic Carcinoma

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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

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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 26, 2018Data 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.

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A Study of Apatinib in Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Inclusion Criteria

Exclusion Criteria

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

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

Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

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Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial