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

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Brief Title

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

Official Title

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

Brief 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival(PFS)

Secondary Outcome

 Overall survival rate

Condition

Adenoid Cystic Carcinoma

Intervention

Apatinib Mesylate

Study Arms / Comparison Groups

 Apatinib group
Description:  Apatinib Mesylate administered as a daily oral treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

68

Start Date

May 2016

Completion Date

December 2018

Primary Completion Date

December 2017

Eligibility Criteria

        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.

         11. Ongoing cardiac arrhythmia of grade > or = 2, atrial fibrillation of any grade, or QTc
             interval > 450 msec for males or > 470 msec for female.

         12. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs

         13. A patient with organ transplantation requiring immunosuppressive therapy
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Chenping Zhang, M.D., , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02775370

Organization ID

2016HNRT003


Responsible Party

Principal Investigator

Study Sponsor

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


Study Sponsor

Chenping Zhang, M.D., Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University


Verification Date

September 2018