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Trial record 4 of 128 for:    Adenoid Cystic Carcinoma

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

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ClinicalTrials.gov Identifier: NCT02775370
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: Apatinib Mesylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arm Intervention/treatment
Experimental: Apatinib group
Apatinib Mesylate administered as a daily oral treatment
Drug: Apatinib Mesylate
Apatinib Mesylate will be administered orally at 500 mg once daily for 5 consecutive days, and this was followed by a 2-day rest every week; each cycle consisted of 28 days




Primary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 6 months ]
    To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma


Secondary Outcome Measures :
  1. Overall survival rate [ Time Frame: 2 years ]
    from date of enrollment until date of first death from any cause, assessed up to 2 years

  2. Response rate [ Time Frame: 8 weeks ]
    CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Response rate will be evaluated by RECIST criteria

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: through study completion, an average of 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775370


Locations
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China, Shanghai
Shanghai ninth people's hospital
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Principal Investigator: Chenping Zhang, M.D. Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Principal Investigator: Guopei Zhu, M.D. Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Responsible Party: Guopei Zhu, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02775370     History of Changes
Other Study ID Numbers: 2016HNRT003
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action