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Adenoid Cystic CarcinomaPhase 2NCT02775370

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

A Phase 2 study testing Apatinib Mesylate in people with Adenoid Cystic Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
Apatinib Mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
May 2016to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
  • 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.

Who cannot join

  • 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
  • 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)
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  • 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.
  • 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.
  • 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.
  • Ongoing cardiac arrhythmia of grade > or = 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for female.
  • A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
  • A patient with organ transplantation requiring immunosuppressive therapy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai ninth people's hospital

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

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.

Being tested
Apatinib Mesylate
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apatinib MesylateDrug

    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

Study groups in NCT02775370
Study groupRoleWhat they receive
Apatinib groupExperimentalApatinib Mesylate administered as a daily oral treatment
Receives: Drug: Apatinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival(PFS)

    To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma

    Measured: 6 months

Secondary outcomes (3)

  1. Overall survival rate

    from date of enrollment until date of first death from any cause, assessed up to 2 years

    Measured: 2 years

  2. Response rate

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

    Measured: 8 weeks

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2017
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775370
Sponsor's protocol ID
2016HNRT003
Status last verified
Sep 2018
First submitted
12 May 2016
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Ye L, Zhang L, Li R, Pan X, Li J, Dou S, Jiang W, Wang C, Chen W, Zhu G. Combined all-trans retinoic acid with low-dose apatinib in treatment of recurrent/metastatic head and neck adenoid cystic carcinoma: A single-center, secondary analysis of a phase II study. Cancer Med. 2023 Apr;12(8):9144-9155. doi: 10.1002/cam4.5653. Epub 2023 Feb 3.

    PubMed 36734294

  • Zhu G, Zhang L, Dou S, Li R, Li J, Ye L, Jiang W, Dong M, Ruan M, Yang W, Zhang C. Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study. Ther Adv Med Oncol. 2021 May 8;13:17588359211013626. doi: 10.1177/17588359211013626. eCollection 2021.

    PubMed 33995600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Mesylate in people with Adenoid Cystic Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival(PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775370, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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