Nasopharyngeal CarcinomaPhase 2NCT03906058
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
A Phase 2 study testing Anlotinib in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2019to 30 Apr 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy proved nasopharyngeal carcinoma;
- stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Who cannot join
- allergic to anlotinib;
- female within gestation period or lactation;
- patients received drug of other clinical trial within 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Anlotinib
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate
disease control rate
Measured: 30 months
Secondary outcomes (4)
overall response rate
overall response rate
Measured: 30 months
progression-free survival
progression-free survival
Measured: 30 months
overall survival
overall survival
Measured: 30 months
duration of response
duration of response
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start29 Apr 2019
- Primary completion27 Feb 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906058
- Sponsor's protocol ID
- B2018-167
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2019
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang Y, Su N, Zou Q, Cao Y, Xia Y, Tang L, Tian X, Liu P, Cai Q. Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial. BMC Med. 2023 Nov 7;21(1):423. doi: 10.1186/s12916-023-03140-x.
PubMed 37936166
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy
- ClinicalTrials.gov ID
- NCT03906058
- Acronym / sponsor ID
- B2018-167
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biopsy proved nasopharyngeal carcinoma;
- stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Key exclusion criteria (3 listed)
- allergic to anlotinib;
- female within gestation period or lactation;
- patients received drug of other clinical trial within 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnlotinibAll patients enrolled in the study will accept anlotinib treatment as a palliative treatment . | Drug | Anlotinib |
Primary outcome
disease control rate
Time frame: 30 months
disease control rate
4 secondary outcomes
overall response rate
Time frame: 30 months
progression-free survival
Time frame: 30 months
overall survival
Time frame: 30 months
duration of response
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 37936166Fang Y, Su N, Zou Q, Cao Y, Xia Y, Tang L, Tian X, Liu P, Cai Q. Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial. BMC Med. 2023 Nov 7;21(1):423. doi: 10.1186/s12916-023-03140-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease control rate (time frame: 30 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 NCT03906058, which also lists 1 linked publication.
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 25 Oct 2023.