Nasopharyngeal CarcinomaPhase 2NCT03130270
Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma
A Phase 2 study testing Apatinib mesylate tablet in people with Nasopharyngeal Carcinoma, run by Guilin Medical University, China at 4 sites in China.
Trial summary
The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the… 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?
- Apatinib mesylate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2017to 8 Dec 2019
- 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
- Male and female patients aged ranging from 18 to 70 years old.
- Patients with newly histologically proven nasopharyngeal carcinoma (NPC).
- Local recurrent NPC patients after comprehensive treatment, including clinical examination found a clear local area residue: electronic nasopharyngoscope found clear residual or enlarged cervical lymph nodes.
- Distant metastatic NPC patients after comprehensive treatment, including liver B ultrasound, chest X-ray, bone scan or other clinicians consider appropriate tests such as CT, MRI or PET/CT found distant metastases.
- Comprehensive treatment of local recurrence or distant metastasis after line or second-line therapy found progressive disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
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- Patient who has the expected survival time more than 3 months.
- Adequate hematological function: hemoglobin >80 g/L (no transfusion within 14 days), neutrophil count > 1.5×109/L, platelet count 80×109/L.
- Adequate liver function (serum total bilirubin ≤ 1.5 mg/dL, serum transminase ≤ 2.5 times higher than upper limit).
- Adequate renal function (creatinine clearance ≥ 50 mL/min).
- Participants volunteered to participate in this study, signed informed consent, good compliance and cooperated with us to complete the follow-up.
Who cannot join
- Before treatment, MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
- Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
- Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); any unstable angina pectoris; with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
- Patient who has positive urine protein.
- Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
- Medical history of arteriovenous thrombosis event within the past year, such as cerebral vascular accident (including transient ischemic attack) and deep venous thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged that the patient had recovered, these patients should be except) and pulmonary embolism.
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- A healed wound for long time or incomplete fracture.
- Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction.
- For females: patients should be surgical sterilization or postmenopausal patients, or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment; serum or urine pregnancy test must be negative, and must be non lactating period within 7 days before study; for males: patients should be treated with surgical sterilization or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment.
- History of psychotropic substance abuse and can not be removed or psychiatric disorders.
- Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Guilin Medical University
Guilin, Guangxi, 541001
Nanxishan hospital
Guilin, Guangxi
National Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
About this study
Official title: Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.
Read the detailed description
In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Apatinib mesylate tablet
- Keywords
- nasopharyngeal carcinoma, disease-free survival, adverse reaction
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib mesylate tabletDrug
Also called No.
Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity.
Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib group | Experimental | Apatinib mesylate tablet：the starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). Receives: Drug: Apatinib mesylate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
To evaluate ORR every 6-8 weeks after initiation of apatinib.
Measured: up to 24 months
Secondary outcomes (3)
Disease-free survival (DFS)
The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.
Measured: up to 24 months
Overall survival (OS)
The time from the first day of therapy to death or last follow-up.
Measured: up to 24 months
Toxicity evaluation
Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jan 2017
- Primary completion8 Apr 2019 (estimated)
- Study completion8 Dec 2019 (estimated)
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.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guilin Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Principal investigator, Wei Jiang, Guilin Medical University, China
- Investigators
- Wei Jiang, Principal investigator, Guilin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130270
- Sponsor's protocol ID
- GLMU-02
- Status last verified
- May 2018
- First submitted
- 21 Apr 2017
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruan X, Liang JH, Pan Y, Cai R, Zhang RJ, He Z, Yang X, Niu Z, Jiang W. Apatinib for the treatment of metastatic or locoregionally recurrent nasopharyngeal carcinoma after failure of chemotherapy: A multicenter, single-arm, prospective phase 2 study. Cancer. 2021 Sep 1;127(17):3163-3171. doi: 10.1002/cncr.33626. Epub 2021 May 27.
PubMed 34043812
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03130270
- Acronym / sponsor ID
- GLMU-02
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, disease-free survival, adverse reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Guilin Medical University, ChinaUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 8 Apr 2019 (estimated)
- Study completion
- 8 Dec 2019 (estimated)
- First posted
- 26 Apr 2017 (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 study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.
Detailed description
In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib group | Experimental | Drug: Apatinib mesylate tabletApatinib mesylate tablet：the starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female patients aged ranging from 18 to 70 years old.
- Patients with newly histologically proven nasopharyngeal carcinoma (NPC).
- Local recurrent NPC patients after comprehensive treatment, including clinical examination found a clear local area residue: electronic nasopharyngoscope found clear residual or enlarged cervical lymph nodes.
- Distant metastatic NPC patients after comprehensive treatment, including liver B ultrasound, chest X-ray, bone scan or other clinicians consider appropriate tests such as CT, MRI or PET/CT found distant metastases.
- Comprehensive treatment of local recurrence or distant metastasis after line or second-line therapy found progressive disease.
Key exclusion criteria (12 listed)
- Before treatment, MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
- Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
- Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); any unstable angina pectoris; with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
- Patient who has positive urine protein.
- Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
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 |
|---|---|---|
| Apatinib mesylate tabletAlso: No.Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity. Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment. | Drug | Apatinib group |
Primary outcome
Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
Time frame: up to 24 months
To evaluate ORR every 6-8 weeks after initiation of apatinib.
3 secondary outcomes
Disease-free survival (DFS)
Time frame: up to 24 months
Overall survival (OS)
Time frame: up to 24 months
Toxicity evaluation
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 34043812Ruan X, Liang JH, Pan Y, Cai R, Zhang RJ, He Z, Yang X, Niu Z, Jiang W. Apatinib for the treatment of metastatic or locoregionally recurrent nasopharyngeal carcinoma after failure of chemotherapy: A multicenter, single-arm, prospective phase 2 study. Cancer. 2021 Sep 1;127(17):3163-3171. doi: 10.1002/cncr.33626. Epub 2021 May 27.
- Individual participant dataSharing planned: No
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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.
Wei Jiang principal investigator
Guilin Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib mesylate tablet in people with Nasopharyngeal Carcinoma, run by Guilin Medical University, China at 4 sites 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 11 inclusion and 12 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma (time frame: up to 24 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 NCT03130270, 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 16 May 2018.