Head and Neck Cancers - Salivary GlandPhase 2NCT04910854
Surufatinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
A Phase 2 study testing Surufatinib in people with Head and Neck Cancers - Salivary Gland, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is a non-randomized, phase II, open label study of Surufatinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancers - Salivary Gland
- What is being tested?
- Surufatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2023
- 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
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed that recurrent or metastatic adenocarcinomas of the head and neck;
- Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or refusing surgical treatment;
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
Show all 14Show fewer
- Predicted survival ≥6 months;
- Screening laboratory values must meet the following criteria (within past 14 days):
- neutrophils ≥1.5×109/L ;
- platelets ≥9g/dL;
- hemoglobin ≥ 9.0 g/dL;
- albumin≥3g/dL;
- total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5╳ULN;
- Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
Who cannot join
- 1. Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months; 2. Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological immunotherapy,targeted therapy within 4 weeks.
- 3. Prior participation in other clinical trials not approved or listed in China within past 4 weeks; 4. Prior major surgery within past 4 weeks (diagnostic surgery excluded); 5. International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN; 6. Clinically significant severe electrolyte abnormality judged by investigator ; 7. Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg; 8. Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L); 9. The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally; 10. Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation; 11. Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month; 12. Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ,Coronary Artery Bypass Grafting within past 6 months,); 13. Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled); 14. Active or uncontrolled severe infection (≥CTCAE2 infection); 15. Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml); 16. Evidence with active CNS disease or previous brain metastases; 17. The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin; 18. Pregnant or nursing; 19. Transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF), had been received within 14 days before enrollment; 20. Tumor involving skin and/or pharyngeal mucosa with ulceration; 21. Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; 22. Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to doubt is not suitable for the use of study drugs in patients with a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or make the patients at high risk.
- 23. Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g; 24. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guopei Zhu, M.D., +8621 6417 5590, antica@gmail.com
Guopei Zhu, M.D.
About this study
Official title: A Study of Surufatinib in the Treatment of Recurrent/Metastatic Adenocarcinomas of the Head and Neck
This is a non-randomized, phase II, open label study of Surufatinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
- Conditions
- Head and Neck Cancers - Salivary Gland
- Being tested
- Surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), The curative effect was evaluated every 8 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: up to 24 months
Secondary outcomes (3)
Disease Control Rate (DCR)
Measured: up to 24 months
Progress free survival (PFS)
Measured: up to 24 months
Overall Survival (OS)
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 posted2 Jun 2021
- Study start1 May 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancers - Salivary GlandStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910854
- Sponsor's protocol ID
- 2021HNRT02
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Surufatinib in the Treatment of Recurrent/Metastatic Adenocarcinomas of the Head and Neck
- ClinicalTrials.gov ID
- NCT04910854
- Acronym / sponsor ID
- 2021HNRT02
- Conditions
- Head and Neck Cancers - Salivary Gland
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jun 2021 (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.
This is a non-randomized, phase II, open label study of Surufatinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed that recurrent or metastatic adenocarcinomas of the head and neck;
- Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or refusing surgical treatment;
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
Key exclusion criteria (3 listed)
- 1. Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months; 2. Prior antitumor therapy with chemotherapy, radical radiation therapy ,biological immunotherapy,targeted therapy within 4 weeks.
- 3. Prior participation in other clinical trials not approved or listed in China within past 4 weeks; 4. Prior major surgery within past 4 weeks (diagnostic surgery excluded); 5. International standardized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN; 6. Clinically significant severe electrolyte abnormality judged by investigator ; 7. Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg; 8. Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L); 9. The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally; 10. Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation; 11. Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month; 12. Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ,Coronary Artery Bypass Grafting within past 6 months,); 13. Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled); 14. Active or uncontrolled severe infection (≥CTCAE2 infection); 15. Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>2000IU/ml); 16. Evidence with active CNS disease or previous brain metastases; 17. The toxicity associated with previous anti-tumor treatment has not recovered to ≤CTCAE1, except for peripheral neurotoxicity and alopecia ≤CTCAE2 caused by oxaliplatin; 18. Pregnant or nursing; 19. Transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony stimulating factor (G-CSF), had been received within 14 days before enrollment; 20. Tumor involving skin and/or pharyngeal mucosa with ulceration; 21. Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; 22. Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to doubt is not suitable for the use of study drugs in patients with a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or make the patients at high risk.
- 23. Routine urine indicated that urine protein ≥2+, and the 24-hour urine protein volume >1.0g; 24. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
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 |
|---|---|---|
| SurufatinibPatients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), The curative effect was evaluated every 8 weeks. | Drug | – |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 24 months
Progress free survival (PFS)
Time frame: up to 24 months
Overall Survival (OS)
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 2 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancers - Salivary Gland
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
Salivary Gland Neoplasms
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.
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 Surufatinib in people with Head and Neck Cancers - Salivary Gland, 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 14 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (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?
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 2 Jun 2021.