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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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;
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  • 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
  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Guopei Zhu, M.D., +8621 6417 5590, antica@gmail.com

    Guopei Zhu, M.D.

    Recruiting

Other trials in China

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.

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.

  1. Objective Response Rate (ORR)

    Measured: up to 24 months

Secondary outcomes (3)
  1. Disease Control Rate (DCR)

    Measured: up to 24 months

  2. Progress free survival (PFS)

    Measured: up to 24 months

  3. 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.

  1. First posted2 Jun 2021
  2. Study start1 May 2021
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 Dec 2023 (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
27 participants (estimated)
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

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.

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