AzTrials
AzTrials

Gastrointestinal Stromal TumorsPhase 3NCT04409223

Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib

A Phase 3 study testing Famitinib capsules and Sunitinib Capsules in people with Gastrointestinal Stromal Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The study is being conducted to evaluate the efficacy and safety of famitinib in the treatment of advanced gastrointestinal stromal tumour patients after failure of imatinib compared to sunitinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors
What is being tested?
Famitinib capsules and Sunitinib Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
1 siteChina
Study dates
12 Sep 2020to 25 Mar 2022
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients were enrolled voluntarily and signed informed consent, with good compliance and follow-up
  • Age ≥18 years (on the date of signing informed consent), for both men and women
  • Histologically confirmed metastatic or untreatable gastrointestinal stromal tumors have at least one measurable lesion that meets the criteria of RECIST v1.1. Lesions that have undergone radiotherapy must be confirmed by imaging to show progression after radiotherapy
  • Previous treatment with imatinib and eventual treatment failure (disease progression or toxicity intolerance during treatment)
  • The subjects were able to provide 10 ml blood samples and fresh or archived tumor tissue, or to receive biopsy at baseline for biomarker analysis.
  • Note: if there is no archived tumor tissue sample, those at high risk of receiving biopsy after assessment by the researcher, who can provide the previous c-kit /PDGFRA test report, may also be selected for inclusion.
Show all 11Show fewer
  • Eastern Cooperative Oncology Group performance status of 1 or lower
  • Expected survival ≥12 weeks
  • Vital organs and body functions meet the following requirements (no blood products or cell agents are allowed to be used within 14 days before the first use):
  • Neutrophil absolute count ≥1.5×109/L; Platelet ≥ 100×109/L; Hemoglobin ≥ 90 g/L; Bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN serum creatinine≤1.5×ULN; Results of urinary protein <2+; If urinary protein is ≥2+, 24-hour quantitative determination of urinary protein should be conducted, and no more than 1g/24 hour is qualified. Serum calcium, potassium, magnesium and phosphorus are within the normal range or have been corrected to the normal range before randomization. International standardized ratio INR≤ 1.5 and activated partial thromboplastin time APTT≤1.5×ULN; QTc≤ 450 ms (male), 470 ms (female); Left ventricular ejection fraction LVEF≥50%.
  • Use of a medically approved contraceptive method (e.g., intrauterine contraceptive device, contraceptive pill or condom) during the study period and within 90 days after the end of the study period for female patients of non-surgical sterilization or childbearing age; The serum HCG of female patients of childbearing age without surgical sterilization must be negative within 72 hours before randomization, and must be non-lactating to be enrolled; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the study period and within 90 days after the end of the study period.

Who cannot join

  • Previously received molecular targeted therapy for gastrointestinal stromal tumor except imatinib
  • The toxicity of previous imatinib or other treatments has not recovered or reached NCI CTC AE 5.0≤ 1
  • For patients with clinical symptoms of ascites or pleural effusion, those requiring puncture drainage or those who had received thoracic or ascites drainage within 1 month before signing informed consent were excluded, those with only small amount of ascites or pleural effusion on imaging but no clinical symptoms are qualified.
  • A second primary malignancy occurred within the last 5 years, except for adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix
  • Gastrointestinal stromal tumor with central nervous system metastasis
  • Inability to swallow, chronic diarrhea, intestinal obstruction, or factors that affect drug use and absorption
Show all 17Show fewer
  • Bleeding≥ grade 2 occurred in the first 4 weeks of randomization (NCI, CTC, AE 5.0)
  • Symptoms occurred within 12 months before randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or an arteriovenous embolism event (e.g., deep venous embolism of lower extremities, pulmonary embolism) within 6 months
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as (1) heart failure above NYHA grade 2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
  • Have hypertension, and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥ 140mmhg or diastolic blood pressure ≥ 90mmhg, if the blood pressure was abnormal during the screening period, 2 consistent measurements must be done with an interval of more than 24h after medical correction); Previous hypertensive crisis or hypertensive encephalopathy;
  • Drug uncontrollable thyroid dysfunction
  • Known acute or chronic active hepatitis, HBV virus titer > 500 IU, HCV RNA detection > ULN
  • History of immunodeficiency, including HIV positive, acquired or congenital immunodeficiency disorder, or a history of organ transplantation
  • Major surgery or radiotherapy within the first 4 weeks of randomization, or temporary palliative radiotherapy for pain relief within the first 1 week of randomization; Molecular-targeted therapy (including oral targeted drugs in other clinical trials) is less than 5 drug half-lives away form randomization date
  • Participated in clinical trials of other drugs in the first 4 weeks of randomization
  • Digestive tract perforation occurred 3 months before randomization
  • In the judgment of the investigator, a concomitant illness (severe diabetes, a clear history of neurological or mental disorders, e.g., epilepsy or dementia) that seriously endangers the patient's safety or prevents the patient from completing the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • 307 Hospital of PLA

    Beijing

Other trials in China

About this study

Official title: A Phase III, Open Label, Randomised，Controlled, Multi-centre Study to Assess the Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib

The study is being conducted to evaluate the efficacy and safety of famitinib in the treatment of advanced gastrointestinal stromal tumour patients after failure of imatinib compared to sunitinib.

Being tested
Famitinib capsules, Sunitinib Capsules
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

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

  • Famitinib capsulesDrug

    Oral KIT/PDGFRA kinase inhibitor

  • Sunitinib CapsulesDrug

    Also called Sutent

    Oral receptor tyrosine kinase (RTK) inhibitor

Study groups in NCT04409223
Study groupRoleWhat they receive
FamitinibExperimentalNot described
Receives: Drug: Famitinib capsules
SunitinibActive comparatorNot described
Receives: Drug: Sunitinib Capsules

What is being measured

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

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) assessed by BIRC based on RECIST 1.1 criteria

    Measured: 30 months

Secondary outcomes (9)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) assessed by BIRC based on mRECIST criteria

    Measured: 30 months

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) assessed by researchers based on RECIST 1.1 criteria

    Measured: 30 months

  3. time to disease progression (TTP)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: time to disease progression (TTP)

    Measured: 30 months

  4. Time to treatment failure (TTF)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Time to treatment failure (TTF);

    Measured: 30 months

  5. Objective response rate (ORR)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Objective response rate (ORR)

    Measured: 30 months

  6. Duration of Response (DOR)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Duration of Response (DOR)

    Measured: 30 months

  7. Disease control rates (DCR)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Disease control rates (DCR)

    Measured: 30 months

  8. overall survival (OS)

    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: overall survival (OS)

    Measured: 30 months

  9. Adverse Events and Serious Adverse Events

    Adverse Events and Serious Adverse Events

    Measured: 30 months

Timeline

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

  1. First posted1 Jun 2020
  2. Study start12 Sep 2020
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

Why it stopped: R\&D strategy adjustment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04409223
Sponsor's protocol ID
SHR-1020-Ⅲ-303
Status last verified
Feb 2024
First submitted
27 May 2020
Last updated
9 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Famitinib capsules and Sunitinib Capsules in people with Gastrointestinal Stromal Tumors, run by Jiangsu HengRui Medicine Co., Ltd. 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Feb 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: R\&D strategy adjustment). 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: 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 NCT04409223.

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 9 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in