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Soft Tissue SarcomaPhase 2NCT05142631

Fruquintinib in the Treatment of Soft Tissue Sarcoma

A Phase 2 study testing Fruquintinib in people with Soft Tissue Sarcoma, run by Fudan 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy of Fruquintinib in patients with chemotherapy insensitive or chemotherapy resistant soft tissue sarcoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Fruquintinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
21 Nov 2021to 30 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Only those who meet all of the following criteria can be selected:
  • Fully understand this study and voluntarily sign the informed consent form;
  • Male or female subjects / patients aged ≥ 18 years;
  • Non operative desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma and angiosarcoma with failed chemotherapy confirmed by histopathology;
  • Patients with desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or angiosarcoma who failed to receive anti angiogenesis drugs in the past.
  • At least one measurable lesion meeting the requirements of RECIST version 1.1; If the focus that has previously received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only focus, there must be a clear imaging basis for the disease progression of the focus;
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  • The ECoG score was 0 or 1;
  • The laboratory test results within 7 days before the first acceptance of the study drug must meet the following criteria:
  • 1) Neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 90 g / L (no blood transfusion, no blood products, no granulocyte colony stimulating factor or other hematopoietic stimulating factors within 7 days before laboratory examination);
  • 2) Total serum bilirubin ≤ 1.5 × Upper normal value (ULN);
  • 3) In the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN； ALT and AST ≤ 3 in patients with liver metastasis or liver cancer × ULN；［ Asymptomatic mild and moderate liver injury (defined as NCI CTCAE grade 1 toxicity) and elevated ALT and AST > 5 ~ 20 × Patients with ULN (NCI CTCAE Level 3) may tolerate the same dose of study drugs as patients with normal liver function. Patients with mild to moderate liver injury can be included on the premise that non clinical and clinical data (including pharmacokinetic and pharmacokinetic results) suggest that there is no unreasonable risk. If it is necessary to include patients with severe liver injury, it is necessary to discuss with the regulatory authority]
  • 4) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 ml / min (calculated according to Cockcroft Gault formula);
  • 5) Urine routine examination showed that urinary protein was < 2 +; If urinary protein ≥ 2 +, 24-hour urinary protein quantification should be < 1 g;
  • 6) International normalized ratio (INR) ≤ 1.5 and partially activated prothrombin time (APTT) ≤ 1.5 × ULN。
  • 8. Expected survival ≥ 12 weeks;
  • 9. Agree to abide by the regulations on smoking, drinking, diet and exercise restrictions during the study (which may cause more protocol violations, which shall be set according to the needs of the study);
  • 10. Female subjects / patients of childbearing age or male subjects / patients whose partners are women of childbearing age shall take effective contraceptive measures, such as double barrier contraceptive methods, condoms, intrauterine devices, abstinence, etc., from at least 1 month before receiving the study drug for the first time to 6 months after receiving the study drug for the last time.

Who cannot join

  • Those who meet any of the following exclusion criteria must be excluded from the study:
  • The toxicity of previous anti-tumor treatment has not recovered ≤ grade 1 (except hair loss, skin pigment change or neurotoxicity ≤ grade 2);
  • Other malignant tumors in the past 5 years (except skin basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ that have been effectively controlled); (according to FDA guideline 1, patients with the same or different tumor types who have been or are currently complicated with the same or different tumor types, whose medical history or treatment has no potential impact on the safety or efficacy evaluation of the study drug, should be included in the clinical study. For example, patients with previous or current malignant tumors should not be excluded in dose exploration, preliminary efficacy evaluation or proof of concept study)
  • There was central nervous system (CNS) metastasis in the past or screening, but the primary central solitary fibrous tumor can be included in the group;
  • Have received approved systemic anti-tumor therapy within 4 weeks before receiving the study drug for the first time, including chemotherapy (chemotherapy, biotherapy, targeted therapy (the washout period of small molecule targeted drugs is 2 weeks or 5 half lives, whichever is shorter), hormone therapy and traditional Chinese medicine therapy (for traditional Chinese medicine therapy with clear anti-tumor indications in the instructions, it can be treated after 1 week washout period before the first medication) Etc;
  • Radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks before receiving the study drug for the first time; brachytherapy (such as implantation of radioactive particles) within 60 days before receiving the study drug for the first time; palliative radiotherapy for bone metastases within 1 week before receiving the study drug for the first time;
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  • Major surgery (the definition of major surgery refers to grade 3 and 4 operations specified in the measures for the administration of clinical application of medical technology implemented on May 1, 2009) or unhealed wounds, ulcers and fractures within 4 weeks before receiving the study drug for the first time;
  • Prohibited combination drugs were used within 1 week before the first acceptance of the study drug or within 5 drug half-life (whichever is longer)
  • Within the first 4 weeks of the first study, any live vaccine or attenuated vaccine will be inoculated during the study period.
  • Previously received anti-angiogenic TKI drugs;
  • At present, there is uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as that it cannot be effectively controlled by diuretics or puncture according to the judgment of the researcher);
  • Gastrointestinal diseases such as gastric and duodenal active ulcer and ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researcher before the study;
  • Patients with evidence or history of thrombosis or obvious bleeding tendency within 2 months before receiving the study drug for the first time (bleeding > 30 ml within 2 months, hematemesis, black stool and bloody stool), hemoptysis (fresh blood > 5 ml within 4 weeks);
  • Arterial thrombosis or deep venous thrombosis occurred within 6 months before the first study drug; or thromboembolic events (including stroke events and / or transient ischemic attack) occurred within 12 months;
  • Have active pulmonary tuberculosis, are receiving anti tuberculosis treatment or have received anti tuberculosis treatment within 1 year before receiving the study drug for the first time;
  • Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients who may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; radiation pneumonia in radiotherapy area is allowed;
  • Hepatitis B virus (HBV) DNA>1 is known to have clinically significant liver disease history, including viral hepatitis active infection (hepatitis B surface antigen HBsAg) and / or hepatitis B core antibody (HBcAb) positive. × 103 copies / ml or > 2000 IU / ml; Hepatitis C virus (HCV) antibody is known to be positive and HCV RNA > 1 × 103 copies / ml], or other hepatitis, clinically significant moderate and severe liver cirrhosis;
  • Human immunodeficiency virus (HIV) antibody positive;
  • Meet any of the following criteria related to cardiac function:
  • Various clinically significant arrhythmias or conduction abnormalities require clinical intervention;
  • At rest, the QT interval (QTCF) of electrocardiogram (ECG) was > 480 msec;
  • Note: if ECG cannot directly display QTCF results, please use the following formula for calculation: QTCF = QT / ∛ RR
  • Various clinically significant cardiovascular diseases, including acute myocardial infarction, severe or unstable angina pectoris, coronary artery bypass grafting, New York Heart Function Classification (NYHA) III / IV congestive heart failure, ventricular arrhythmia requiring treatment, or left ventricular ejection fraction (LVEF) < 50% within 6 months before the first study.
  • Women who are known to be pregnant or breastfeeding;
  • Known history of allergy to the relevant components of the study drug;
  • Subjects / patients who participated in other intervention clinical studies within 4 weeks before the first acceptance of the study drug;
  • There is any disease or condition affecting drug absorption, or the subject / patient cannot take the drug orally;
  • Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • For other reasons, the researcher judged that it was not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

Xiaowei Zhang, Doctor contact

021-64175590 ext. 88503

dongfangzhizizhxw@aliyun.com

Wenxia Peng, Bachelor contact

021-64433755

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiaowei Zhang, Doctor, 021-64175590 ext. 520, dongfangzhizizhxw@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Single Center, Open, Single Arm Phase II Clinical Study of Fruquintinib in the Treatment of Soft Tissue Sarcoma

To evaluate the efficacy of Fruquintinib in patients with chemotherapy insensitive or chemotherapy resistant soft tissue sarcoma

Read the detailed description

This trial is an open, single arm, single center, prospective phase II clinical study. Objective:To observe the efficacy and safety of Fruquintinib in the first-line treatment of desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or second-line and posterior line treatment of angiosarcoma.

Being tested
Fruquintinib
Keywords
soft tissue sarcoma, Fruquintinib
Medical subject headings
Sarcoma

What participants receive

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

  • FruquintinibDrug

    To observe the efficacy and safety of Fruquintinib in the first-line treatment of desmoplastic small round cell tumor, epithelioid hemangioendothelioma, solitary fibroma or second-line and posterior line treatment of angiosarcoma.

Study groups in NCT05142631
Study groupRoleWhat they receive
Fruquintinib in soft tissue sarcomaExperimentalFruquintinib : 5mg, once a day (QD), oral on an empty stomach or after a meal, taken with 100 ~ 200ml drinking water for 3 weeks and stopped for 1 week.
Receives: Drug: Fruquintinib

What is being measured

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

  1. PFS

    progression free survival

    Measured: 2 months

Secondary outcomes (6)

  1. ORR

    objective response rat

    Measured: 2 months

  2. OS

    over survival

    Measured: 6 months

  3. DCR

    disease control rate

    Measured: 2 months

  4. DoR

    duration of response

    Measured: 2 months

  5. TTR

    time to response

    Measured: 2 months

  6. AE

    Adverse Events

    Measured: 2 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 Dec 2021
  2. Study start21 Nov 2021
  3. Primary completion30 May 2023 (estimated)
  4. Study completion30 Aug 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
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142631
Sponsor's protocol ID
2021-013-CH05 IIT-STS
Status last verified
Mar 2022
First submitted
21 Nov 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib in people with Soft Tissue Sarcoma, run by Fudan 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 17 inclusion and 29 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 Mar 2022. 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?

Contact Xiaowei Zhang, Doctor (021-64175590 ext. 88503, dongfangzhizizhxw@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 2 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 NCT05142631.

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 Mar 2022.

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