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New treatment option for Effectiveness
Official title Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT05617859
What this study is testing
What is Lenvatinib mesylate capsule?
Lenvatinib mesylate capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for effectiveness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 70
You may be able to join if
- Ages 10-70, both male and female.
- The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. people with amputation can be relaxed up to 2 points.
- The expected survival time was ≥3 months.
- people with bone and soft tissue sarcomas with distant metastases or locally advanced disease who were not considered suitable for surgical treatment...
- Patients who had been treated with apatinib or anlotinib in the past, and the how well it works was evaluated as CR\\PR\\SD\\PD, and had no response...
You likely can't join if
- by day 1 of the first cycle (C1D1), except for toxicities such as hair loss that the investigator considered to pose no safety risk to the subject.
- Adequate organ and bone marrow function is defined as follows: Blood routine (no blood transfusion, no G-CSF, no medication correction within 14 days...
- Urine routine: urinary protein \<2+; If urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
- Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; FT3(T3) and FT4(T4) levels should be examined if they are abnormal, and normal FT3(T3) and...
- Female people of reproductive age must have a negative serum pregnancy test within 7 days prior to medication and be willing to use a medically...
- I have AGREED and signed the informed CONSENT, and I am willing AND ABLE TO comply with the planned visit, study treatment, laboratory tests and...
See the full eligibility criteria
- Ages 10-70, both male and female.
- The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. people with amputation can be relaxed up to 2 points.
- The expected survival time was ≥3 months.
- people with bone and soft tissue sarcomas with distant metastases or locally advanced disease who were not considered suitable for surgical treatment by the investigator.
- Patients who had been treated with apatinib or anlotinib in the past, and the how well it works was evaluated as CR\\PR\\SD\\PD, and had no response to other systemic therapy after drug resistance, or had reprogression...
- There were measurable lesions that met RECIST1.1 criteria.
- All acute toxicities from previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE, version 4.03) or to enrollment/
- by day 1 of the first cycle (C1D1), except for toxicities such as hair loss that the investigator considered to pose no safety risk to the subject.
- Adequate organ and bone marrow function is defined as follows: Blood routine (no blood transfusion, no G-CSF, no medication correction within 14 days before screening) : Neutrophil count (ANC)≥1,500/mm3(1.5×109/L)...
- Urine routine: urinary protein \<2+; If urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
- Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; FT3(T3) and FT4(T4) levels should be examined if they are abnormal, and normal FT3(T3) and FT4(T4) levels can be selected.
- Female people of reproductive age must have a negative serum pregnancy test within 7 days prior to medication and be willing to use a medically approved highly effective contraceptive (e.g., intrauterine device, birth...
- I have AGREED and signed the informed CONSENT, and I am willing AND ABLE TO comply with the planned visit, study treatment, laboratory tests and other trial procedures. Exclusion Criteria:
- C1D1 received the following treatments in the previous 4 weeks: Radiotherapy, surgery, chemotherapy, immunotherapy for tumors. Other investigational drugs. Get live attenuated vaccine.
- Surgery and/or radiation therapy for bone and soft tissue sarcomas were planned during the study.
- Previous use of immunosuppressive drugs within 14 days prior to C1D1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10mg/ day of prednisolone...
- Severe infection (such as the need for intravenous antibiotic, antifungal, or antiviral medication) within 4 weeks prior to C1D1, or unexplained fever \>38.5°C during the screening period/before the first dose.
- Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90mmHg).
- Significant bleeding symptoms or clear bleeding tendency occurred within 3 months before C1D1, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, vasculitis, etc. Or...
- Active heart disease in the 6 months prior to C1D1, including myocardial infarction and severe/unstable angina pectoris. Left ventricular ejection fraction \ 450ms in men and \>470ms in women).
- C1D1 had been diagnosed with any other malignancy within 3 years prior to C1D1, except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix.
- Known allergy to the study drug or any of its excipients.
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBVDNA≥500IU/ml), and hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the...
- Concomitant diseases (e.g., poorly controlled hypertension, severe diabetes,neurological or mental disorders, etc.) or any other conditions that, in the judgment of the investigator, seriously endanger the safety of the...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.