Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

NCT05617859 | Recruiting Phase 2 DMC

• 1 other identifier: ZZUSC-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effectiveness; Sexuality

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  From the start of treatment to the onset of disease progression or death of the patient

  Up to approximately 24months

• Objective response rate

  Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it

  Up to approximately 24months

Study Arms (1)

Lenvatinib mesylate capsule

OTHER

Eligible subjects with bone and soft tissue sarcoma were selected and treated with the following treatment regimens:Subjects will receive Lenvatinib mesylate capsules, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg) orally once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.

Drug: Lenvatinib mesylate capsule

Interventions

Lenvatinib mesylate capsule DRUG

Lenvatinib mesylate capsule, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg), orally, once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.

Lenvatinib mesylate capsule

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 10-70, both male and female.
• The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. Subjects with amputation can be relaxed up to 2 points.
• The expected survival time was ≥3 months.
• Subjects 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 efficacy was evaluated as CR\\PR\\SD\\PD, and had no response to other systemic therapy after drug resistance, or had reprogression after more than 3 months.
• There were measurable lesions that met RECIST1.1 criteria.

You may not qualify if:

• 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); Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);
• Blood biochemical:
• Serum creatinine (Cr)≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;
• Blood coagulation function:
• International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN;
• 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 subjects 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 control pill, or condom) during the study period and within 3 months after the last administration of the study drug; Male subjects with a female partner of reproductive age were required to undergo surgical sterilization or consent to use an effective method of contraception during the study period and for 3 months after the last study dose.
• 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.
• 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 or an equivalent physiological dose of another corticosteroid).

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Sexuality

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 16, 2022
• Study Start: April 30, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)