CompletedPhase 2

Eribulin in Advanced Solitary Fibrous Tumor

Italy16 participantsStarted 2019-07-17

Plain-language summary

Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
✓. Age ≥18 years
✓. Histological centrally and molecular confirmed diagnosis SFT
✓. Locally advanced disease and/or metastatic disease
✓. Measurable disease according RECIST 1.1
✓. Evidence of progression by RECIST 1.1 during the 6 months before study entry
✓. Patients must be treated with at least one prior medical anticancer treatment line for the advanced phase of disease (both cytotoxic chemotherapy or target treatment allowed) and with a maximum of 2 lines.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

✕. Naïve patients
✕. More than 2 lines of anticancer treatment
✕. Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing,
✕. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
✕. Previous radiotherapy to 25% of the bone marrow
✕. Major surgery within 21 days prior to study entry
✕. Other primary malignancy with \<5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
✕. Pregnancy or breast feeding

RECIST 1.1 Overall response rate

Timeframe: At week 6

NCT IDNCT03840772

SponsorItalian Sarcoma Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-09-18

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
✓. Age ≥18 years
✓. Histological centrally and molecular confirmed diagnosis SFT
✓. Locally advanced disease and/or metastatic disease
✓. Measurable disease according RECIST 1.1
✓. Evidence of progression by RECIST 1.1 during the 6 months before study entry
✓. Patients must be treated with at least one prior medical anticancer treatment line for the advanced phase of disease (both cytotoxic chemotherapy or target treatment allowed) and with a maximum of 2 lines.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

✕. Naïve patients
✕. More than 2 lines of anticancer treatment
✕. Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing,
✕. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
✕. Previous radiotherapy to 25% of the bone marrow
✕. Major surgery within 21 days prior to study entry
✕. Other primary malignancy with \<5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
✕. Pregnancy or breast feeding