BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases (NCT04183062) | Clinical Trial Compass
WithdrawnPhase 2
BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
Stopped: The drug for this study was not available by the manufacturer. No patients enrolled.
United States0Started 2019-10-04
Plain-language summary
This is a Phase 2 study of an investigational drug, BIO-11006, for the treatment of lung metastases in pediatric patients with advanced osteosarcoma or Ewing's sarcoma. This study will enroll up to 10 patients aged between 5 and 21 at Nicklaus Children's Hospital in Miami, FL. Patients will receive BIO-11006 in addition to chemotherapy consisting of gemcitabine and docetaxel. This study will test the hypothesis that BIO-11006 will enhance the effect of the gemcitabine and docetaxel chemotherapy to treat lung metastases in osteosarcoma and Ewing's sarcoma.
Who can participate
Age range5 Years – 21 Years
SexALL
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Inclusion criteria
✓. Histologic verification of Ewing's sarcoma or osteosarcoma at original diagnosis or at relapse
✓. Recurrence within one year of end of previous therapy
✓. Presence of lung metastases
✓. Osteosarcoma patients must be ineligible for curative surgery
✓. Ability to take inhaled medication by nebulizer and be willing to adhere to the BIO-11006 regimen
✓. Females of reproductive potential must have a negative pregnancy test at screening and must agree to use a method of highly effective contraception during study participation.
✓. Males of reproductive potential must agree to the use of condoms or other methods to ensure effective contraception with partner
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
✕. Previously treated and progressed on gemcitabine and docetaxel