BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04183062|
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : May 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Metastatic Ewing's Sarcoma Metastatic||Drug: Chemotherapy (gemcitabine & docetaxel) plus BIO-11006||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of the Safety and Efficacy of BIO-11006 in the Treatment of Recurrent Osteosarcoma and Ewing's Sarcoma in Patients With Lung Metastases|
|Actual Study Start Date :||October 4, 2019|
|Estimated Primary Completion Date :||November 4, 2022|
|Estimated Study Completion Date :||November 4, 2023|
Experimental: Chemotherapy plus BIO-11006
Patients will receive BIO-11006 in addition to GemTax chemotherapy. The BIO-11006 inhalation solution will be given by mouth inhalation twice daily. BIO-11006 will be given during the first three cycles of GemTax and then will be stopped. Subjects will continue with GemTax treatment for three additional cycles. If the patient shows lung progression (either clinical or on imaging) at any point after cycle 4 has been given, but had shown at least a partial response during the tumor assessment after cycle 3, BIO-11006 may be re-started at the discretion of the investigator and continued for the duration of the GemTax treatment.
Drug: Chemotherapy (gemcitabine & docetaxel) plus BIO-11006
BIO-11006 will be administered at a dose of 75 mg twice daily for patients over 5 years of age and under 18 years of age or 125 mg twice daily for patients 18 years of age or older. The study drug will be administered twice daily by nebulizer over 20 minutes.
GemTax will be administered in 21-day cycles. Gemcitabine will be administered at a dose of 900 mg/m2 IV over 90 minutes on days 1 and 8. Docetaxel will be administered at a dose of 75 mg/m2 IV over 60 minutes on day 8.
- Safety - Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 16 months ]Frequency, type, severity, and duration of TEAEs. Sources of TEAEs may include spontaneous patient reports, results of physical examinations, and clinical laboratory measurements. Simple descriptive statistics of frequencies, centrality and variability will be utilized to tabulate and summarize TEAEs. If sufficient number of TEAEs will be captured, frequencies, duration and severity will be compared.
- Efficacy - Progression Free Survival (PFS) [ Time Frame: Up to 16 months ]PFS will be measured from Cycle 1 Day 1 until occurrence of event (such as death, disease progression or end of study).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183062
|Contact: Guillermo De Angulo, MDfirstname.lastname@example.org|
|Contact: Guido Elias, CRCemail@example.com|
|United States, Florida|
|Nicklaus Children's Hospital||Recruiting|
|Miami, Florida, United States, 33155|
|Contact: Guillermo De Angulo, MD 786-624-3513 firstname.lastname@example.org|
|Contact: Guido Elias, CRC 786-624-3513 email@example.com|
|Principal Investigator: Guillermo De Angulo, MD|
|Principal Investigator:||Guillermo De Angulo, MD||Nicklaus Children's Hospital|