BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases
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ClinicalTrials.gov Identifier: NCT04183062 |
Recruitment Status :
Recruiting
First Posted : December 3, 2019
Last Update Posted : May 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Osteosarcoma Metastatic Ewing's Sarcoma Metastatic | Drug: Chemotherapy (gemcitabine & docetaxel) plus BIO-11006 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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).

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Ages Eligible for Study: | 5 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Provision of signed and dated informed consent form
Exclusion Criteria:
- Previously treated and progressed on gemcitabine and docetaxel
- Central Nervous System (CNS) metastases
- Contraindication to gemcitabine or docetaxel
- Known allergic reactions to components of BIO-11006
- Use of medications that are primarily metabolized by cytochrome P450 isoenzymes
- Treatment with another investigational drug within 8 weeks of enrollment.
- Current pneumonia or idiopathic pulmonary fibrosis
- Absolute Neutrophil Count (ANC) < 750 cells/mm3
- Platelet count < 75,000 cells/mm3
- Hemoglobin <8.0 g/dL
- Creatinine clearance (CrCL) < 45 mL/min
- Bilirubin > upper limit of normal (ULN) for age
- AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
- Organ transplant or bone marrow transplant recipient
- Pregnancy or lactation
- Current smoker or tobacco use within 3 months prior to enrollment
- Any febrile illness or other severe illness within 2 weeks of enrollment
- Known history of human immunodeficiency virus, hepatitis B, hepatitis C or tuberculosis

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, MD | 786-624-3513 | guillermo.deangulo@nicklaushealth.org | |
Contact: Guido Elias, CRC | 786-624-3513 | guido.elias@nicklaushealth.org |
United States, Florida | |
Nicklaus Children's Hospital | Recruiting |
Miami, Florida, United States, 33155 | |
Contact: Guillermo De Angulo, MD 786-624-3513 guillermo.deangulo@nicklaushealth.org | |
Contact: Guido Elias, CRC 786-624-3513 guido.elias@nicklaushealth.org | |
Principal Investigator: Guillermo De Angulo, MD |
Principal Investigator: | Guillermo De Angulo, MD | Nicklaus Children's Hospital |
Responsible Party: | Nicklaus Children's Hospital f/k/a Miami Children's Hospital |
ClinicalTrials.gov Identifier: | NCT04183062 |
Other Study ID Numbers: |
2019023 |
First Posted: | December 3, 2019 Key Record Dates |
Last Update Posted: | May 13, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
bone cancer sarcoma lung metastases pediatric cancers |
Neoplasm Metastasis Sarcoma Osteosarcoma Sarcoma, Ewing Neoplastic Processes Neoplasms Pathologic Processes Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Gemcitabine Docetaxel |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators |