Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas

Inclusion Criteria

• •1. The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
• •2. Age ≥ 18 years.
• •3. Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxoid and hypercellular myxoid liposarcoma, myxofibrosarcoma, NOS sarcoma, synovial sarcoma, fibrosarcoma, or malignant nerve sheath tumor) confirmed by central pathology review.
• •4. Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
• •5. The patient must be willing to undergo a second mandatory biopsy just before the initiation of the 3rd cycle and agree that this sample is used for the translational study.
• •6. Measurable disease according to RECIST v1.1 criteria.
• •7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• •8. The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
• •9. Adequate organ, hepatic, renal, cardiac, and hematologic function.
• •10. Laboratory tests as follows:
• •* Absolute neutrophil count ≥ 1,200/mm³
• •* Platelet count ≥ 100,000/mm³
• •* Hg \> 9 g/dL
• •* Bilirubin ≤ 1.5 mg/dL
• •* PT and INR ≤ 1.5
• •* AST and ALT ≤ 2.5 times ULN
• •* Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
• •* Blood glucose \< 150 mg/dL
• •11. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
• •12. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
• •13. Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.
• •1. The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtainedprior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
• •2. Age ≥ 18 years.
• •3. Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma or leiomyosarcoma) confirmed by central pathology review.
• •4. Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
• •5. Measurable disease according to RECIST v1.1 criteria.
• •6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• •7. The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
• •8. Adequate organ, hepatic, renal, cardiac, and hematologic function.
• •9. Laboratory tests as follows:
• •* Absolute neutrophil count ≥ 1,200/mm³
• •* Platelet count ≥ 100,000/mm³
• •* Hg \> 9 g/dL
• •* Bilirubin ≤ 1.5 mg/dL
• •* PT and INR ≤ 1.5
• •* AST and ALT ≤ 2.5 times ULN
• •* Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
• •* Blood glucose \< 150 mg/dL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
• •11\. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
• •12\. Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.