NCT03009201

Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery

A Phase 1B Study of Ribociclib in Combination With Doxorubicin in Advanced Soft Tissue Sarcomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.

Detailed description

PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas. SECONDARY OBJECTIVES: I. To assess preliminary anti-tumor activity of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas. II. To characterize the safety and tolerability of ribociclib in combination with doxorubicin. OUTLINE: This is a dose-escalation study of ribociclib. Patients receive ribociclib orally (PO) daily on days 1-7, and doxorubicin hydrochloride intravenously (IV) on day 10. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients without disease progression after 6 cycles receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days and then every 12 weeks for 12 months.

Conditions

• Advanced Soft Tissue Sarcoma
• Locally Advanced Angiosarcoma
• Locally Advanced Leiomyosarcoma
• Locally Advanced Liposarcoma
• Locally Advanced Malignant Peripheral Nerve Sheath Tumor
• Locally Advanced Myxofibrosarcoma
• Locally Advanced Undifferentiated Pleomorphic Sarcoma
• Metastatic Angiosarcoma
• Metastatic Epithelioid Sarcoma
• Metastatic Fibrosarcoma
• Metastatic Liposarcoma
• Metastatic Malignant Peripheral Nerve Sheath Tumor
• Metastatic Myxofibrosarcoma
• Metastatic Soft Tissue Sarcoma
• Metastatic Synovial Sarcoma
• Metastatic Undifferentiated Pleomorphic Sarcoma
• Myxofibrosarcoma
• Pleomorphic Rhabdomyosarcoma
• Stage III Soft Tissue Sarcoma AJCC v7
• Stage IV Soft Tissue Sarcoma AJCC v7
• Undifferentiated (Embryonal) Sarcoma
• Unresectable Leiomyosarcoma
• Unresectable Liposarcoma
• Unresectable Malignant Peripheral Nerve Sheath Tumor
• Unresectable Soft Tissue Sarcoma
• Unresectable Synovial Sarcoma
• Unresectable Undifferentiated Pleomorphic Sarcoma

Interventions

Type	Name	Description
DRUG	Doxorubicin Hydrochloride	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Ribociclib	Given PO

Timeline

• Start date: 2017-03-10
• Primary completion: 2019-10-08
• Completion: 2023-06-30
• First posted: 2017-01-04
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study