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

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.

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

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Ribociclib

Given PO

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Lara E Davis · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-10

Primary Completion

2019-10-08

Completion

2023-06-30

FDA Drug

Yes

Countries

• United States

Study Locations