Neoplasms

All Conditions

Nervous System Diseases

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sarcoma

Histiocytoma, Malignant Fibrous

Liposarcoma

Fibrosarcoma

Hemangiosarcoma

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Nerve Sheath Neoplasms

Neurofibrosarcoma

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Myosarcoma

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Neoplasms, Vascular Tissue

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplasms, Fibrous Tissue

Neurofibromatoses

Neurofibroma

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Epithelioid Sarcoma

Neurofibromatosis

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients receive ribociclib PO daily on days 1-7, and doxorubicin hydrochloride 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 receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride

Laboratory Biomarker Analysis

Pharmacological Study

Ribociclib

Lara E Davis

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.

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.

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

Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. All adverse events (AEs) will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.

The Kaplan-Meier product limit method will be used to estimate PFS of the median PFS and PFS rates at clinically relevant time points will be provided with the 90% confidence interval (CI).

Will be defined as the proportion of patients who achieved a complete response or a partial response. Will be assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1. The ORR, along with exact two-sided 95% confidence intervals, will be reported for the study.

Will be assessed by NCI CTCAE v 4.03. Analyses will be performed for all patients having received at least one dose of study drug. Serious adverse events, AEs will be summarized using descriptive statistics.

Analyses will be performed for all patients having received at least one dose of study drug. AEs leading to withdrawal/dose interruptions/dose modification will be summarized using descriptive statistics.

Novartis Pharmaceuticals

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery	NCT03009201	Advanced Soft T... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Metastatic Angi... Metastatic Epit... Metastatic Fibr... Metastatic Lipo... Metastatic Mali... Metastatic Myxo... Metastatic Soft... Metastatic Syno... Metastatic Undi... Myxofibrosarcom... Pleomorphic Rha... Stage III Soft ... Stage IV Soft T... Undifferentiate... Unresectable Le... Unresectable Li... Unresectable Ma... Unresectable So... Unresectable Sy... Unresectable Un...	Doxorubicin Hyd... Laboratory Biom... Pharmacological... Ribociclib	12 Years -	OHSU Knight Cancer Institute
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery	NCT03009201	Advanced Soft T... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Metastatic Angi... Metastatic Epit... Metastatic Fibr... Metastatic Lipo... Metastatic Mali... Metastatic Myxo... Metastatic Soft... Metastatic Syno... Metastatic Undi... Myxofibrosarcom... Pleomorphic Rha... Stage III Soft ... Stage IV Soft T... Undifferentiate... Unresectable Le... Unresectable Li... Unresectable Ma... Unresectable So... Unresectable Sy... Unresectable Un...	Doxorubicin Hyd... Laboratory Biom... Pharmacological... Ribociclib	12 Years -	OHSU Knight Cancer Institute
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery	NCT03009201	Advanced Soft T... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Locally Advance... Metastatic Angi... Metastatic Epit... Metastatic Fibr... Metastatic Lipo... Metastatic Mali... Metastatic Myxo... Metastatic Soft... Metastatic Syno... Metastatic Undi... Myxofibrosarcom... Pleomorphic Rha... Stage III Soft ... Stage IV Soft T... Undifferentiate... Unresectable Le... Unresectable Li... Unresectable Ma... Unresectable So... Unresectable Sy... Unresectable Un...	Doxorubicin Hyd... Laboratory Biom... Pharmacological... Ribociclib	12 Years -	OHSU Knight Cancer Institute

Spots Global Cancer Trial Database for unresectable undifferentiated pleomorphic sarcoma