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Anti-tumor antibiotic

Pharmacological Study for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Led By Lara E Davis

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is studying the side effects and best dose of ribociclib when given together with doxorubicin hydrochloride to treat patients with advanced soft tissue sarcoma.

Eligible Conditions

Soft Tissue Sarcoma
Angiosarcoma
Leiomyosarcoma
Liposarcoma
Peripheral Nerve Sheath Tumor
Myxofibrosarcoma
Pleomorphic Sarcoma
Fibrosarcoma
Synovial Sarcoma
Rhabdomyosarcoma
Undifferentiated Sarcoma
Epithelioid Sarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs) of adverse events

Secondary outcome measures

Incidence of adverse events, SAEs

Incidence of dose modifications (interruptions, reductions, intensity) due to adverse events

Objective response rate (ORR)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ribociclib, doxorubicin hydrochloride)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Ribociclib

2018

Completed Phase 3

~2330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

228 Previous Clinical Trials

2,090,659 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

970 Previous Clinical Trials

6,845,922 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,727 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What diseases are regularly addressed by Pharmacological Study?

"Pharmacological Study is commonly used to treat Kaposi's Sarcoma in those affected by AIDS. It has also proven effective for suppressing the spread of neoplasm metastasis, breast cancer, and advanced thymoma."

Answered by AI

Is there still registration availability for this clinical research?

"The trial has since concluded and is no longer recruiting patients. The inquiry was initially posted on March 10th 2017 before it's final editing session on June 13th 2022. If you are in search of further research, there are 523 studies currently enrolling individuals with malignant neoplasms and a separate 407 trials to participate in Pharmacological Studies."

Answered by AI

What prior research has been done on the subject of pharmacology?

"Currently, 407 investigations concerning Pharmacological Study are underway. Of the total studies, 126 have reached phase 3 and there are 25045 sites running trials for this pharmacological intervention; with most centred in New york City."

Answered by AI

Has this kind of research ever been conducted before?

"Currently, 407 live trials for Pharmacological Study are being conducted in 2118 cities and 68 countries. This research endeavor first began with the 1997 Alfacell-sponsored trial of 300 participants that achieved Phase 3 drug approval status. Since then, 1273 trials have concluded."

Answered by AI

What is the safety profile of this pharmacological research?

"Our team at Power rates the safety of Pharmacological Study a 1 due to its Phase 1 classification, which implies there is only minimal data regarding efficacy and security."

Answered by AI

How many individuals are enrolled in this investigation?

"This trial is no longer open to recruitment. It was first published on March 10th 2017, and last modified June 13th 2022. However, currently 523 malignant neoplasms trials are actively recruiting patients, as well as 407 Pharmacological Studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lara Davis, MD 2017. "Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03009201.