Anti-tumor antibiotic

Pharmacological Study for Soft Tissue Sarcoma

OHSU Knight Cancer Institute, Portland, OR
Targeting 27 different conditionsPharmacological Study +3 morePhase 1Waitlist AvailableLed by Lara E DavisResearch Sponsored by OHSU Knight Cancer Institute

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a specific type of soft tissue cancer that can be treated with a specific chemotherapy drug. You must have a certain level of heart function, and meet specific blood test and ECG requirements. You must not be pregnant and must use contraception throughout the study. You cannot be taking certain blood thinners. You must have completed prior treatments within specific timeframes and have no significant side effects. You must be able to swallow capsules and have a certain level of physical function. You must be able to understand and agree to the study's requirements.


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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved

Find a site

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
218 Previous Clinical Trials
2,089,392 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
931 Previous Clinical Trials
6,830,143 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,799 Previous Clinical Trials
4,024,253 Total Patients Enrolled
Lara E DavisPrincipal Investigator
OHSU Knight Cancer Institute
3 Previous Clinical Trials
37 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
~2 spots leftby Sep 2024