Suspended
Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma
What is being tested
ridaforolimus
Drug
Who is being recruted
Neoplasms+1
+ Neoplasms by Histologic Type
+ Sarcoma
Over 18 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: February 2011
Summary
Principal SponsorThe University of Texas Health Science Center at San Antonio
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2011
Actual date on which the first participant was enrolled.Ridaforolimus has been tested in almost 2 dozen studies; however, it has not previously been tested in combination with the standard of care chemotherapy for sarcoma as this study will. We will be looking to see if Ridaforolimus given with SOC chemo (AIM or TG) is well tolerated and to determine a Phase 2 dose.
Official TitlePhase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma
Principal SponsorThe University of Texas Health Science Center at San Antonio
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
NeoplasmsNeoplasms by Histologic TypeSarcomaNeoplasms, Connective and Soft Tissue
Criteria
8 inclusion criteria required to participate
Advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. No more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase.
ECOG performance status of ≤ 1
A minimum life expectancy > 3 months
At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus
Show More Criteria
14 exclusion criteria prevent from participating
Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
Clinically significant unexplained bleeding within 28 days prior to entering the trial
Uncontrolled systemic vascular hypertension
Clinically significant cardiovascular disease
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalRidaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)
Group II
ExperimentalRidaforolimus combined with docetaxel and gemcitabine (TG)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Cancer Therapy & Research Center at UTHSCSA
San Antonio, United StatesOpen Cancer Therapy & Research Center at UTHSCSA in Google MapsSuspendedOne Study Center