Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma

The University of Texas System (UT)

Status and phase

Withdrawn

Phase 1

Conditions

Soft Tissue Sarcoma

Treatments

Drug: ridaforolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01296659

IDD 10-09

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count [ANC] ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; bilirubin ≤ ULN; alkaline phosphatase ≤ 2.5 x ULN; AST, ALT ≤ 2.5 x ULN; albumin ≥ 2.5mg/dL; creatinine ≤ 1.5 x ULN)
Serum cholesterol ≤ 350 mg/dL and triglycerides ≤400 mg/dL
Signed informed consent
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug.

Exclusion criteria

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
Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes
Have received >350 mg/m2 total dose of Doxorubicin
Active infection requiring prescribed intervention
Other concurrent illness
Major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days
Previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form AIM Arm enrollment
Pregnant or breastfeeding
Known allergy to macrolide antibiotics
Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A).
Known history of HIV sero-positivity