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Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma

Phase 1
18 Years
Not Enrolling
Soft Tissue Sarcoma

Thank you

Trial Information

Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma

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

Exclusion Criteria:

- Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.

- Clinically significant unexplained bleeding within 28 days prior to entering the

- Uncontrolled systemic vascular hypertension

- Clinically significant cardiovascular disease

- Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define maximum tolerated dose (MTD)

Outcome Description:

Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy

Outcome Time Frame:

12-18 months

Safety Issue:


Principal Investigator

Monica Mita, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center at San Antonio


United States: Food and Drug Administration

Study ID:

IDD 10-09



Start Date:

February 2011

Completion Date:

August 2011

Related Keywords:

  • Soft Tissue Sarcoma
  • sarcoma
  • Ridaforolimus
  • soft tissue sarcoma
  • unresectable sarcoma
  • Sarcoma



Cancer Therapy & Research Center at UTHSCSASan Antonio, Texas  78229