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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01296659
• Other study ID #: IDD 10-09
• Status: Withdrawn
• Phase: Phase 1
• First received: February 3, 2011
• Last updated: July 11, 2012
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• ridaforolimus
Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy

Locations

Country	Name	City	State
United States	Cancer Therapy & Research Center at UTHSCSA	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define maximum tolerated dose (MTD)	Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy	12-18 months	Yes
Secondary	Number of Grade 2 or higher side effects with the combined therapy.	Any evidence of antitumor activity--as measured by response rate (RECIST).	12-18 months	No
Secondary	Pharmacokinetics	Ridaforolimus pharmacokinetics when given in combination with SOC chemotherapy. Limited PK for SOC chemotherapy when combined with ridaforlimus. We will measure change in concentration of Ridaforolimus when combined with chemotherapy.	12-18 months	Yes

External Links

•   Cancer Therapy & Research Center's Website