Back to resultsStudy of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ridaforolimus
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring sarcoma, Ridaforolimus, soft tissue sarcoma, unresectable sarcoma
Eligibility Criteria
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
Sites / Locations
- Cancer Therapy & Research Center at UTHSCSA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AIM Arm
TG Arm
Arm Description
Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)
Ridaforolimus combined with docetaxel and gemcitabine (TG)
Outcomes
Primary Outcome Measures
Define maximum tolerated dose (MTD)
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
Secondary Outcome Measures
Number of Grade 2 or higher side effects with the combined therapy.
Any evidence of antitumor activity--as measured by response rate (RECIST).
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.
Full Information
NCT ID
NCT01296659
First Posted
February 3, 2011
Last Updated
July 11, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01296659
Brief Title
Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma
Official Title
Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left institution.
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
sarcoma, Ridaforolimus, soft tissue sarcoma, unresectable sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIM Arm
Arm Type
Experimental
Arm Description
Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)
Arm Title
TG Arm
Arm Type
Experimental
Arm Description
Ridaforolimus combined with docetaxel and gemcitabine (TG)
Intervention Type
Drug
Intervention Name(s)
ridaforolimus
Other Intervention Name(s)
deforolimus
Intervention Description
Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy
Primary Outcome Measure Information:
Title
Define maximum tolerated dose (MTD)
Description
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
Time Frame
12-18 months
Secondary Outcome Measure Information:
Title
Number of Grade 2 or higher side effects with the combined therapy.
Description
Any evidence of antitumor activity--as measured by response rate (RECIST).
Time Frame
12-18 months
Title
Pharmacokinetics
Description
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.
Time Frame
12-18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Mita, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Therapy & Research Center at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ctrc.net
Description
Cancer Therapy & Research Center's Website
Learn more about this trial
Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma
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