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

This study has been withdrawn prior to enrollment.
(Principal Investigator left institution.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01296659
First received: February 3, 2011
Last updated: July 11, 2012
Last verified: July 2012

February 3, 2011
July 11, 2012
February 2011
August 2011   (final data collection date for primary outcome measure)
Define maximum tolerated dose (MTD) [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
Same as current
Complete list of historical versions of study NCT01296659 on ClinicalTrials.gov Archive Site
  • Number of Grade 2 or higher side effects with the combined therapy. [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
    Any evidence of antitumor activity--as measured by response rate (RECIST).
  • Pharmacokinetics [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma
Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Soft Tissue Sarcoma
Drug: ridaforolimus
Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy
Other Name: deforolimus
  • Experimental: AIM Arm
    Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)
    Intervention: Drug: ridaforolimus
  • Experimental: TG Arm
    Ridaforolimus combined with docetaxel and gemcitabine (TG)
    Intervention: Drug: ridaforolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01296659
IDD 10-09
Yes
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Merck Sharp & Dohme Corp.
Principal Investigator: Monica Mita, MD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP