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

NCT ID: NCT01296659

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Sarcoma

Keywords

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sarcoma Ridaforolimus soft tissue sarcoma unresectable sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AIM Arm

Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)

Group Type EXPERIMENTAL

ridaforolimus

Intervention Type DRUG

Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy

TG Arm

Ridaforolimus combined with docetaxel and gemcitabine (TG)

Group Type EXPERIMENTAL

ridaforolimus

Intervention Type DRUG

Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy

Interventions

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ridaforolimus

Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy

Intervention Type DRUG

Other Intervention Names

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deforolimus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica Mita, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.ctrc.net

Cancer Therapy \& Research Center's Website

Other Identifiers

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IDD 10-09

Identifier Type: -

Identifier Source: org_study_id