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

NCT01296659 | Withdrawn Phase 1 DMC

• 1 other identifier: IDD 10-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Keywords

sarcoma; Ridaforolimus; soft tissue sarcoma; unresectable sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Grade 2 or higher side effects with the combined therapy.

  12-18 months

• Pharmacokinetics

  12-18 months

Study Arms (2)

AIM Arm

EXPERIMENTAL

Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM)

Drug: ridaforolimus

TG Arm

EXPERIMENTAL

Ridaforolimus combined with docetaxel and gemcitabine (TG)

Drug: ridaforolimus

Interventions

ridaforolimus DRUG

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

Also known as: deforolimus

AIM Arm; TG Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Related Links

• Cancer Therapy \& Research Center's Website

MeSH Terms

Conditions

Sarcoma

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Monica Mita, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

US (1)