Soft Tissue SarcomaPhase 1NCT01296659
Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Soft Tissue Sarcoma
A Phase 1 study testing ridaforolimus in people with Soft Tissue Sarcoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- ridaforolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: 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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- ridaforolimus
- Keywords
- sarcoma, Ridaforolimus, soft tissue sarcoma, unresectable sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimusDrug
Also called deforolimus
Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| AIM Arm | Experimental | Ridaforolimus combined with doxorubicin/ifosfamide/mesma (AIM) Receives: Drug: ridaforolimus |
| TG Arm | Experimental | Ridaforolimus combined with docetaxel and gemcitabine (TG) Receives: Drug: ridaforolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define maximum tolerated dose (MTD)
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
Measured: 12-18 months
Secondary outcomes (2)
Number of Grade 2 or higher side effects with the combined therapy.
Any evidence of antitumor activity--as measured by response rate (RECIST).
Measured: 12-18 months
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.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Principal Investigator left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Monica Mita, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296659
- Sponsor's protocol ID
- IDD 10-09
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Oral Ridaforolimus in Combination With Standard Chemotherapy for Patients With Advanced Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01296659
- Acronym / sponsor ID
- IDD 10-09
- Conditions
- Soft Tissue Sarcoma
- Keywords
- sarcoma, Ridaforolimus, soft tissue sarcoma, unresectable sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM Arm | Experimental | Drug: ridaforolimusRidaforolimus combined with doxorubicin/ifosfamide/mesma (AIM) |
| TG Arm | Experimental | Drug: ridaforolimusRidaforolimus combined with docetaxel and gemcitabine (TG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ridaforolimusAlso: deforolimusRidaforolimus administered orally 5 days per week in combination with standard chemotherapy | Drug | AIM Arm, TG Arm |
Primary outcome
Define maximum tolerated dose (MTD)
Time frame: 12-18 months
Defining the maximum tolerated dose (MTD) and recommended Phase II dose for the combination ridaforolimus and SOC chemotherapy
2 secondary outcomes
Number of Grade 2 or higher side effects with the combined therapy.
Time frame: 12-18 months
Pharmacokinetics
Time frame: 12-18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Cancer Therapy \& Research Center's WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Mita, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ridaforolimus in people with Soft Tissue Sarcoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define maximum tolerated dose (MTD) (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.