LeiomyosarcomaPhase 2NCT00093080
Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)
A Phase 2 study testing ridaforolimus in people with Leiomyosarcoma and Liposarcoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Leiomyosarcoma, Liposarcoma, Osteosarcoma
- What is being tested?
- ridaforolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Nov 2008
- Phase
- Phase 2
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months
- Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Minimum life expectancy of 3 months
- Adequate renal and hepatic function, as specified in the protocol
- Adequate bone marrow function, as specified in the protocol
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- Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
- Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
- Able to understand and give written informed consent
Who cannot join
- Women who are pregnant or lactating
- Presence of brain metastases
- Prior therapy with rapamycin, rapamycin analogues or tacrolimus
- Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus
- Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)
- Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
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- Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
- Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
- Significant uncontrolled cardiovascular disease
- Active infection requiring systemic therapy
- Known human immunodeficiency virus (HIV) infection
- Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus
- Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug
- Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus
- Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
About this study
Official title: A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma
The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.
- Conditions
- Leiomyosarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Soft Tissue, Metastases
- Being tested
- ridaforolimus
- Keywords
- Metastatic and/or unresectable soft tissue or
- Medical subject headings
- Leiomyosarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimusDrug
Also called deforolimus (until May 2009), AP23573, MK-8669
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ridaforolimus | Experimental | 12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks Receives: Drug: ridaforolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
Measured: Day 1 up to 4 years or discontinuation from study
Secondary outcomes (7)
Time to Tumor Progression
Measured: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Progression Free Survival
Measured: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Overall Survival
Measured: Day 1 to the date of death, or the date of last contact (up to 4 years)
Duration of Response
Measured: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Number of participants experiencing adverse events
Measured: From first dose up to 30 days after last dose (up to 1 year)
Number of participants who discontinued study drug due to adverse events
Measured: From first dose up to the last dose (up to 1 year)
Mean ridaforolimus blood levels within 5 minutes post intravenous infusion
Measured: Day 1 and Day 5 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2004 (estimated)
- Study startOct 2004
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093080
- Sponsor's protocol ID
- 8669-018
- Other IDs
- AP23573-04-202, 2004-002231-92, 2004
- Status last verified
- Feb 2015
- First submitted
- 30 Sep 2004
- Last updated
- 13 Feb 2015
- Results posted
- No
Publications
Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska FG, Demetri GD. Phase II study of the mammalian target of rapamycin inhibitor ridaforolimus in patients with advanced bone and soft tissue sarcomas. J Clin Oncol. 2012 Jan 1;30(1):78-84. doi: 10.1200/JCO.2011.35.6329. Epub 2011 Nov 7.
PubMed 22067397
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma
- ClinicalTrials.gov ID
- NCT00093080
- Acronym / sponsor ID
- 8669-018
- Conditions
- Leiomyosarcoma, Liposarcoma, Osteosarcoma, Sarcoma, Soft Tissue, Metastases
- Keywords
- Metastatic and/or unresectable soft tissue or
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Oct 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Oct 2004 (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.
The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ridaforolimus | Experimental | Drug: ridaforolimus12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months
- Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Minimum life expectancy of 3 months
- Adequate renal and hepatic function, as specified in the protocol
Key exclusion criteria (15 listed)
- Women who are pregnant or lactating
- Presence of brain metastases
- Prior therapy with rapamycin, rapamycin analogues or tacrolimus
- Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus
- Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)
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: deforolimus (until May 2009), AP23573, MK-866912.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks | Drug | Ridaforolimus |
Primary outcome
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST)
Time frame: Day 1 up to 4 years or discontinuation from study
7 secondary outcomes
Time to Tumor Progression
Time frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Progression Free Survival
Time frame: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Overall Survival
Time frame: Day 1 to the date of death, or the date of last contact (up to 4 years)
Duration of Response
Time frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years)
Number of participants experiencing adverse events
Time frame: From first dose up to 30 days after last dose (up to 1 year)
Number of participants who discontinued study drug due to adverse events
Time frame: From first dose up to the last dose (up to 1 year)
Mean ridaforolimus blood levels within 5 minutes post intravenous infusion
Time frame: Day 1 and Day 5 of Cycle 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Results publication: PubMed 22067397Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska FG, Demetri GD. Phase II study of the mammalian target of rapamycin inhibitor ridaforolimus in patients with advanced bone and soft tissue sarcomas. J Clin Oncol. 2012 Jan 1;30(1):78-84. doi: 10.1200/JCO.2011.35.6329. Epub 2011 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ridaforolimus in people with Leiomyosarcoma and Liposarcoma, run by Merck Sharp & Dohme LLC.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST) (time frame: Day 1 up to 4 years or discontinuation from study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093080, which also lists 1 linked publication.
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 13 Feb 2015.