Metastatic Soft-Tissue SarcomasPhase 3SUCCEEDNCT00538239
Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)
A Phase 3 study testing ridaforolimus in people with Metastatic Soft-Tissue Sarcomas and Metastatic Bone Sarcomas, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Metastatic Soft-Tissue Sarcomas, Metastatic Bone Sarcomas
- What is being tested?
- ridaforolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Dec 2012
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
- Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
- Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
Who cannot join
- Prior therapy with rapamycin or rapamycin analogs
- Ongoing toxicity associated with prior anticancer therapy
- Another primary malignancy within the past three years
- Concomitant medications that induce or inhibit CYP3A
- Significant, uncontrolled cardiovascular disease
About this study
Official title: A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas
The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.
- Being tested
- ridaforolimus, Placebo
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimusDrug
Also called deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
Four 10 mg tablets taken by mouth for 5 days per week continuously
PlaceboDrug
Four 10 mg tablets taken by mouth for 5 days per week continuously
| Study group | Role | What they receive |
|---|---|---|
| Ridaforolimus | Experimental | Not described Receives: Drug: ridaforolimus |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: Up to 157 weeks after randomization
Secondary outcomes (5)
Overall survival: First Analysis
Measured: Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)
Measured: Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011
Measured: Up to 184 weeks after randomization
Overall Survival: Updated Analysis as of 21 January 2012
Measured: Up to 222 weeks after randomization
Safety and tolerability
Measured: Up to 157 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionDec 2012
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 Metastatic Soft-Tissue SarcomasStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 711 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
- NCT00538239
- Sponsor's protocol ID
- 8669-011
- Other IDs
- AP23573-07-302
- Acronym
- SUCCEED
- Status last verified
- Feb 2015
- First submitted
- 28 Sep 2007
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.
PubMed 23715582
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 Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas
- ClinicalTrials.gov ID
- NCT00538239
- Acronym / sponsor ID
- SUCCEED / 8669-011
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Oct 2007 (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 determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ridaforolimus | Experimental | Drug: ridaforolimus |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
- Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
- Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
Key exclusion criteria (5 listed)
- Prior therapy with rapamycin or rapamycin analogs
- Ongoing toxicity associated with prior anticancer therapy
- Another primary malignancy within the past three years
- Concomitant medications that induce or inhibit CYP3A
- Significant, uncontrolled cardiovascular disease
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, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009Four 10 mg tablets taken by mouth for 5 days per week continuously | Drug | Ridaforolimus |
| PlaceboFour 10 mg tablets taken by mouth for 5 days per week continuously | Drug | Placebo |
Primary outcome
Progression-free Survival
Time frame: Up to 157 weeks after randomization
5 secondary outcomes
Overall survival: First Analysis
Time frame: Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)
Time frame: Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011
Time frame: Up to 184 weeks after randomization
Overall Survival: Updated Analysis as of 21 January 2012
Time frame: Up to 222 weeks after randomization
Safety and tolerability
Time frame: Up to 157 weeks after randomization
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 23715582Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.
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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 3 study testing ridaforolimus in people with Metastatic Soft-Tissue Sarcomas and Metastatic Bone Sarcomas, 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 5 inclusion and 5 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free Survival (time frame: Up to 157 weeks after randomization). 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 NCT00538239, 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.