Advanced CancersPhase 2NCT00836927
Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)
A Phase 2 study testing Ridaforolimus Tablet and Ridaforolimus Intravenous (IV) Infusion in people with Advanced Cancers, run by Merck Sharp & Dohme LLC.
Trial summary
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Ridaforolimus Tablet and Ridaforolimus Intravenous (IV) Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2009to 4 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have participated on a deforolimus (ridaforolimus) parent trial
- Must have derived a clinical benefit from the parent trial
- Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
- Participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
- Signed informed consent
Who cannot join
- Has not participated on a parent trial
- Women who are to receive study drug who are pregnant or lactating
- Any condition in the Investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol
About this study
Official title: An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.
- Conditions
- Advanced Cancers
- Being tested
- Ridaforolimus Tablet, Ridaforolimus Intravenous (IV) Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridaforolimus TabletDrug
Also called AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
Ridaforolimus 10 mg oral tablet
Ridaforolimus Intravenous (IV) InfusionDrug
Also called AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
| Study group | Role | What they receive |
|---|---|---|
| Ridaforolimus 10 mg Days 1-5 | Experimental | Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus intravenous (IV) infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. Receives: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion |
| Ridaforolimus 10 mg Days 1-6 | Experimental | Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. Receives: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion |
| Ridaforolimus 20 mg Days 1-5 | Experimental | Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. Receives: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion |
| Ridaforolimus 30 mg Days 1-5 | Experimental | Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. Receives: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion |
| Ridaforolimus 40 mg Days 1-5 | Experimental | Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. Receives: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.
Measured: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.
Measured: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Secondary outcomes (3)
Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD), or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS for all participants is presented in days.
Measured: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up.
Measured: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)
Duration of Response (DOR)
For participants who demonstrated a confirmed response (Completed Response [CR] or Partial Response [PR]) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.
Measured: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study start1 Feb 2009
- Primary completion3 Apr 2017
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836927
- Sponsor's protocol ID
- 8669-038
- Other IDs
- AP23573-08-901, MK-8669-038
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2009
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00836927
- Acronym / sponsor ID
- 8669-038
- Conditions
- Advanced Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ridaforolimus 10 mg Days 1-5 | Experimental | Drug: Ridaforolimus Tablet, Drug: Ridaforolimus Intravenous (IV) InfusionRidaforolimus 10 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus intravenous (IV) infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. |
| Ridaforolimus 10 mg Days 1-6 | Experimental | Drug: Ridaforolimus Tablet, Drug: Ridaforolimus Intravenous (IV) InfusionRidaforolimus 10 mg administered orally once daily on Days 1-6 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. |
| Ridaforolimus 20 mg Days 1-5 | Experimental | Drug: Ridaforolimus Tablet, Drug: Ridaforolimus Intravenous (IV) InfusionRidaforolimus 20 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. |
| Ridaforolimus 30 mg Days 1-5 | Experimental | Drug: Ridaforolimus Tablet, Drug: Ridaforolimus Intravenous (IV) InfusionRidaforolimus 30 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. |
| Ridaforolimus 40 mg Days 1-5 | Experimental | Drug: Ridaforolimus Tablet, Drug: Ridaforolimus Intravenous (IV) InfusionRidaforolimus 40 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Must have participated on a deforolimus (ridaforolimus) parent trial
- Must have derived a clinical benefit from the parent trial
- Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
- Participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
Key exclusion criteria (3 listed)
- Has not participated on a parent trial
- Women who are to receive study drug who are pregnant or lactating
- Any condition in the Investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol
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 |
|---|---|---|
| Ridaforolimus TabletAlso: AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009Ridaforolimus 10 mg oral tablet | Drug | Ridaforolimus 10 mg Days 1-5, Ridaforolimus 10 mg Days 1-6, Ridaforolimus 20 mg Days 1-5, Ridaforolimus 30 mg Days 1-5, Ridaforolimus 40 mg Days 1-5 |
| Ridaforolimus Intravenous (IV) InfusionAlso: AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle). | Drug | Ridaforolimus 10 mg Days 1-5, Ridaforolimus 10 mg Days 1-6, Ridaforolimus 20 mg Days 1-5, Ridaforolimus 30 mg Days 1-5, Ridaforolimus 40 mg Days 1-5 |
Primary outcome
Number of Participants Who Experienced an Adverse Event
Time frame: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.
3 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Overall Survival (OS)
Time frame: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)
Duration of Response (DOR)
Time frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ridaforolimus Tablet and Ridaforolimus Intravenous (IV) Infusion in people with Advanced Cancers, 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 3 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Who Experienced an Adverse Event (time frame: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)). The study lists 2 primary outcomes in all. 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 18 Feb 2019.