Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)

Study Overview
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Brief Summary
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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.

Official Title
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An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer

Conditions
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Advanced Cancers

Intervention / Treatment
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* Drug: Ridaforolimus Tablet
* Drug: Ridaforolimus Intravenous (IV) Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ridaforolimus 10 mg Days 1-5<br>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. | Drug: Ridaforolimus Tablet<br>* Ridaforolimus 10 mg oral tablet<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;Drug: Ridaforolimus Intravenous (IV) Infusion<br>* Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|
| Experimental: Ridaforolimus 10 mg Days 1-6<br>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. | Drug: Ridaforolimus Tablet<br>* Ridaforolimus 10 mg oral tablet<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;Drug: Ridaforolimus Intravenous (IV) Infusion<br>* Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|
| Experimental: Ridaforolimus 20 mg Days 1-5<br>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. | Drug: Ridaforolimus Tablet<br>* Ridaforolimus 10 mg oral tablet<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;Drug: Ridaforolimus Intravenous (IV) Infusion<br>* Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|
| Experimental: Ridaforolimus 30 mg Days 1-5<br>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. | Drug: Ridaforolimus Tablet<br>* Ridaforolimus 10 mg oral tablet<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;Drug: Ridaforolimus Intravenous (IV) Infusion<br>* Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|
| Experimental: Ridaforolimus 40 mg Days 1-5<br>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. | Drug: Ridaforolimus Tablet<br>* Ridaforolimus 10 mg oral tablet<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;Drug: Ridaforolimus Intravenous (IV) Infusion<br>* Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).<br>* Other names: ridaforolimus was also known as deforolimus until May 2009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) |