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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Cancers
• Intervention / Treatment: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ridaforolimus 10 mg Days 1-5; 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; Ridaforolimus 10 mg oral tablet; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; Drug: Ridaforolimus Intravenous (IV) Infusion; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 10 mg Days 1-6; 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; Ridaforolimus 10 mg oral tablet; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; Drug: Ridaforolimus Intravenous (IV) Infusion; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 20 mg Days 1-5; 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; Ridaforolimus 10 mg oral tablet; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; Drug: Ridaforolimus Intravenous (IV) Infusion; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 30 mg Days 1-5; 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; Ridaforolimus 10 mg oral tablet; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; Drug: Ridaforolimus Intravenous (IV) Infusion; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 40 mg Days 1-5; 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; Ridaforolimus 10 mg oral tablet; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; Drug: Ridaforolimus Intravenous (IV) Infusion; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).; Other Names: AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Ariad Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): April 3, 2017
• Study Completion (Actual): February 4, 2018

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 8669-038; AP23573-08-901 (Other Identifier: Ariad Protocol Number); MK-8669-038 (Other Identifier: Merck Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No