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

Phase 2

Terminated

• Conditions: Advanced Cancers
• Interventions: Drug: Ridaforolimus Tablet; Drug: Ridaforolimus Intravenous (IV) Infusion

• Registration Number: NCT00836927
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-01
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2017-04-03
• Study Completion: 2018-02-04
• Results First Submitted: 2018-04-03
• Results First Submitted QC: 2018-04-03
• Results First Posted: 2018-05-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ridaforolimus 20 mg Days 1-5	Ridaforolimus Intravenous (IV) Infusion	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.
Ridaforolimus 30 mg Days 1-5	Ridaforolimus Tablet	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.
Ridaforolimus 10 mg Days 1-6	Ridaforolimus Tablet	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.
Ridaforolimus 10 mg Days 1-6	Ridaforolimus Intravenous (IV) Infusion	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.
Ridaforolimus 20 mg Days 1-5	Ridaforolimus Tablet	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.
Ridaforolimus 10 mg Days 1-5	Ridaforolimus Tablet	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.
Ridaforolimus 10 mg Days 1-5	Ridaforolimus Intravenous (IV) Infusion	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.
Ridaforolimus 30 mg Days 1-5	Ridaforolimus Intravenous (IV) Infusion	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.
Ridaforolimus 40 mg Days 1-5	Ridaforolimus Tablet	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.
Ridaforolimus 40 mg Days 1-5	Ridaforolimus Intravenous (IV) Infusion	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced an Adverse Event	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	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)	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.
Progression-free Survival (PFS)	Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)	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.
Overall Survival (OS)	Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)	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.