1 and older, any sex, with Advanced Cancers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced an Adverse EventPrimary· 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.
Group
Value
95% CI
Ridaforolimus 10 mg Days 1-5
3
Ridaforolimus 10 mg Days 1-6
1
Ridaforolimus 20 mg Days 1-5
1
Ridaforolimus 30 mg Days 1-5
1
Ridaforolimus 40 mg Days 1-5
1
Progression-free Survival (PFS)Secondary· 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.
Group
Value
95% CI
Ridaforolimus 10 mg Days 1-5
488.67
78 – 1297
Ridaforolimus 10 mg Days 1-6
2858
2858 – 2858
Ridaforolimus 20 mg Days 1-5
2936
2936 – 2936
Ridaforolimus 30 mg Days 1-5
1142
1142 – 1142
Ridaforolimus 40 mg Days 1-5
29
29 – 29
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Ridaforolimus 10 mg Days 1-5
1803.67
1067 – 2451
Ridaforolimus 10 mg Days 1-6
2933
2933 – 2933
Ridaforolimus 20 mg Days 1-5
2962
2962 – 2962
Ridaforolimus 30 mg Days 1-5
2334
2334 – 2334
Ridaforolimus 40 mg Days 1-5
247
247 – 247
Number of Participants Who Discontinued Study Drug Due to an Adverse EventPrimary· 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.
Group
Value
95% CI
Ridaforolimus 10 mg Days 1-5
0
Ridaforolimus 10 mg Days 1-6
0
Ridaforolimus 20 mg Days 1-5
0
Ridaforolimus 30 mg Days 1-5
0
Ridaforolimus 40 mg Days 1-5
0
Duration of Response (DOR)Secondary· 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.
Group
Value
95% CI
Ridaforolimus 20 mg Days 1-5
2894
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected in the study database for up to approximately 2991 days (including 30 days after the last dose as of data cut-off date 03 Apr 2017). Following closure of the database through 04 Feb 2018 (approximately 307 days), only serious adverse events were collected..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 18 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00836927.