Adults 18 to 75, any sex, with Cancer, Advanced. 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 Experiencing Clinical and Laboratory Adverse Events (AEs)Secondary· From first dose up to 30 days after last dose (Up to 26 weeks)
A laboratory AE (LAE) is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE (CAE) is defined similarly but also includes changes in structure or function of the body. Serious AEs (SAEs) are those that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinica
Clinical & Laboratory AEs
Group
Value
95% CI
Ridaforolimus 40 mg
15
Drug-related AEs
Group
Value
95% CI
Ridaforolimus 40 mg
15
Serious AEs (SAEs)
Group
Value
95% CI
Ridaforolimus 40 mg
4
Lag Time (Tlag) of Ridaforolimus: Day 1Primary· Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 is 19 days
Tlag is the time taken for ridaforolimus to appear in systemic circulation following oral administration. The median and full range (minimum, maximum) for Tlag after a single dose of ridafolorlimus are presented.
Group
Value
95% CI
Ridaforolimus 40 mg
2.00
0.97 – 8.07
Area Under the Curve From 0 to Infinity (AUC0-∞) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)Primary· Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 days
AUC0-∞ represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to infinity) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric mean and back-transformed 95% confidence interval are presented for AUC0-∞.
Group
Value
95% CI
Ridaforolimus 40 mg
3648
3044 – 4372
Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Ridaforolimus: Day 1, Day 19Primary· Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days
AUC0-24hr represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to 24 hours) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple d
Day 1
Group
Value
95% CI
Ridaforolimus 40 mg
1846
1361 – 2503
Day 19
Group
Value
95% CI
Ridaforolimus 40 mg
2014
1485 – 2731
Maximum Concentration (Cmax) of Ridaforolimus: Day 1, Day 19Primary· Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days
Cmax is the peak blood plasma concentration following a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for Cmax.
Day 1
Group
Value
95% CI
Ridaforolimus 40 mg
210
150 – 295
Day 19
Group
Value
95% CI
Ridaforolimus 40 mg
167
119 – 234
Concentration at 24 Hours (C24hr) of Ridaforolimus: Day 1, Day 19Primary· Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days
C24hr is the concentration of ridaforolimus in the blood 24 hours after a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for C24hr.
Day 1
Group
Value
95% CI
Ridaforolimus 40 mg
34.8
26.0 – 46.8
Day 19
Group
Value
95% CI
Ridaforolimus 40 mg
49.7
36.4 – 67.7
Time to Maximum Concentration (Tmax) of Ridaforolimus: Day 1, Day 19Primary· Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days
Tmax is the time at which the Cmax of ridaforolimus is reached. The medians and ranges (minimum, maximum) for Tmax after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.
Day 1
Group
Value
95% CI
Ridaforolimus 40 mg
4.03
2.00 – 7.97
Day 19
Group
Value
95% CI
Ridaforolimus 40 mg
4.00
0.00 – 6.00
Apparent Terminal Half-life (t1/2) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)Primary· Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 days
t½ is the time that it takes for the concentration of ridaforolimus in the body to decrease by half. The (harmonic) means and 95% confidence intervals for t1/2 after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.
Group
Value
95% CI
Ridaforolimus 40 mg
52.9
40.2 – 65.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose up to 30 days after last dose (Up to 26 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ridaforolimus 40 mg
Serious: 4/15 (27%)
Deaths: 3/15
Serious adverse events (3 terms)
Reaction
System
Ridaforolimus 40 mg
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Disease progression
General disorders
—
Tracheal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of ridaforolimus (MK-8669) after administration of single and multiple 40 mg doses in Chinese participants with advanced cancer. Part 2 of the study is optional; participants can continue to receive the study treatment in a weekly regimen of daily oral doses of ridaforolimus 40 mg for five consecutive days followed by two days off-treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01243762 — A Study of Dalotuzumab + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + Ridaforolimus Combination Therapies in Partic
· Phase 1
· terminated
NCT01234857 — A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in E
· Phase 2
· completed
NCT00770185 — Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
· Phase 2
· completed
Other recruiting trials for Cancer, Advanced
Currently open trials in the same condition.
NCT03383094 — Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer
· Phase 2
· active not recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 19 April 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/NCT01380184.