Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)

A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010672

Enrollment

Registered

2009-11-10

Start date

2009-11-30

Completion date

2013-01-31

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Brief summary

The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.

Interventions

DRUGRidaforolimus

Ridaforolimus, oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week. Participants treated until discontinuation criteria, such as progressive disease or unacceptable toxicity, were met.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization * Adequate organ and bone marrow function

Exclusion criteria

* Presence of brain or central nervous system (CNS) metastases, unless successfully treated * Prior therapy with rapamycin or rapamycin analogs * Ongoing toxicity associated with prior anticancer therapy * History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient

Design outcomes

Primary

Measure	Time frame	Description
Progression free rate (PFR) at 6 months	6 months	Progression free rate at 6 months is defined as the proportion of participants who are a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions) or stable disease (does not qualify for PR or progressive disease) at 6 months from the date of the first study drug administration.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026