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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010672
• Other study ID #: 8669-030
• Secondary ID: 2009_688MK-8669-
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2009
• Last updated: April 29, 2015
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• Ridaforolimus
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free rate (PFR) at 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.	6 months	No