Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

Metastatic Bone Sarcomas Clinical Trial

— SUCCEED  

Official title:

A Pivotal Trial to Determine the Efficacy and Safety of AP23573 When Administered as Maintenance Therapy to Patients With Metastatic Soft-Tissue or Bone Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538239
• Other study ID #: 8669-011
• Secondary ID: AP23573-07-302
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2007
• Last updated: February 12, 2015
• Start date: October 2007
• Est. completion date: December 2012

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: December 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of metastatic soft-tissue or bone sarcoma

• Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Adequate organ and bone marrow function

• Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization

Exclusion Criteria:

• Prior therapy with rapamycin or rapamycin analogs

• Ongoing toxicity associated with prior anticancer therapy

• Another primary malignancy within the past three years

• Concomitant medications that induce or inhibit CYP3A

• Significant, uncontrolled cardiovascular disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Bone Sarcomas
• Metastatic Soft-Tissue Sarcomas
• Osteosarcoma
• Sarcoma

Intervention

Drug:
• ridaforolimus
Four 10 mg tablets taken by mouth for 5 days per week continuously
• Placebo
Four 10 mg tablets taken by mouth for 5 days per week continuously

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

References & Publications (1)

Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Up to 157 weeks after randomization	No
Secondary	Overall survival: First Analysis		Up to 157 weeks after randomization	No
Secondary	Best Target Lesion Response (RECIST)		Up to 157 weeks after randomization	No
Secondary	Overall Survival: Updated Analysis as of 30 April 2011		Up to 184 weeks after randomization	No
Secondary	Overall Survival: Updated Analysis as of 21 January 2012		Up to 222 weeks after randomization	No
Secondary	Safety and tolerability		Up to 157 weeks after randomization	Yes