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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00538239

Acronym

SUCCEED

Enrollment

711

Registered

2007-10-02

Start date

2007-10-31

Completion date

2012-12-31

Last updated

2015-02-13

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

Conditions

Metastatic Bone Sarcomas, Metastatic Soft-Tissue Sarcomas

Brief 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.

Interventions

DRUGridaforolimus

Four 10 mg tablets taken by mouth for 5 days per week continuously

DRUGPlacebo

Four 10 mg tablets taken by mouth for 5 days per week continuously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free Survival	Up to 157 weeks after randomization

Secondary

Measure	Time frame
Overall survival: First Analysis	Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)	Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011	Up to 184 weeks after randomization
Overall Survival: Updated Analysis as of 21 January 2012	Up to 222 weeks after randomization
Safety and tolerability	Up to 157 weeks after randomization

Outcome results

None listed

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