NCT00538239

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
711

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

September 28, 2007

Last Update Submit

February 12, 2015

Conditions

Metastatic Soft-Tissue SarcomasMetastatic Bone Sarcomas

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    Up to 157 weeks after randomization

Secondary Outcomes (5)

  • 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

Study Arms (2)

Ridaforolimus

EXPERIMENTAL
Drug: ridaforolimus

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ridaforolimusDRUG

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

Also known as: deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009
Ridaforolimus
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.

    PMID: 23715582RESULT

MeSH Terms

Conditions

SarcomaBone Neoplasms

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 2, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2012

Last Updated

February 13, 2015

Record last verified: 2015-02