NCT00752206

A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-over, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung

Terminated Phase 2 Results posted Last updated 7 January 2020

What this trial tests

Phase 2 trial testing Saracatinib in Osteosarcoma in 38 participants. Terminated before completion.

Timeline

1 March 2009

Primary endpoint
1 August 2017

1 December 2017

Quick facts

Lead sponsor	Sarcoma Alliance for Research through Collaboration
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	1 March 2009
Primary completion	1 August 2017
Estimated completion	1 December 2017
Sites	18 locations across United States

Drugs / interventions tested

• Saracatinib — full drug profile →
• Placebo

Conditions studied

• Osteosarcoma — all drugs for Osteosarcoma →

Sponsor

Sarcoma Alliance for Research through Collaboration — full company profile →

Who can join

Adults 15 to 74, any sex, with Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.
  Time frame: Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment.
  To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.

Sponsor's own description

The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Osteoporosis: now and the future.
   Rachner TD, Khosla S, Hofbauer LC. · · 2011 · cited 1916× · PMID 21450337 · DOI 10.1016/s0140-6736(10)62349-5
2. Current therapeutic strategies and novel approaches in osteosarcoma.
   Ando K, Heymann MF, Stresing V, Mori K, et al · · 2013 · cited 166× · PMID 24216993 · DOI 10.3390/cancers5020591
3. Unraveling the complexity of STAT3 in cancer: molecular understanding and drug discovery.
   Hu Y, Dong Z, Liu K. · · 2024 · cited 159× · PMID 38245798 · DOI 10.1186/s13046-024-02949-5
4. Molecular alterations as target for therapy in metastatic osteosarcoma: a review of literature.
   PosthumaDeBoer J, Witlox MA, Kaspers GJ, van Royen BJ. · · 2011 · cited 153× · PMID 21461590 · DOI 10.1007/s10585-011-9384-x
5. Epidemiology and therapies for metastatic sarcoma.
   Amankwah EK, Conley AP, Reed DR. · · 2013 · cited 126× · PMID 23700373 · DOI 10.2147/clep.s28390
6. Osteosarcoma Genetics and Epigenetics: Emerging Biology and Candidate Therapies.
   Morrow JJ, Khanna C. · · 2015 · cited 124× · PMID 26349415 · DOI 10.1615/critrevoncog.2015013713
7. Present Advances and Future Perspectives of Molecular Targeted Therapy for Osteosarcoma.
   Shaikh AB, Li F, Li M, He B, et al · · 2016 · cited 89× · PMID 27058531 · DOI 10.3390/ijms17040506
8. Tyrosine Kinase Receptors in Oncology.
   Esteban-Villarrubia J, Soto-Castillo JJ, Pozas J, San Román-Gil M, et al · · 2020 · cited 72× · PMID 33198314 · DOI 10.3390/ijms21228529