A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung - Full Text View

Sponsor:	Sarcoma Alliance for Research through Collaboration
Collaborator:	AstraZeneca
Information provided by:	Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:	NCT00752206

Purpose

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).

Condition	Intervention	Phase
Osteosarcoma	Drug: Saracatinib Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: AZD0530

U.S. FDA Resources

Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:

To determine the 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Saracatinib Oral Agent
Placebo Comparator: 2	Drug: Placebo Oral Agent

Detailed Description:

Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):

After complete surgical removal of their cancer, patients will be randomly assigned to receive either Saracatinib or placebo (a sugar pill) throughout the study. Patients will take Saracatinib (or placebo) once daily by mouth for a total of 364 days. The duration of treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.

Patients will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6 months up to 2 years, and then every year up to 5 years after starting treatment. An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12 months.

Blood and tumor samples for research purposes will be collected at the time the tumor is removed.

After completing all 13 cycles, patients will be followed for approximately every 3 months until 2 years from starting treatment, then approximately every 6 months until 4 years from starting treatment, and once at year 5.

Eligibility

Ages Eligible for Study:	15 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient had recurrence of osteosarcoma, localized to the lungs, had complete surgical removal of all lung nodules are eligible for enrollment.
Patient with suspected recurrence of osteosarcoma but who has not had surgery is eligible for enrollment but will not be randomized to receive study medication until deemed fully eligible following surgical removal of all lung nodules.
Patient had histological confirmed diagnosis of osteosarcoma of the recurrent sample.
Patient had recurrence of osteosarcoma in the lung following standard therapy including: adriamycin, cisplatin, ifosfamide and methotrexate.
Patient is ≥ 15 and < 75 years of age.
Weight ≥ 34 kg.
ECOG performance score of 0-2.
Adequate bone marrow function.
Adequate renal function.
Adequate hepatic function.
Adequate cardiac function.
Women of childbearing potential must have had a negative pregnancy test (urine or serum) ≤ 7 days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for 3 months after the last dose.
Randomization must occur ≤ 6 weeks after complete surgical resection.
Patient or legal guardian has signed informed consent.

Exclusion Criteria:

Presence of metastatic disease in other locations in addition to the lung.
Disruption of the lung pleura by tumor.
Paget's disease.
Patient currently using, or has previously used CYP3A4 inducers or inhibitors within 2 to 14 days prior to the initiation of oral therapy.
Known hypersensitivity to other Src/Abl non-receptor kinase inhibitors.
Evidence of interstitial lung disease.
Any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Myocardial infarction within one year prior to study entry.
Bleeding diathesis, resulting in symptomatic bleeding.
Patient is pregnant or nursing/breast-feeding.
Patient received chemotherapy, biological or investigational agent ≤ 28 days prior to enrollment.
Patient experiencing unresolved toxicity ≥ CTCAE grade 2 (except alopecia) from previous agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752206

Contacts

Contact: Denise Reinke, MS, NP, President	734-930-7600	sarc@sarctrials.org
Contact: Ann Johnson, RN, CCRC	734-930-7600	ajohnson@sarctrials.org

Locations

United States, Alabama
University of Alabama	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Julia Adams 205-558-2984 jadams@peds.uab.edu
Principal Investigator: Joseph Pressey, MD
United States, California
UCLA/Mattel's Children's Hospital	Recruiting
Los Angeles, California, United States, 90095
Contact: LaMarr Taylor Smith, CCRP 310-794-8929 LaMarrTaylor@mednet.ucla.edu
Principal Investigator: Noah C. Federman, MD
Stanford University	Recruiting
Palo Alto, California, United States, 94304
Contact: Nadeem Mukhtar 650-497-8815 nmukhtar@stanford.edu
Principal Investigator: Neyssa Marina, MD
UCSF	Recruiting
San Francisco, California, United States, 94143
Contact: Shelly Allen AllenS@peds.ucsf.edu
Contact: Sharon Lee (415) 514-3658 leess@peds.ucsf.edu
Principal Investigator: Steven DuBois, MD
Sarcoma Oncology Center	Recruiting
Santa Monica, California, United States, 90403
Contact: Viky Chua 310-552-9999 vikychua@aol.com
Principal Investigator: Sant Chawla, MD
United States, Florida
University of Miami	Recruiting
Miami, Florida, United States
Contact: Myriam Zayas, RN 305-243-7846 mzayas2@med.miami.edu
Principal Investigator: John Goldberg, MD
United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristin Potter, MS 317-278-6616 krpotter@iupui.edu
Principal Investigator: Daniel Rushing, MD
United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Judy Swift, RN, MSN 319-356-8699 judy-swift@uiowa.edu
Principal Investigator: Mohammed Milhem, MD
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Adult Oncology 410-955-8804
Contact: Pediatric Oncology 410-955-8751
Principal Investigator: David Loeb, MD, PhD
National Cancer Institute	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Donna Bernstein, RN 301-435-7804 bernsted@mail.nih.gov
Contact: Lauren Long (301) 496-0486 longl@mail.nih.gov
Principal Investigator: Su Young Kim, MD
United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lynn Colicchio, RN 617-632-3989
Contact: Victoria Patterson, RN 617-582-7162
Principal Investigator: James E. Butrynski, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Gino Metko 734-647-2095 ginom@med.umich.edu
Principal Investigator: Scott Schuetze, MD, PhD
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Megan Westendorf 513-636-7810 megan.westendorf@cchmc.org
Contact: Kristina Kruskamp (513) 636-5336 Kristina.Kruskamp@cchmc.org
Principal Investigator: Lars M Wagner, M.D.
United States, Pennsylvania
Pennsylvania Hematology Oncology Associates	Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Deb Riordan, RN, BS 215-829-6712 debbieriordan@pennoncology.com
Principal Investigator: Arthur Staddon, MD
University of Pittsburgh Cancer Institute	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julia Irwin, RN, BSN, OCN 412-623-4036 neelyja@upmc.edu
Principal Investigator: Hussein Tawbi, MD
United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wendy Smith, RN 901-595-5120 Wendene.Smith@stjude.org
Principal Investigator: Sheri Spunt, MD
United States, Washington
Seattle Cancer Care Alliance/University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98109
Contact: Cristina Galer 206-667-5971 cgaler@seattlecca.org
Principal Investigator: Eve T. Rodler, MD

Sponsors and Collaborators

Sarcoma Alliance for Research through Collaboration

AstraZeneca

Investigators

Principal Investigator:

Su Y Kim, MD

National Cancer Institute - Pediatric Oncology Branch

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Denise Reinke, MS, NP / President, SARC (Sarcoma Alliance for Research through Collaboration)
ClinicalTrials.gov Identifier:	NCT00752206 History of Changes
Obsolete Identifiers:	NCT00923286
Other Study ID Numbers:	SARC012, D8180C00039
Study First Received:	September 11, 2008
Last Updated:	August 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarcoma Alliance for Research through Collaboration:

AZD0530
Saracatinib
Osteosarcoma

Recurrent
Localized
to the Lung

Additional relevant MeSH terms:

Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on February 09, 2012