Trial record 1 of 1 for:    nct00752206
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A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT00752206
First received: September 11, 2008
Last updated: July 16, 2014
Last verified: July 2014
  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 2

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, Cross-over, 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:


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.

Patients who recur in the lung while on-study and who are thought to be amenable to complete surgical resection will be able to find out if they were receiving placebo or saracatinib. Those patients who were receiving placebo may then have the option of undergoing surgical resection. If fully resected of all recurrent disease,they will be given the option of receiving oral therapy with saracatinib. Saracatinib will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with saracatinib will be thirteen 28-day cycles (364 days total). If complete resection of all lung nodules is not achieved, the patient will be removed from the study.

Patients who recur in locations other than the lung while on-study will be taken off study at that time.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
UCLA/Mattel's Children's Hospital
Los Angeles, California, United States, 90095
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Stanford University
Palo Alto, California, United States, 94304
UCSF
San Francisco, California, United States, 94143
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Miami
Miami, Florida, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48106
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Washington
Seattle Cancer Care Alliance/University of Washington Medical Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
AstraZeneca
Investigators
Principal Investigator: Kristin Baird, MD National Cancer Institute - Pediatric Oncology Branch
  More Information

Additional Information:
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: July 16, 2014
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
Saracatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014