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

NCT ID: NCT00752206

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2017-12-31

Brief Summary

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).

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.

Conditions

Osteosarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 13 cycles.

Group Type: ACTIVE_COMPARATOR

Saracatinib

Intervention Type: DRUG

Oral Agent

Placebo

Placebo 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 placebo will be 13 cycles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Agent

Interventions

Saracatinib

Oral Agent

Intervention Type: DRUG

Placebo

Oral Agent

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Sarcoma Alliance for Research through Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Baird, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute - Pediatric Oncology Branch

Locations

University of Alabama

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

UCLA/Mattel's Children's Hospital

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

UCSF

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

National Cancer Institute

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Seattle Cancer Care Alliance/University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.sarctrials.org

Related Info

Other Identifiers

D8180C00039

Identifier Type: -

Identifier Source: secondary_id

SARC012

Identifier Type: -

Identifier Source: org_study_id

NCT00923286

Identifier Type: -

Identifier Source: nct_alias