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

NCT00752206 | Terminated Phase 2 Results DMC

• 2 other identifiers: SARC012D8180C00039
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 18

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).

Conditions

Osteosarcoma

Keywords

AZD0530; Saracatinib; Osteosarcoma; Recurrent; Localized; to the Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.

  To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.

  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.

Secondary Outcomes (6)

• Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy

  5 year overall survival

• Change in Time to Treatment Failure With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy

  Up to 12 months

• Number of Genes Identified for Prediction of Recurrence of Osteosarcoma

  Up to 12 months

• Biomarkers Related to Activation of Src and Src Substrates

  Up to 12 months

• Cell Lines and Murine Xenografts From Recurrent Tumor Samples

  Up to 12 months

Study Arms (2)

Saracatinib

ACTIVE COMPARATOR

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.

Drug: Saracatinib

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Saracatinib DRUG

Oral Agent

Saracatinib

Placebo DRUG

Oral Agent

Placebo

Eligibility Criteria

• Age: 15 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead
• AstraZeneca: collaborator

Study Sites (18)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

UCLA/Mattel's Children's Hospital

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Seattle Cancer Care Alliance/University of Washington Medical Center

Seattle, Washington, 98109, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteosarcoma; Recurrence

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: SARC
• Organization: SARC

sarc@sarctrials.org

(734) 930-7600

Study Officials

• Kristin Baird, MD

  National Cancer Institute - Pediatric Oncology Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: March 1, 2009
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2019-04

Locations

US (18)