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
15 Years
74 Years
Both
Osteosarcoma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine the progression free survival rate among patients treated with Saracatinib and placebo.
Outcome 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.
Safety Issue:
Yes
Principal Investigator
Kristin Baird, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute - Pediatric Oncology Branch
Authority:
United States: Food and Drug Administration
Study ID:
SARC012
NCT ID:
NCT00752206
Start Date:
March 2009
Completion Date:
September 2014
Related Keywords:
- Osteosarcoma
- AZD0530
- Saracatinib
- Osteosarcoma
- Recurrent
- Localized
- to the Lung
- Osteosarcoma
Name | Location |
|---|---|
| University of Alabama | Birmingham, Alabama |
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
| UCSF | San Francisco, California 941430324 |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Stanford University | Stanford, California 94305 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| University of Florida | Gainesville, Florida 32610-0277 |
| University of Miami | Miami, Florida 33136 |
| Indiana University | Indianapolis, Indiana 46202 |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
| Sarcoma Oncology Center | Santa Monica, California 90403 |
| National Cancer Institute | Bethesda, Maryland 20892-1922 |
| UCLA/Mattel's Children's Hospital | Los Angeles, California 90095 |
| Pennsylvania Hematology Oncology Associates | Philadelphia, Pennsylvania 19106 |
| Seattle Cancer Care Alliance/University of Washington Medical Center | Seattle, Washington 98109 |
