A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
This study is currently recruiting participants.
Verified May 2013 by Sarcoma Alliance for Research through Collaboration
Sponsor:
Sarcoma Alliance for Research through Collaboration
Collaborator:
AstraZeneca
Information provided by:
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT00752206
First received: September 11, 2008
Last updated: May 28, 2013
Last verified: May 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752206
Contacts
| Contact: Denise Reinke, MS, NP, President | 734-930-7600 | sarc@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 | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Lakshmi Damerla, PA-C & CCTI 323-361-8359 ldamerla@chla.usc.edu | |
| Principal Investigator: Leo Mascarenhas, MD, MS | |
| 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 | |
| USC/Norris Comprehensive Cancer Center and Hospital | Not yet recruiting |
| Los Angeles, California, United States, 90089 | |
| Principal Investigator: James Hu, 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 Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Ashley Bayne, RN 352-265-0027 abayne@ufl.edu | |
| Principal Investigator: Joanne P. Lagmay, MD | |
| 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 | Terminated |
| Indianapolis, Indiana, United States, 46202 | |
| 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: Kristin Baird, 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 | Active, not recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| 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: | 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: | May 28, 2013 |
| 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 June 18, 2013