A Phase 2 interventional study of Saracatinib and Placebo in Osteosarcoma, sponsored by Sarcoma Alliance for Research through Collaboration. Terminated at 18 sites in United States. Open to participants aged 15 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Sarcoma Alliance for Research through Collaboration · Phase 2, Interventional, and Treatment
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).
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.
446 studies on the registry are indexed under Osteosarcoma; 117 are open to participants now.
This study's enrollment of 38 is close to the median of 41 across 330 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Sarcoma Alliance for Research through Collaboration is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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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 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
Oral Agent
Oral Agent
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.
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.
Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival.
Time frame: 5 year overall survival
Change in Time to Treatment Failure With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation.
Time frame: Up to 12 months
Number of Genes Identified for Prediction of Recurrence of Osteosarcoma
To perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes.
Time frame: Up to 12 months
Biomarkers Related to Activation of Src and Src Substrates
To evaluate tumor samples for biomarkers related to activation of Src and Src substrates.
Time frame: Up to 12 months
Cell Lines and Murine Xenografts From Recurrent Tumor Samples
To establish cell lines and murine xenografts from recurrent tumor samples.
Time frame: Up to 12 months
Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma
To perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor.
Time frame: Up to 12 months
| Milestone | Saracatinib | Placebo |
|---|---|---|
| Started | 19 | 19 |
| Completed | 10 | 8 |
| Not completed | 9 | 11 |
| Withdrew: Disease progression | 8 | 11 |
| Withdrew: Pregnancy | 1 | 0 |
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.
| months | Saracatinib | Placebo |
|---|---|---|
| Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo. | 19.4 (0 to 60) | 8.6 (0 to 60) |
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival.
| months | Saracatinib | Placebo |
|---|---|---|
| Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy | NA (45 to 70) | NA (45 to 70) |
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation.
No measurements were reported for this outcome.
To perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes.
| identified genes | Saracatinib | Placebo |
|---|---|---|
| Number of Genes Identified for Prediction of Recurrence of Osteosarcoma | 0 | 0 |
To evaluate tumor samples for biomarkers related to activation of Src and Src substrates.
No measurements were reported for this outcome.
To establish cell lines and murine xenografts from recurrent tumor samples.
No measurements were reported for this outcome.
To perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor.
| identified mutations | Saracatinib | Placebo |
|---|---|---|
| Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma | 0 | 0 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saracatinib | 0/18 (0%) | 3/18 (16.7%) | 18/37 (48.6%) |
| Placebo | 0/19 (0%) | 2/19 (10.5%) | 19/37 (51.4%) |
| Event | Saracatinib | Placebo |
|---|---|---|
| Lung NodulesRespiratory, thoracic and mediastinal disorders | 1/18 | 0/19 |
| Glioblastoma MultiformeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/18 | 0/19 |
| Brain MassNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/18 | 0/19 |
| PharyngitisInfections and infestations | 0/18 | 1/19 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/18 | 1/19 |
| Event | Saracatinib | Placebo |
|---|---|---|
| HypophosphatemiaMetabolism and nutrition disorders | 7/18 | 7/19 |
| DiarrheaGastrointestinal disorders | 6/18 | 4/19 |
| NauseaGastrointestinal disorders | 6/18 | 3/19 |
| Aspartate aminotransferase increasedInvestigations | 5/18 | 2/19 |
| HyperglycemiaMetabolism and nutrition disorders | 5/18 | 4/19 |
| LeukopeniaInvestigations | 5/18 | 2/19 |
| FatigueGeneral disorders | 4/18 | 5/19 |
| HeadacheNervous system disorders | 3/18 | 5/19 |
| Alkaline Phosphatase increasedInvestigations | 4/18 | 3/19 |
| ThrombocytopeniaInvestigations | 4/18 | 3/19 |
38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
| Age, Customized(years) | Saracatinib | Placebo | Total |
|---|---|---|---|
| Age | 23.89 ± 8.53 | 26.63 ± 12.07 | 25.30 ± 10.45 |
| Sex: Female, Male(Participants) | Saracatinib | Placebo | Total |
|---|---|---|---|
| Female | 7 | 11 | 18 |
| Male | 11 | 8 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Saracatinib | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 12 | 14 | 26 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Saracatinib | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 10 | 14 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Histology types(Participants) | Saracatinib | Placebo | Total |
|---|---|---|---|
| Osteoblastic sub-type | 9 | 12 | 21 |
| Chondroblastic | 6 | 3 | 9 |
| Telangiectatic | 3 | 1 | 4 |
| Fibroblastic | 0 | 3 | 3 |
Documents are hosted by the registry — open the source record to download them.
Ran from Mar 2009 to primary completion in Aug 2017, 101 months.
Results were first posted in Jan 2020, 2 years 5 months after primary completion.
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Studies of the drug tested here: Saracatinib
Sarcoma Alliance for Research through Collaboration