Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation
| Group | Value |
|---|---|
| Everolimus With Combined Hormonal and Radiation Therapy | not posted |
Trial · Interventional
TerminatedPhase 1Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Lack of accrual and funding expires in June, 2014.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer
NCT01642732Oct 2012 to Aug 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purposes of this study are to: * Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be taken in combination with hormonal and radiation therapy in men with high risk prostate cancer. * Evaluate changes in patient reported quality of life * Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor. Biomarkers can also help determine areas for further research.
Experimental
Everolimus with combined hormonal and radiation therapy
Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1. Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks). Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy. Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections. Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study.
Outcomes the sponsor listed as primary.
Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation
Time frame · 64 months after beginning everolimus
Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus
Time frame · Prior to treatment and at 14 days
Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Everolimus With Combined Hormonal and Radiation Therapy | not posted |
| Group | Value |
|---|---|
| Everolimus With Combined Hormonal and Radiation Therapy | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Everolimus With Combined Hormonal and Radiation TherapyEverolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1. Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks). Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy. Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections. Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study. | – | 0 / 0 | 0 / 0 |
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