Phase 2
Completed N=19
The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
Metastatic, Androgen Independent Prostate Cancer · Prostate Cancer
Source: ClinicalTrials.gov NCT00459186 ↗
Enrolled (actual)
19
Serious AEs
72.2%
Results posted
Mar 2014
Primary outcomePrimary: Number of Patients Free of Dose Limiting Toxicity — 14 participants
Summary
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).
Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Free of Dose Limiting Toxicity |
14 | — |
| SECONDARY Response Based on PET Scan |
22; 67; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Adenocarcinoma of the prostate with radiographic evidence of metastatic disease.
- Willingness to undergo a baseline tumor biopsy.
- Castrate levels of testosterone (testosterone 1, 500/\_l; platelets > 100,000/\_l; total Bilirubin < upper limit of normal; AST and ALT < 3 x upper limits of normal; creatinine < 1.5 x upper limits of normal; total fasting cholesterol < 350 mg/dl; total triglycerides < 300 mg/dl
Exclusion Criteria
- Ongoing oral steroid use. Patients with a history of oral steroid use are eligible as long as the steroids have been discontinued prior to study entry. Ongoing topical and/or inhaled steroid use is allowed.
- Prior taxane chemotherapy
- Prior mTOR inhibitors (RAD001, rapamycin, CCI-779)
- Currently active second malignancy other than non-melanoma skin cancer.
- Ongoing peripheral neuropathy of Grade 2
Data sourced from ClinicalTrials.gov (NCT00459186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.