Phase 2
N=36
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00630344 ↗Enrolled (actual)
36
Serious AEs
52.8%
Results posted
Mar 2014
Primary outcome: Primary: Overall Response Rate — 6 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RAD001 (Drug); Bicalutamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
6 | — |
| SECONDARY Incidence of Grade 4 Treatment-Related Toxicity |
— | — |
| SECONDARY Incidence of Grade 1-3 Treatment-Related Mucositis Toxicity |
20 | — |
| SECONDARY Incidence of Grade 1-3 Treatment-Related Rash Toxicity |
17 | — |
| SECONDARY Incidence of Grade 1-3 Treatment-Related Fatigue Toxicity |
16 | — |
| SECONDARY Time to Progression (TTP) |
8.7 | — |
Summary
In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative resistance. The goal of this study is to learn if the study drug RAD001 together with Bicalutamide can slow the growth of prostate cancer. The safety of the combination will also be studied.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Histologically documented prostate cancer
- Castration resistant prostate cancer defined as two rising PSAs on castration therapy
- Baseline PSA of 2ns/mL or greater
- Testosterone of 50ng/mL or less
- Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
- Prior bicalutamide is allowed as long as treatment was for 6 months or longer
- Metastatic disease is not required
- Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- ECOG Performance Status equal to or less than 2
- Adequate bone marrow and liver function as outlined by parameters in the protocol
Exclusion Criteria
- Prior treatment with any investigational drug within the preceding 4 weeks
- Prior treatment with an mTOR inhibitor
- Fasting lipids over the parameters outlined in the protocol
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
- Men able to conceive and unwilling to practice an effective method of birth control
- Known hypersensitivity to RAD001 or other rapamycins or to its excipients
- History of noncompliance to medical regimens
Data sourced from ClinicalTrials.gov (NCT00630344). 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.