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| ID | Type | Description | Link |
|---|---|---|---|
| AVF3955s | |||
| CRAD001CUS2468 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
Patients will undergo a screening procedure to determine eligibility of trial. During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study. The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits. These visits take place whenever the research medication is stopped, even if it is stopped early. For the patient's safety, he/she should at least complete the end of treatment visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001, Docetaxel, Bevacizumab | Drug | RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m^2 every 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab | After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer. | overall survival |
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Inclusion Criteria:
Age ≥ 18 years.
Signed informed consent
ECOG performance status: 0-2
Histologically documented adenocarcinoma of the prostate
Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following:
Measurable Disease: Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of one or more new lesions (Modified RECIST Criteria)
Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer
PSA Progression: An elevated PSA (≥ 5 ng/ml) which has risen serially from baseline on two occasions each at least one week apart
At least 4 weeks since any other hormonal therapy. Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks prior to initiating treatment. Bicalutamide or nilutamide must be discontinued at least 6 weeks prior to initiating treatment. If improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above. Androgen suppression should be continued
≥ 4 weeks since major surgery and fully recovered
≥ 8 weeks since high risk surgery and fully recovered
≥ 4 weeks since any prior radiation and fully recovered
≥ 6 weeks since the last dose of bone targeted radiopharmaceutical
Men of child-bearing potential are required to use an effective means of contraception
Required Initial Laboratory Values:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell E Gross, MD, Ph.D | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westside Prostate Cancer Center, University of Southern California | Beverly Hills | California | 90211 | United States | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 3, 2025 | |
| Reset | Oct 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 3, 2025 | Oct 17, 2025 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077143 | Docetaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D043823 |
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|
| USC/Norris Comprehensive Cancer Center |
| Los Angeles |
| California |
| 90033 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |