NCT00574769

Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer

Completed Phase 1, PHASE2 Last updated 11 April 2017

What this trial tests

Phase 1, PHASE2 trial testing RAD001, Docetaxel, Bevacizumab in Prostate Cancer in 27 participants. Completed in 17 February 2017.

Timeline

17 February 2010

Primary endpoint
17 February 2016

17 February 2017

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	17 February 2010
Primary completion	17 February 2016
Estimated completion	17 February 2017
Sites	2 locations across United States

Drugs / interventions tested

• RAD001, Docetaxel, Bevacizumab — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Southern California

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapy for advanced prostate cancer: inhibition of the PI3K/Akt/mTOR pathway.
   Morgan TM, Koreckij TD, Corey E. · · 2009 · cited 214× · PMID 19275762 · DOI 10.2174/156800909787580999
2. Therapeutic targeting of autophagy in disease: biology and pharmacology.
   Cheng Y, Ren X, Hait WN, Yang JM. · · 2013 · cited 188× · PMID 23943849 · DOI 10.1124/pr.112.007120
3. Recent Advances in Prostate Cancer Treatment and Drug Discovery.
   Nevedomskaya E, Baumgart SJ, Haendler B. · · 2018 · cited 176× · PMID 29734647 · DOI 10.3390/ijms19051359
4. Role of PI3K-AKT-mTOR Pathway as a Pro-Survival Signaling and Resistance-Mediating Mechanism to Therapy of Prostate Cancer.
   Pungsrinont T, Kallenbach J, Baniahmad A. · · 2021 · cited 148× · PMID 34681745 · DOI 10.3390/ijms222011088
5. Rapid phenotypic and genomic change in response to therapeutic pressure in prostate cancer inferred by high content analysis of single circulating tumor cells.
   Dago AE, Stepansky A, Carlsson A, Luttgen M, et al · · 2014 · cited 123× · PMID 25084170 · DOI 10.1371/journal.pone.0101777
6. AR and PI3K/AKT in Prostate Cancer: A Tale of Two Interconnected Pathways.
   Tortorella E, Giantulli S, Sciarra A, Silvestri I. · · 2023 · cited 52× · PMID 36768370 · DOI 10.3390/ijms24032046
7. Autophagy: A challengeable paradox in cancer treatment.
   Ahmadi-Dehlaghi F, Mohammadi P, Valipour E, Pournaghi P, et al · · 2023 · cited 50× · PMID 36760166 · DOI 10.1002/cam4.5577
8. Recent progress in pharmaceutical therapies for castration-resistant prostate cancer.
   Yin L, Hu Q, Hartmann RW. · · 2013 · cited 35× · PMID 23880851 · DOI 10.3390/ijms140713958