CLINICAL TRIALS PROFILE FOR PROVENGE

All Clinical Trials for PROVENGE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01385293 ↗	BKM120 in Metastatic Castration-resistant Prostate Cancer	Terminated	Novartis Pharmaceuticals	Phase 2	2011-08-01	The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.
NCT01385293 ↗	BKM120 in Metastatic Castration-resistant Prostate Cancer	Terminated	Andrew J. Armstrong, MD	Phase 2	2011-08-01	The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.
NCT01420965 ↗	Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer	Terminated	Augusta University	Phase 2	2012-09-01	Background: - Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment. Objectives: - To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer. Eligibility: - Men at least 18 years of age who have advanced prostate cancer. Design: - Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. - This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies. - Part I: - Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy. - Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T. - Participants will have Sipuleucel-T about 3 days after each cell donation. - Part II: - Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011. - Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I. - Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.
NCT01804465 ↗	Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer	Completed	Bristol-Myers Squibb	Phase 2	2014-04-22	The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.
NCT01804465 ↗	Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer	Completed	Dendreon	Phase 2	2014-04-22	The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.
NCT01804465 ↗	Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	2014-04-22	The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.
NCT01804465 ↗	Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer	Completed	University of California, San Francisco	Phase 2	2014-04-22	The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

Clinical Trial Conditions for PROVENGE

Condition Name

Condition Name for PROVENGE
Intervention	Trials
Prostate Cancer	9
Metastatic Castration-resistant Prostate Cancer	2
Stage IV Prostate Cancer	1
mCRPC	1

Condition MeSH

Condition MeSH for PROVENGE
Intervention	Trials
Prostatic Neoplasms	16
Carcinoma	1

Clinical Trial Locations for PROVENGE

Trials by Country

Trials by Country for PROVENGE
Location	Trials
United States	22

Trials by US State

Trials by US State for PROVENGE
Location	Trials
Texas	4
North Carolina	4
California	3
Connecticut	1
Florida	1

Clinical Trial Progress for PROVENGE

Clinical Trial Phase

Clinical Trial Phase for PROVENGE
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	10
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for PROVENGE
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Withdrawn	2

Clinical Trial Sponsors for PROVENGE

Sponsor Name

Sponsor Name for PROVENGE
Sponsor	Trials
Dendreon	6
The University of Texas Health Science Center, Houston	2
Duke University	2

Sponsor Type

Sponsor Type for PROVENGE
Sponsor	Trials
Other	18
Industry	10
NIH	1