Prostate CancerPhase 2NCT00090545

A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

A Phase 2 study testing BAY 43-9006 in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This study will investigate its effect on prostate cancer and its side effects. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: BAY 43-9006
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2004to 1 Apr 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI) or Pathology Department of the National Naval Medical Center prior to entering this study. Patients whose pathology specimens are no longer available may be enrolled in the trial if the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis. In cases where original tissue blocks or archival biopsy material is available, all efforts should be made to have the material forwarded to the research team for use in correlative studies.
Patients must have metastatic progressive androgen-independent prostate cancer. There must be radiographic evidence of disease after primary treatment with either surgery or radiotherapy that has continued to progress despite hormonal agents. Progression requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostatic specific antigen (PSA) is continuing to rise on successive measurements. Patients on flutamide must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide must have progression at least 6 weeks after withdrawal.
Patients may have had no more than 1 previous cytoxic chemotherapeutic line.
Because no dosing or adverse event data are currently available on the use of BAY 43-9006 (Sorafenib) in patients less than 18 years of age, children are excluded from this study.
Patients must have a life expectancy of more than 3 months.
Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria.

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Patient must have adequate organ function as defined below:
Leukocytes greater than or equal to 3,000/microL
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Total bilirubin less than or equal to 1.5 X institutional upper limits of normal
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase(SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase(SGPT) less than or equal to 2.5 X institutional upper limit of normal
Creatinine less than or equal to 1.5 X institutional upper limits of normal OR:
Creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be less than or equal to grade 1 or returned to baseline.
Hormonal profile: all patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of gonadotropin releasing hormone (GnRH) agonists.
Patients must not have other invasive malignancies (within the past two years with the exception of non-melanoma skin cancers or non-invasive bladder cancer).
Patients must be able to understand and sign an informed consent form.
Concurrent use of bisphosphonates will be allowed for patients with known bone metastases
Patients who require hematopoietic growth factor support (e.g. epogen, darbepoetin), non-steroidal anti-inflammatory drug (NSAIDs), and other maintenance medications prior to study entry will be allowed to continue their supportive therapies.
The effects of BAY 43-9006 (Sorafenib) on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Raf-kinase inhibitors are known to be teratogenic, men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Men of all races and ethnic groups are eligible for this trial. Women are excluded by the nature of the disease.

Who cannot join

Patients who have had chemotherapy or radiotherapy (including radioisotopes) within 4 weeks (6 weeks for nitrosoureas or mitomycin C, greater than 3 months for suramin) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not be receiving any other investigational agents.
Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 (Sorafenib)
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Hypertension as defined by systolic blood pressure in excess of 170 mmHg or diastolic pressure in excess of 100 mmHg. Patients with a history of hypertension that is well controlled on medication will not be excluded. Patients may not be on either verapamil or diltiazem while on study. Use of calcium channel blocker should be discouraged.

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Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006 (Sorafenib). Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
History of bleeding diathesis
Patients on therapeutic anticoagulation are at increased risk from bleeding while on BAY 43-9006 (Sorafenib). Prophylactic anticoagulation (i.e. low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for prothrombin time (PT), International normalized ratio (INR) or partial thromboplastin time (PTT) are met: PT less than 1.1 x institutional upper limit of normal; INR less than 1.1; PTT within the institutional limits of normal. These requirements will only be made upon those patients on warfarin.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Cancer Institute (NCI)
Bethesda, Maryland, 20892

Other trials in United States

About this study

Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning and evening. Blood will be taken throughout the day to determine the drug's level in the bloodstream.

Patients will be discharged from the hospital on the second day, and will continue to take the drug twice daily until instructed to stop. During each of the first 4 weeks, patients will be required to have their blood pressure checked. At the end of the first 4 weeks, patients will have a physical examination and blood tests, as well as a second tumor or bone marrow biopsy.

After the first 4 weeks, patients will continue with their drug regimen. At the end of each 4-week cycle, patients will have a physical examination and blood tests. Patients will also have x-Rays, computed tomography (CT) scans, and/or magnetic resonance imaging (MRIs) at every other 4-week examination or as required. Patients will be asked to keep a diary recording the time and amount of their medication for this study.

Read the detailed description

BAY 43-9006 (Sorafenib) is a potent inhibitor of wild-type and mutant b-Raf and c-Raf kinase isoforms in vitro. In addition, this agent also inhibits p38, c-kit, vascular endothelial growth factor receptor 2 (VEGFR-2) and platelet-derived growth factor receptor beta (PDGFR-beta) affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf. At this time, over 500 patients have been treated with this drug with tolerable side effects.

The primary objective of this study is to determine if BAY 43-9006 (Sorafenib) is associated with a 50% 4 month probability of progression free survival in patients with metastatic androgen independent prostate cancer (AIPC) as determined by clinical, radiographic, and prostatic specific antigen (PSA) criteria.

The secondary objective of this study will be demonstration of biologic effect by the drug in the patient and on the tumor (when possible). Correlative studies will be conducted on serially obtained tissue biopsies, bone marrow biopsies, and white blood cell collections. These laboratory correlates will include elucidation of activation of components of the Raf-extracellular-signal regulated kinase (ERK)-methyl ethyl ketone (MEK) and angiogenesis pathways using protein microarray technologies developed by the National Cancer Institute (NCI)/Food and Drug Administration (FDA) clinical proteomics program.

Per Amendment D, a secondary objective of this study will also be to determine the time to progression measured by clinical and radiographic criteria. The 22 patients treated on the first stage of this protocol will be retrospectively evaluated with respect to this secondary endpoint possible. Please refer to the statistics section for further details.

The combination of correlated clinical and laboratory endpoints with emphasis on molecular signaling will provide new information on the anti-tumor effects helping to characterize its role in the treatment of androgen independent prostate cancer (AIPC).

Conditions: Prostate Cancer
Being tested: BAY 43-9006
Keywords: Hormone-Refractory, Proteomics, Angiogenesis, VEGFR, Prostate Cancer, Metastatic Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY 43-9006Drug
Also called sorafenib
400 mg BAY 43-9006 orally twice daily in 28 day cycles.

Study groups in NCT00090545
Study group	Role	What they receive
First Stage - disease progression	Experimental	The first stage was to rule out the probability of 4 month progression free survival. Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles. Receives: Drug: BAY 43-9006
Second Stage - increased accrual	Experimental	Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage. Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles. Receives: Drug: BAY 43-9006

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival
Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.
Measured: 4 months

Secondary outcomes (6)

Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Measured: Date treatment consent signed to date off study, approximately 49 months.
Median Overall Survival
Time from treatment start date until date of death or date last known alive.
Measured: Time from treatment start date until date of death or date last known alive, approximately 18.3 months.
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Overall response was evaluated by the RECIST. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Every 2 cycles (1 cycle = 28 days)
Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)
Plasma concentration-time profile for sorafenib.
Measured: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose
Geometric Mean for Exposure Area Under the Curve (AUC) 0-12
Geometric mean exposure for sorafenib.
Measured: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)
Time to maximum concentration for sorafenib.
Measured: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20041 Apr 2009

First posted27 Aug 2004 (estimated)
Study start1 Sep 2004
Primary completion1 Sep 2007
Study completion1 Apr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090545
Sponsor's protocol ID: 040262
Other IDs: 04-C-0262
Status last verified: Jun 2018
First submitted: 27 Aug 2004
Last updated: 14 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Klotz L. Hormone therapy for patients with prostate carcinoma. Cancer. 2000 Jun 15;88(12 Suppl):3009-14. doi: 10.1002/1097-0142(20000615)88:12+3.3.co;2-5.
PubMed 10898345
Peer CJ, Sissung TM, Kim A, Jain L, Woo S, Gardner ER, Kirkland CT, Troutman SM, English BC, Richardson ED, Federspiel J, Venzon D, Dahut W, Kohn E, Kummar S, Yarchoan R, Giaccone G, Widemann B, Figg WD. Sorafenib is an inhibitor of UGT1A1 but is metabolized by UGT1A9: implications of genetic variants on pharmacokinetics and hyperbilirubinemia. Clin Cancer Res. 2012 Apr 1;18(7):2099-107. doi: 10.1158/1078-0432.CCR-11-2484. Epub 2012 Feb 3.
PubMed 22307138
Jain L, Woo S, Gardner ER, Dahut WL, Kohn EC, Kummar S, Mould DR, Giaccone G, Yarchoan R, Venitz J, Figg WD. Population pharmacokinetic analysis of sorafenib in patients with solid tumours. Br J Clin Pharmacol. 2011 Aug;72(2):294-305. doi: 10.1111/j.1365-2125.2011.03963.x.
PubMed 21392074
Jain L, Sissung TM, Danesi R, Kohn EC, Dahut WL, Kummar S, Venzon D, Liewehr D, English BC, Baum CE, Yarchoan R, Giaccone G, Venitz J, Price DK, Figg WD. Hypertension and hand-foot skin reactions related to VEGFR2 genotype and improved clinical outcome following bevacizumab and sorafenib. J Exp Clin Cancer Res. 2010 Jul 14;29(1):95. doi: 10.1186/1756-9966-29-95.
PubMed 20630084
Azad NS, Aragon-Ching JB, Dahut WL, Gutierrez M, Figg WD, Jain L, Steinberg SM, Turner ML, Kohn EC, Kong HH. Hand-foot skin reaction increases with cumulative sorafenib dose and with combination anti-vascular endothelial growth factor therapy. Clin Cancer Res. 2009 Feb 15;15(4):1411-6. doi: 10.1158/1078-0432.CCR-08-1141.
PubMed 19228742
Jain L, Gardner ER, Venitz J, Dahut W, Figg WD. Development of a rapid and sensitive LC-MS/MS assay for the determination of sorafenib in human plasma. J Pharm Biomed Anal. 2008 Jan 22;46(2):362-7. doi: 10.1016/j.jpba.2007.10.027.
PubMed 18309574
Kong HH, Cowen EW, Azad NS, Dahut W, Gutierrez M, Turner ML. Keratoacanthomas associated with sorafenib therapy. J Am Acad Dermatol. 2007 Jan;56(1):171-2. doi: 10.1016/j.jaad.2006.10.032. No abstract available.
PubMed 17190642
Aragon-Ching JB, Jain L, Gulley JL, Arlen PM, Wright JJ, Steinberg SM, Draper D, Venitz J, Jones E, Chen CC, Figg WD, Dahut WL. Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. BJU Int. 2009 Jun;103(12):1636-40. doi: 10.1111/j.1464-410X.2008.08327.x. Epub 2009 Jan 9.
PubMed 19154507
Dahut WL, Scripture C, Posadas E, Jain L, Gulley JL, Arlen PM, Wright JJ, Yu Y, Cao L, Steinberg SM, Aragon-Ching JB, Venitz J, Jones E, Chen CC, Figg WD. A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res. 2008 Jan 1;14(1):209-14. doi: 10.1158/1078-0432.CCR-07-1355.
PubMed 18172272

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
ClinicalTrials.gov ID: NCT00090545
Acronym / sponsor ID: 040262
Conditions: Prostate Cancer
Keywords: Hormone-Refractory, Proteomics, Angiogenesis, VEGFR, Prostate Cancer, Metastatic Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 1 Sep 2004 (actual)
Primary completion: 1 Sep 2007 (actual)
Study completion: 1 Apr 2009 (actual)
First posted: 27 Aug 2004 (estimated)
Results: Posted 28 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
First Stage - disease progression	Experimental	Drug: BAY 43-9006The first stage was to rule out the probability of 4 month progression free survival. Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.
Second Stage - increased accrual	Experimental	Drug: BAY 43-9006Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage. Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Patients must have histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI) or Pathology Department of the National Naval Medical Center prior to entering this study. Patients whose pathology specimens are no longer available may be enrolled in the trial if the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis. In cases where original tissue blocks or archival biopsy material is available, all efforts should be made to have the material forwarded to the research team for use in correlative studies.
Patients must have metastatic progressive androgen-independent prostate cancer. There must be radiographic evidence of disease after primary treatment with either surgery or radiotherapy that has continued to progress despite hormonal agents. Progression requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostatic specific antigen (PSA) is continuing to rise on successive measurements. Patients on flutamide must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide must have progression at least 6 weeks after withdrawal.
Patients may have had no more than 1 previous cytoxic chemotherapeutic line.
Because no dosing or adverse event data are currently available on the use of BAY 43-9006 (Sorafenib) in patients less than 18 years of age, children are excluded from this study.
Patients must have a life expectancy of more than 3 months.

Key exclusion criteria (9 listed)

Patients who have had chemotherapy or radiotherapy (including radioisotopes) within 4 weeks (6 weeks for nitrosoureas or mitomycin C, greater than 3 months for suramin) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not be receiving any other investigational agents.
Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 (Sorafenib)
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BAY 43-9006Also: sorafenib400 mg BAY 43-9006 orally twice daily in 28 day cycles.	Drug	First Stage - disease progression, Second Stage - increased accrual

Primary outcome

Progression Free Survival
Time frame: 4 months
Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.

6 secondary outcomes

Number of Participants With Adverse Events
Time frame: Date treatment consent signed to date off study, approximately 49 months.
Median Overall Survival
Time frame: Time from treatment start date until date of death or date last known alive, approximately 18.3 months.
Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Every 2 cycles (1 cycle = 28 days)
Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)
Time frame: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose
Geometric Mean for Exposure Area Under the Curve (AUC) 0-12
Time frame: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)
Time frame: 0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose

Results and safety

Results posted to the registry on 28 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Stage - Disease Progression	22	0
Second Stage - Increased Accrual	24	0

Primary outcome: Progression Free Survival

Time frame: 4 months. Median (95% Confidence Interval). Unit: months

Measure	First Stage - Disease Progression n = 22	Second Stage - Increased Accrual n = 24
Value	1.83 (1.77 to 3.65)	3.7 (1.8 to 4.9)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Date treatment consent signed to date off study, approximately 49 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
First Stage - Disease Progression	2 of 22 (9.1%)	22 of 22 (100%)	0 of 22
Second Stage - Increased Accrual	6 of 24 (25%)	23 of 24 (95.8%)	1 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10898345Klotz L. Hormone therapy for patients with prostate carcinoma. Cancer. 2000 Jun 15;88(12 Suppl):3009-14. doi: 10.1002/1097-0142(20000615)88:12+3.3.co;2-5.
Background: PubMed 22307138Peer CJ, Sissung TM, Kim A, Jain L, Woo S, Gardner ER, Kirkland CT, Troutman SM, English BC, Richardson ED, Federspiel J, Venzon D, Dahut W, Kohn E, Kummar S, Yarchoan R, Giaccone G, Widemann B, Figg WD. Sorafenib is an inhibitor of UGT1A1 but is metabolized by UGT1A9: implications of genetic variants on pharmacokinetics and hyperbilirubinemia. Clin Cancer Res. 2012 Apr 1;18(7):2099-107. doi: 10.1158/1078-0432.CCR-11-2484. Epub 2012 Feb 3.
Background: PubMed 21392074Jain L, Woo S, Gardner ER, Dahut WL, Kohn EC, Kummar S, Mould DR, Giaccone G, Yarchoan R, Venitz J, Figg WD. Population pharmacokinetic analysis of sorafenib in patients with solid tumours. Br J Clin Pharmacol. 2011 Aug;72(2):294-305. doi: 10.1111/j.1365-2125.2011.03963.x.
Background: PubMed 20630084Jain L, Sissung TM, Danesi R, Kohn EC, Dahut WL, Kummar S, Venzon D, Liewehr D, English BC, Baum CE, Yarchoan R, Giaccone G, Venitz J, Price DK, Figg WD. Hypertension and hand-foot skin reactions related to VEGFR2 genotype and improved clinical outcome following bevacizumab and sorafenib. J Exp Clin Cancer Res. 2010 Jul 14;29(1):95. doi: 10.1186/1756-9966-29-95.
Background: PubMed 19228742Azad NS, Aragon-Ching JB, Dahut WL, Gutierrez M, Figg WD, Jain L, Steinberg SM, Turner ML, Kohn EC, Kong HH. Hand-foot skin reaction increases with cumulative sorafenib dose and with combination anti-vascular endothelial growth factor therapy. Clin Cancer Res. 2009 Feb 15;15(4):1411-6. doi: 10.1158/1078-0432.CCR-08-1141.
Background: PubMed 18309574Jain L, Gardner ER, Venitz J, Dahut W, Figg WD. Development of a rapid and sensitive LC-MS/MS assay for the determination of sorafenib in human plasma. J Pharm Biomed Anal. 2008 Jan 22;46(2):362-7. doi: 10.1016/j.jpba.2007.10.027.
Background: PubMed 17190642Kong HH, Cowen EW, Azad NS, Dahut W, Gutierrez M, Turner ML. Keratoacanthomas associated with sorafenib therapy. J Am Acad Dermatol. 2007 Jan;56(1):171-2. doi: 10.1016/j.jaad.2006.10.032. No abstract available.
Results publication: PubMed 19154507Aragon-Ching JB, Jain L, Gulley JL, Arlen PM, Wright JJ, Steinberg SM, Draper D, Venitz J, Jones E, Chen CC, Figg WD, Dahut WL. Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. BJU Int. 2009 Jun;103(12):1636-40. doi: 10.1111/j.1464-410X.2008.08327.x. Epub 2009 Jan 9.
Results publication: PubMed 18172272Dahut WL, Scripture C, Posadas E, Jain L, Gulley JL, Arlen PM, Wright JJ, Yu Y, Cao L, Steinberg SM, Aragon-Ching JB, Venitz J, Jones E, Chen CC, Figg WD. A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res. 2008 Jan 1;14(1):209-14. doi: 10.1158/1078-0432.CCR-07-1355.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Dahut, M.D. principal investigator

National Cancer Institute, National Institutes of Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY 43-9006 in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00090545, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.