Prostate CancerPhase 1/2NCT00414388
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
A Phase 1/2 study testing Sorafenib in people with Prostate Cancer, run by Oncology Specialists, S.C. at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Mar 2012
- Phase
- Phase 1/2
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- Patients with a known diagnosis of prostate cancer regardless of their Gleason grade.
- Patients have AIPC.
- Adequate bone marrow, liver and renal function as assessed by:
- Hemoglobin > 9.0 g/dl
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- absolute neutrophil count (ANC) > 1,000/mm3
- Platelet count > 75,000/mm3
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x the ULN (< 5 x ULN for patients with liver involvement). international normalized ratio (INR) < 1.5 or a Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
- Creatinine < 1.5 x ULN
- Transfusions and the use of growth factors (for red and white cells) are allowed
- Patients must have received either docetaxel or mitoxantrone as the chemotherapy regimen
- Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- Patients must have progressed while receiving systemic chemotherapy for AIPC. Patients could have progressed within 12 weeks of their last systemic chemotherapy administration. The definition of progression is defined as follows:
- 1-For patients who are receiving systemic chemotherapy (one criteria is sufficient):
- Increase in prostate-specific antigen (PSA) by 25% or more than the previous value. This should be repeated within 3 weeks (while patient is off chemotherapy) to confirm that the PSA did not decrease.
- For patients with visceral disease, radiographic evidence of progression by standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria (regardless of the PSA value).
- For patients with bone only disease, progression on a whole body bone scan (2 or more new lesions) is sufficient to fulfill the definition of progressive disease, regardless of PSA value or the visceral disease status.
- 2-For patients who have received chemotherapy previously (Both criteria are needed):
- Not more than 12 weeks have elapsed since last chemotherapy administration
- Either biochemical progression (25% increase in PSA that is confirmed with a repeat analysis within 3 weeks), OR radiographic progression (RECIST criteria for visceral disease patients OR 2 or more lesions on a whole body bone scan)
Who cannot join
- Cardiac disease: Congestive heart failure > class II New York Heart Association 9NYHA). Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
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- Active clinically serious infection > Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or uncontrolled coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Onocology Specialists, S.C
Niles, Illinois, 60714
Oncology Specialists, S.C
Park Ridge, Illinois, 60068
About this study
Official title: Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
Read the detailed description
Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.
- Conditions
- Prostate Cancer
- Being tested
- Sorafenib
- Keywords
- AIPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
400mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Single agent Sorafenib | Experimental | Oral Single agent Sorafenib 400mg twice daily Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Needing a Dose Reduction.
The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%
Measured: participants were followed for an average of 25 months
Secondary outcomes (2)
Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.
Measured: 3-10 months
PSA -Biochemical Response
PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.
Measured: 1-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2011
- Study completionMar 2012
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.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Specialists, S.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
- Investigators
- Chadi Nabhan, MD, Principal investigator, Oncology Specialists, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414388
- Sponsor's protocol ID
- 0603
- Status last verified
- Feb 2014
- First submitted
- 19 Dec 2006
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)
- ClinicalTrials.gov ID
- NCT00414388
- Acronym / sponsor ID
- 0603
- Conditions
- Prostate Cancer
- Keywords
- AIPC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oncology Specialists, S.C.University, hospital or other
- Study start
- Dec 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
Detailed description
Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single agent Sorafenib | Experimental | Drug: SorafenibOral Single agent Sorafenib 400mg twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age > 18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- Patients with a known diagnosis of prostate cancer regardless of their Gleason grade.
- Patients have AIPC.
- Adequate bone marrow, liver and renal function as assessed by:
Key exclusion criteria (16 listed)
- Cardiac disease: Congestive heart failure > class II New York Heart Association 9NYHA). Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
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 |
|---|---|---|
| SorafenibAlso: Nexavar400mg twice daily | Drug | Single agent Sorafenib |
Primary outcome
Percentage of Patients Needing a Dose Reduction.
Time frame: participants were followed for an average of 25 months
The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%
2 secondary outcomes
Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Time frame: 3-10 months
PSA -Biochemical Response
Time frame: 1-10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chadi Nabhan, MD principal investigator
Oncology Specialists, SC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib in people with Prostate Cancer, run by Oncology Specialists, S.C. at 2 sites 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 16 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Apr 2014). 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?
Percentage of Patients Needing a Dose Reduction. (time frame: participants were followed for an average of 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.