Prostate CancerPhase 2NCT01845792
Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer
A Phase 2 study testing Cabazitaxel with Abiraterone Acetate and Cabazitaxel in people with Prostate Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cabazitaxel with Abiraterone Acetate and Cabazitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2017
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained.
- Adults over 18 years of age.
- Histologically or cytologically proven adenocarcinoma of the prostate.
- Stage IV disease as evidenced by soft tissue, visceral and/or bony metastasis must be Response Evaluation Criteria in Solid Tumors (RECIST) evaluable on CT scan and/or bone scan
- Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:
- Increase in measurable disease per RECIST 1.1,
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- Appearance of new lesions on bone scan consistent with progressive prostate cancer (>2 new lesions on bone scans if this is the only measure of PD),
- rising PSA defined as 2 sequential increases above a previous lowest reference value.
- Each value must be obtained at least 1 week apart.
- PSA at least 2 ng/mL
- Received prior docetaxel chemotherapy
- Received prior abiraterone acetate, but not within the 3 months prior to study drug dosing.
- Testosterone level <50 ng/mL. Patients receiving Leutinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must be continued to maintain castrate levels of testosterone while on study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate hematologic function:
- platelet >100, 000/uL;
- neutrophil count of >1500 cell/mm3;
- hemoglobin >9.0 g/dL)
- Adequate renal function (Creatinine clearance > 50 mL/min)
- Adequate potassium level (> 3.5 mEq/dL)
- Adequate hepatic function
- bilirubin < 1.5 X upper limit of normal (ULN),
- alanine aminotransferase (ALT) < 1.5 X ULN,
- aspartate aminotransferase (AST) < 1.5 X ULN.
- serum albumin of ≥ 3.0 g/dL.
- Controlled blood pressure, defined as blood pressure ≤ 140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
- Must be able to take oral medication without crushing, dissolving or chewing tablets
- Willing to take abiraterone acetate on empty stomach;
- no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken.
- Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Written authorization for use and release of health and research study information has been obtained.
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of abiraterone acetate.
Who cannot join
- Surgery or radiation therapy within 2 weeks, or
- Cytotoxic anti-cancer therapy within 3 weeks, or
- Non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever is shorter) of Study Day 1.
- Prior radiotherapy to ≥ 40% of bone marrow.
- Prior treatment with Radium 223.
- Use of an investigational therapeutic agent within 30 days.
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- Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents.
- Prior treatment with cabazitaxel.
- Known chronic infection with human immunodeficiency virus (HIV).
- Known active, or symptomatic, brain metastasis.
- Blood pressure >140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged).
- History of autoimmune disorder requiring daily corticosteroid therapy of greater than prednisone 10mg daily, or its equivalent.
- Baseline peripheral edema > grade 3.
- Pre-existing diarrhea uncontrolled with supportive care;
- Prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause;
- Active, uncontrolled peptic ulcer disease even in the setting of proton-pump inhibitor or Histamine2-blocker use.
- Pre-existing peripheral neuropathy grade > 2.
- Documented hypersensitivity (CTCAE grade > 2) to any drug containing polysorbate 80.
- Have known allergies or hypersensitivity to abiraterone acetate or prednisone or their excipients.
- Contraindications to steroid use.
- Need for medications that strongly induce or inhibit cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2D6 (CYP2D6) activity. (see section 7.2.3 for details)
- Serious infection requiring parenteral antibiotics within 14 days of enrollment.
- Poorly controlled diabetes (Hgb A1C >9).
- Active or symptomatic viral hepatitis or Chronic liver disease, including Child-Pugh Class B and C liver disease.
- History of pituitary or adrenal dysfunction.
- Clinically significant heart disease as evidenced by:
- myocardial infarction, or
- arterial thrombotic events in the past 6 months,
- severe or unstable angina, or
- New York Heart Association Class III-IV heart disease, or
- cardiac ejection fraction measurement of <50% at baseline.
- Consumption of food or beverages containing grapefruit juice within 7 days of study drug dosing
- Use of a first-generation anti-androgen such as:
- bicalutamide within 6 weeks of study drug dosing, or
- flutamide within 4 weeks of study dosing.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.
Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
Read the detailed description
Abiraterone acetate and cabazitaxel have been approved by the United States Food and Drug Administration (FDA) to treat prostate cancer that has spread to other parts of the body such as the lymph nodes or bone. These drugs are approved individually for use when the cancer has become resistant to other treatments, including chemotherapy with docetaxel. The combination of these two drugs has not been evaluated, so the research team will study the safety and effectiveness of the combination.
- Conditions
- Prostate Cancer
- Being tested
- Cabazitaxel with Abiraterone Acetate, Cabazitaxel
- Keywords
- Metastatic Castrate Resistant 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.
Cabazitaxel with Abiraterone AcetateDrug
Also called Jevtana, Zytiga
Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
CabazitaxelDrug
Also called Jevtana
Cabazitaxel intravenously every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel with Abiraterone Acetate | Experimental | Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Receives: Drug: Cabazitaxel with Abiraterone Acetate |
| Cabazitaxel Alone | Active comparator | Cabazitaxel administered as a single intravenous dose every 3 weeks Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-free survival at 3 months.
Measured: 3 months
Secondary outcomes (1)
PSA Response
Prostate specific antigen (PSA) decline by 50% or more from baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Low accrual
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.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Services, LLC
- Responsible party
- Sponsor
- Investigators
- Elaine Lam, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845792
- Sponsor's protocol ID
- 13-1489.cc
- Other IDs
- NCI-2013-01356
- Status last verified
- May 2018
- First submitted
- 29 Apr 2013
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01845792
- Acronym / sponsor ID
- 13-1489.cc
- Conditions
- Prostate Cancer
- Keywords
- Metastatic Castrate Resistant Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Janssen Services, LLC
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
Detailed description
Abiraterone acetate and cabazitaxel have been approved by the United States Food and Drug Administration (FDA) to treat prostate cancer that has spread to other parts of the body such as the lymph nodes or bone. These drugs are approved individually for use when the cancer has become resistant to other treatments, including chemotherapy with docetaxel. The combination of these two drugs has not been evaluated, so the research team will study the safety and effectiveness of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel with Abiraterone Acetate | Experimental | Drug: Cabazitaxel with Abiraterone AcetateCabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. |
| Cabazitaxel Alone | Active comparator | Drug: CabazitaxelCabazitaxel administered as a single intravenous dose every 3 weeks |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Written informed consent has been obtained.
- Adults over 18 years of age.
- Histologically or cytologically proven adenocarcinoma of the prostate.
- Stage IV disease as evidenced by soft tissue, visceral and/or bony metastasis must be Response Evaluation Criteria in Solid Tumors (RECIST) evaluable on CT scan and/or bone scan
- Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:
Key exclusion criteria (36 listed)
- Surgery or radiation therapy within 2 weeks, or
- Cytotoxic anti-cancer therapy within 3 weeks, or
- Non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever is shorter) of Study Day 1.
- Prior radiotherapy to ≥ 40% of bone marrow.
- Prior treatment with Radium 223.
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 |
|---|---|---|
| Cabazitaxel with Abiraterone AcetateAlso: Jevtana, ZytigaCabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily. | Drug | Cabazitaxel with Abiraterone Acetate |
| CabazitaxelAlso: JevtanaCabazitaxel intravenously every 3 weeks | Drug | Cabazitaxel Alone |
Primary outcome
Progression-Free Survival
Time frame: 3 months
Progression-free survival at 3 months.
1 secondary outcome
PSA Response
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elaine Lam, MD principal investigator
University of Colorado, Denver
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 Cabazitaxel with Abiraterone Acetate and Cabazitaxel in people with Prostate Cancer, run by University of Colorado, Denver 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 32 inclusion and 36 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: stopped early, as of the sponsor's last update on 4 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 4 Jun 2018). 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: 3 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 4 Jun 2018.