Prostate NeoplasmsPhase 1mCRPCNCT01400555
A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1 study testing Cohort 4, Cohort 3 and Cohort 2 in people with Prostate Neoplasms and Prostate Cancer, run by Cougar Biotechnology, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasms, Prostate Cancer
- What is being tested?
- Cohort 4, Cohort 3 and Cohort 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2011to 28 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adenocarcinoma of the prostate
- Metastatic disease documented by bone, computed tomography (CT), or magnetic resonance image (MRI) scan
- Surgical or medical castration with testosterone less than 50 ng/dL
- Prostate cancer progression documented by 1 of the following: PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria, radiographic progression by modified Response Evaluation Criteria in Solid Tumors (RECIST) or bone scan
- Absolute neutrophil count >1,500 cells/mm3
- Platelets >100,000/µl
- Hemoglobin >=10.0 g/dL
- Eastern Cooperative Group (ECOG) status score of <=2.
Who cannot join
- Elevated liver function tests (LFTs): Serum bilirubin >upper limit of normal (ULN), alanine (ALT) or aspartate (AST) aminotransferase > 1.5 ULN concomitant with alkaline phosphatase > 2.5 ULN
- Small cell carcinoma of the prostate
- Pulmonary or brain metastasis, liver metastasis is allowed if LFTs are not elevated
- Pre-existing neuropathy or severe fluid retention
- Prior cytotoxic chemotherapy for metastatic prostate cancer
- Prior therapy with other CYP17 inhibitor(s) or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer
Show all 10Show fewer
- Treatment of primary tumor within 4 weeks of Day 1 Week 1 with surgery, radiation, chemotherapy or immunotherapy
- Use of investigational drug within 4 weeks of Day 1 Week 1 or current enrollment in an investigational drug or device study
- Prior ketoconazole for prostate cancer
- Recent history of ischemic heart disease, electrocardiogram (ECG) abnormalities, or atrial fibrillation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
New York, New York
About this study
Official title: A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).
Read the detailed description
This is an open-label (patients and their doctors will know the identity of study drug administered), uncontrolled (patients are not assigned to treatment by chance), multicenter safety study of escalating dose levels of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). This study is conducted in 2 parts. Part I consists of Screening, Treatment, assessment of dose-limiting toxicity (DLT), and determination of the maximum tolerated dose (MTD). Participants are enrolled in sequential 6-subject cohorts (groups) and administered combination therapy (abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule. The abiraterone acetate dose in this study will escalate from 500 mg to 1000 mg daily until the MTD is determined. The MTD is the highest combination dose among the dose combinations investigated in this study at which no more than 2 (33%) of the patients in a cohort experience a DLT. A DLT is defined by an adverse event occurring from Day 1 Week 2 (first dose of abiraterone acetate) to the day before the Day 1 Week 7 docetaxel infusion (3 weeks after the second docetaxel infusion); non-hematological toxicity >=Grade 3; Grade 4 neutropenia lasting more than 5 days, neutropenia complicated by fever, or systemic infection; thrombocytopenia <25,000/mcL, or any thrombocytopenia requiring platelet transfusion; and, any subjectively intolerable toxicity. Part II of the study consists of Continuing Treatment, when patients remain at the allocated dose level, escalate to the combination MTD, or discontinuation of docetaxel (if toxicity or intolerability develops) and continue abiraterone acetate (up to 1000 mg/day) plus prednisone, until disease progression; End of Treatment, when posttreatment efficacy and safety will be documented; and Follow-Up, when survival status and new antitumor therapy are monitored. Blood samples for pharmacokinetic and efficacy measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation may be up to 36 months. Oral abiraterone acetate will be administered as a single daily dose (500, 750, or 1000 mg). Docetaxel will be administered once every 3 weeks as an intravenous (IV) infusion (60 or 75 mg/m2) over 1 hour. Study participants will premedicate with oral dexamethasone 8 mg 1, 3, and 12 hours before the start of each docetaxel IV infusion. Oral prednisone 5 mg will be administered twice daily.
- Conditions
- Prostate Neoplasms, Prostate Cancer
- Being tested
- Cohort 4, Cohort 3, Cohort 2, Cohort 1
- Keywords
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Abiraterone Acetate, Docetaxel, Prednisone, Dexamethasone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 4Drug
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
Cohort 3Drug
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
Cohort 2Drug
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
Cohort 1Drug
Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Cohort 1 Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day Receives: Drug: Cohort 1 |
| 002 | Experimental | Cohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day Receives: Drug: Cohort 2 |
| 003 | Experimental | Cohort 3 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day Receives: Drug: Cohort 3 |
| 004 | Experimental | Cohort 4 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day Receives: Drug: Cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a dose-limiting toxicity
Measured: Up through Week 6
Secondary outcomes (5)
Proportion of patients with prostate-specific antigen (PSA) response
Measured: Up to Month 36
Time to PSA progression
Measured: Up to Month 36
Objective response rate
Measured: Up to Month 36
Radiographic progression-free survival
Measured: Up to Month 36
Survival
Measured: Up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study start1 Sep 2011
- Primary completion12 May 2014
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cougar Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cougar Biotechnology, Inc. Clinical Trial, Study director, Cougar Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400555
- Sponsor's protocol ID
- CR018712
- Other IDs
- COU-AA-206
- Acronym
- mCRPC
- Status last verified
- Mar 2018
- First submitted
- 21 Jul 2011
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
PubMed 22747660
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT01400555
- Acronym / sponsor ID
- mCRPC / CR018712
- Conditions
- Prostate Neoplasms, Prostate Cancer
- Keywords
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Abiraterone Acetate, Docetaxel, Prednisone, Dexamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 12 May 2014 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
This is an open-label (patients and their doctors will know the identity of study drug administered), uncontrolled (patients are not assigned to treatment by chance), multicenter safety study of escalating dose levels of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). This study is conducted in 2 parts. Part I consists of Screening, Treatment, assessment of dose-limiting toxicity (DLT), and determination of the maximum tolerated dose (MTD). Participants are enrolled in sequential 6-subject cohorts (groups) and administered combination therapy (abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule. The abiraterone acetate dose in this study will escalate from 500 mg to 1000 mg daily until the MTD is determined. The MTD is the highest combination dose among the dose combinations investigated in this study at which no more than 2 (33%) of the patients in a cohort experience a DLT. A DLT is defined by an adverse event occurring from Day 1 Week 2 (first dose of abiraterone acetate) to the day before the Day 1 Week 7 docetaxel infusion (3 weeks after the second docetaxel infusion); non-hematological toxicity >=Grade 3; Grade 4 neutropenia lasting more than 5 days, neutropenia complicated by fever, or systemic infection; thrombocytopenia <25,000/mcL, or any thrombocytopenia requiring platelet transfusion; and, any subjectively intolerable toxicity. Part II of the study consists of Continuing Treatment, when patients remain at the allocated dose level, escalate to the combination MTD, or discontinuation of docetaxel (if toxicity or intolerability develops) and continue abiraterone acetate (up to 1000 mg/day) plus prednisone, until disease progression; End of Treatment, when posttreatment efficacy and safety will be documented; and Follow-Up, when survival status and new antitumor therapy are monitored. Blood samples for pharmacokinetic and efficacy measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation may be up to 36 months. Oral abiraterone acetate will be administered as a single daily dose (500, 750, or 1000 mg). Docetaxel will be administered once every 3 weeks as an intravenous (IV) infusion (60 or 75 mg/m2) over 1 hour. Study participants will premedicate with oral dexamethasone 8 mg 1, 3, and 12 hours before the start of each docetaxel IV infusion. Oral prednisone 5 mg will be administered twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Cohort 1Cohort 1 Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day |
| 002 | Experimental | Drug: Cohort 2Cohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day |
| 003 | Experimental | Drug: Cohort 3Cohort 3 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day |
| 004 | Experimental | Drug: Cohort 4Cohort 4 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adenocarcinoma of the prostate
- Metastatic disease documented by bone, computed tomography (CT), or magnetic resonance image (MRI) scan
- Surgical or medical castration with testosterone less than 50 ng/dL
- Prostate cancer progression documented by 1 of the following: PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria, radiographic progression by modified Response Evaluation Criteria in Solid Tumors (RECIST) or bone scan
- Absolute neutrophil count >1,500 cells/mm3
Key exclusion criteria (10 listed)
- Elevated liver function tests (LFTs): Serum bilirubin >upper limit of normal (ULN), alanine (ALT) or aspartate (AST) aminotransferase > 1.5 ULN concomitant with alkaline phosphatase > 2.5 ULN
- Small cell carcinoma of the prostate
- Pulmonary or brain metastasis, liver metastasis is allowed if LFTs are not elevated
- Pre-existing neuropathy or severe fluid retention
- Prior cytotoxic chemotherapy for metastatic prostate cancer
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 |
|---|---|---|
| Cohort 4Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day | Drug | 004 |
| Cohort 3Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day | Drug | 003 |
| Cohort 2Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day | Drug | 002 |
| Cohort 1Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day | Drug | 001 |
Primary outcome
Proportion of patients with a dose-limiting toxicity
Time frame: Up through Week 6
5 secondary outcomes
Proportion of patients with prostate-specific antigen (PSA) response
Time frame: Up to Month 36
Time to PSA progression
Time frame: Up to Month 36
Objective response rate
Time frame: Up to Month 36
Radiographic progression-free survival
Time frame: Up to Month 36
Survival
Time frame: Up to Month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Derived from this study: PubMed 22747660Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
- Related InfoLink provided by the sponsor.
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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.
Cougar Biotechnology, Inc. Clinical Trial study director
Cougar Biotechnology, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 4, Cohort 3 and Cohort 2 in people with Prostate Neoplasms and Prostate Cancer, run by Cougar Biotechnology, Inc. at 3 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 8 inclusion and 10 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with a dose-limiting toxicity (time frame: Up through Week 6). 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 NCT01400555, which also lists 1 linked publication.
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 21 Mar 2018.