Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer
Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer
2 other identifiers
interventional
66
1 country
3
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2006
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 11, 2007
CompletedFirst Posted
Study publicly available on registry
May 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
April 29, 2014
CompletedApril 29, 2014
March 1, 2014
6.5 years
May 11, 2007
December 20, 2013
March 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.
Up to Cycle 12
Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.
Up to 12 weeks from start of treatment
Secondary Outcomes (15)
Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.
Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
- +10 more secondary outcomes
Study Arms (2)
Phase I Dose Escalation
EXPERIMENTALPhase II Dose Treatment
EXPERIMENTALInterventions
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established.
prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate
Eligibility Criteria
You may qualify if:
- Phase 1
- Histologically confirmed adenocarcinoma of the prostate
- No prior therapy with chemotherapy for prostate cancer
- Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy
- Testosterone \<50 ng/dL
- Progressive disease after androgen deprivation
- The presence of objective metastatic disease is NOT required for study eligibility
- Demonstrate disease progression after antiandrogen withdrawal
- Eastern Cooperative Oncology Group (ECOG) performance status score = 0-1
- Laboratory values within protocol-defined parameters
- Systolic blood pressure \<160 mmHg and diastolic blood pressure \<110mmHg documented on at least 3 different days
- Baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol \>18 µg/dL
- Agrees to protocol-defined use of effective contraception
- Life expectancy of \>=12 weeks
- Phase 2
- +4 more criteria
You may not qualify if:
- Phase 1
- Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease prostate specific antigen (PSA) levels (eg, saw palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
- Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug
- Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements
- Prior radiation therapy completed \<4 weeks prior to enrollment
- Prior chemotherapy for hormone refractory prostate cancer
- Any currently active second malignancy, other than non-melanoma skin cancer
- Systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=110 mmHg measured on at least 2 occasions
- NYHA Class III or IV congestive heart failure
- Myocardial infarction within the 6 months prior to the first dose of study drug
- Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled
- Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
- Phase 2
- Same as phase 1 with the following addition
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Houston, Texas, United States
Related Publications (1)
Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.
PMID: 24787968DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Research
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2007
First Posted
May 15, 2007
Study Start
June 1, 2006
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 29, 2014
Results First Posted
April 29, 2014
Record last verified: 2014-03