Abiraterone Post Ketoconazole for Prostate Cancer

NCT01199146 | Completed Phase 2 Results DMC

• 1 other identifier: CC# 085514
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole. It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole

Conditions

Prostate Cancer

Keywords

Abiraterone acetate

Outcome Measures

Primary Outcomes (1)

• Preliminary Evidence of Efficacy of Abiraterone Acetate

  number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment

  12 weeks from beginning of abiraterone treatment

Secondary Outcomes (2)

• Time To Progression (TTP)

  beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria

• Proportion of Patients With PSA Decline of > 50%

  12 weeks from beginning of therapy

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

Drug: Abiraterone acetate

Interventions

Abiraterone acetate DRUG

Abiraterone acetate 1000 mg by mouth per day

Also known as: CB7630

Abiraterone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Prior therapy with ketoconazole for castration resistant prostate cancer. Patients should demonstrate evidence of progression (see below definitions) on ketoconazole or evidence of grades 3/4 toxicities on ketoconazole.
• Ketoconazole must have been administered for \>28 days
• At least 27 days must elapse since last ketoconazole dose and first dose of abiraterone acetate
• No prior therapy with chemotherapy for metastatic prostate cancer
• Metastatic disease based on a positive bone scan or objective imaging on CT scan
• Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
• Testosterone \< 50 ng/dL
• Progressive disease after androgen deprivation: PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart
• Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen
• ECOG Performance Status 0-1
• Age \>18 years and able to comply with protocol requirements
• Serum Creatinine ≤1.5 x ULN
• Serum potassium \>3.5mmol/L
• Bilirubin ≤1.5x ULN

You may not qualify if:

• Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid 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 and Soy supplements
• Prior radiation therapy completed \< 4 weeks prior to enrollment
• Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that \>1 year has passed since the administration of the last chemotherapy dose.
• Hemoglobin ≤9.0 g/dL
• Any "currently active" second malignancy, other than non-melanoma skin cancer Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
• Blood pressure that is not controlled despite \>2 oral agents (SBP \>160 and DBP \>90 on three or more readings within the screening period)
• Serum K+ \<3.5 mmoL/L on more than one reading within the screening period
• NYHA Class II, 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
• Concurrent therapy with drugs that are metabolized as substrates of CYP1A2, CYP2D6, or CYP2C19 and are considered by the investigators to pose a risk for drug to drug interactions

Sponsors & Collaborators

• University of California, San Francisco: lead
• Johnson & Johnson: collaborator
• Cougar Biotechnology, Inc.: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Charles Ryan, MD
• Organization: University of California, San Francisco

charles.ryan@ucsf.edu

415-353-9279

Study Officials

• Charles J Ryan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 10, 2010
• Primary Completion: January 4, 2013
• Study Completion: March 14, 2016
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2017-12

Locations

US (2)