Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer

NCT01845792 | Terminated Phase 2 Results DMC

• 2 other identifiers: 13-1489.ccNCI-2013-01356
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Metastatic Castrate Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Progression-free survival at 3 months.

  3 months

Secondary Outcomes (1)

• PSA Response

  2 years

Study Arms (2)

Cabazitaxel with Abiraterone Acetate

EXPERIMENTAL

Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.

Drug: Cabazitaxel with Abiraterone Acetate

Cabazitaxel Alone

ACTIVE COMPARATOR

Cabazitaxel administered as a single intravenous dose every 3 weeks

Drug: Cabazitaxel

Interventions

Cabazitaxel with Abiraterone Acetate DRUG

Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.

Also known as: Jevtana, Zytiga

Cabazitaxel with Abiraterone Acetate

Cabazitaxel DRUG

Cabazitaxel intravenously every 3 weeks

Also known as: Jevtana

Cabazitaxel Alone

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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:

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Janssen Services, LLC: collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; 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: Elaine Lam, MD
• Organization: University of Colorado Cancer Center

elaine.lam@ucdenver.edu

7208480273

Study Officials

• Elaine Lam, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 4, 2018
• Results First Posted: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)