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Phase I/II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Metastatic Castrate Resistant Prostate Cancer That is Refractory to Docetaxel

Phase 1/Phase 2
18 Years
95 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I/II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Metastatic Castrate Resistant Prostate Cancer That is Refractory to Docetaxel

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 approved, so the research team will study the
safety and effectiveness of the combination.

Patients are being asked to participate in this study because their tumor has grown or
spread during therapy. Patients may benefit from a new combination of drugs to treat it.
Abiraterone acetate and prednisone have been shown to prevent the growth of prostate cancer
cells by lowering the level of testosterone in the blood. It works in different areas of
the body to block the production of this hormone that signals the cancer cells to grow.
Cabazitaxel and prednisone prevent cancer cells from growing by blocking certain structures
from functioning properly in the cell. These structures help cells divide and therefore
grow. By blocking their function, the cell will not be able to divide and will die.

Inclusion Criteria:

- 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: (1) Increase in measurable disease per
RECIST 1.1. (2) 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) (3)
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, but not within the 3 months prior to study drug dosing.
Prior therapy with abiraterone is not required for enrollment in the phase I study.

- Testosterone level <50 ng/mL. Patients receiving Leutinizing hormone releasing
hormone (LHRH) agonists 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 >60 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.
Have a serum albumin of ≥ 3.0 g/dL

- 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 the 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.

Exclusion Criteria:

- Surgery or radiation therapy within 2 weeks. Cytotoxic anti-cancer therapy within 3
weeks. Non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever
is longer) of Study Day 1.

- Use of an investigational therapeutic 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; 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, hypersensitivity, or intolerance 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

- Serious infection requiring parenteral antibiotics within 14 days of enrollment

- Poorly controlled diabetes (HgbA1C >9)

- Active or symptomatic viral hepatitis or chronic 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. Use of flutamide within 4 weeks of study dosing with a continued rise
in PSA.

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy of Cabazitaxel in combination with Abiraterone acetate and Prednisone

Outcome Description:

Phase I dose escalation portion: To determine the maximum tolerated dose, dose limiting toxicities, safety, and recommended phase 2 dose of cabazitaxel, administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily, to patients with castrate-resistant prostate cancer. Phase II portion: To assess the anti-cancer efficacy of the combination in patients with Castrate Resistant Prostate Cance (CRPC), as determined by a prostatic specific antigen (PSA) decline of 50% or more from baseline during the first 6 cycles (18 weeks), measured every 3 weeks while on study.

Outcome Time Frame:

Every 3 weeks for duration of study treatment

Safety Issue:


Principal Investigator

Elaine Lam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Institutional Review Board

Study ID:



Start Date:

July 2013

Completion Date:

July 2019

Related Keywords:

  • Prostate Cancer
  • Metastatic Castrate Resistant Prostate Cancer
  • Prostatic Neoplasms



University of Colorado Cancer CenterDenver, Colorado  80262