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Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218606
Recruitment Status : Active, not recruiting
First Posted : August 18, 2014
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Sanofi
Thomas Jefferson University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 8, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
progression free survival (rPFS) [ Time Frame: 1 year ]
using the RECIST criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
  • PSA progression free survival (PSA PFS) [ Time Frame: 1 year ]
    For each patient, use a waterfall plot to report the percent change in PSA from baseline to 12 weeks (or earlier for those who discontinue therapy) and the maximum decline in PSA that occurs at any point after treatment.
  • objective response rate (ORR) [ Time Frame: 1 year ]
    per RECIST criteria
  • toxicity [ Time Frame: 1 year ]
    The NCI CTCAE version 4.0 will be used for recording and grading AEs.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
  • PSA progression free survival (PSA PFS) [ Time Frame: 1 year ]
    For each patient, use a waterfall plot to report the percent change in PSA from baseline to 12 weeks (or earlier for those who discontinue therapy) and the maximum decline in PSA that occurs at any point after treatment.
  • objective response rate (ORR) [ Time Frame: 1 year ]
    per RECIST criteria
  • toxicity [ Time Frame: 1 year ]
    The NCI CTCAE v4.0 will be used for recording and grading AEs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
Official Title  ICMJE An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
Brief Summary The purpose of this study is to see what effects (good and bad) treatment with abiraterone acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a chemotherapy) have on the cancer and to find out more about whether specific laboratory tests on tumor are useful in predicting how the patient will respond to treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Abiraterone acetate 1000 mg po daily
  • Drug: Cabazitaxel 25 mg/m2 IV
  • Drug: prednisone 5 mg po BID
Study Arms  ICMJE
  • Experimental: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
    Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
    Interventions:
    • Drug: Abiraterone acetate 1000 mg po daily
    • Drug: prednisone 5 mg po BID
  • Experimental: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily
    Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
    Interventions:
    • Drug: Abiraterone acetate 1000 mg po daily
    • Drug: Cabazitaxel 25 mg/m2 IV
    • Drug: prednisone 5 mg po BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2014)
25
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient needs to have a histologic or cytologic diagnosis of prostate cancer

Documented progressive metastatic CRPC based on at least one of the following criteria:

  1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
  2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
  3. Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.

    • Agree to undergo a biopsy of at least one metastatic site or primary prostate for determination of the RB status. Adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC (within 6 months of treatment start).
    • ECOG performance status of 0-2.
    • Age ≥ 18 years.
    • Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
    • Patients on long term (>6 months) anti-androgen therapy (e.g. flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required).
    • Patients must have adequate organ and marrow function as defined below obtained within 14 days prior to treatment start:
    • ANC >=1,500/μl
    • Hemoglobin >=9g/dL
    • Platelet count >=100,000/μl
    • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
    • Potassium > 3.5 mmol/L (within institutional normal range)
    • Bilirubin ≤ ULN (unless documented Gilbert's disease)
    • SGOT (AST) <=2.5 x ULN
    • SGPT (ALT) <=2.5 x ULN
    • The effects of cabazitaxel and abiraterone acetate on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to study entry, for the duration of study participation and for at least 3 months thereafter.
    • Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
    • Patients may have received prior radiation therapy or major surgery. However, at least 21 days prior to treatment start must have elapsed since completion of radiation therapy or major surgery and patient must have recovered from all side effects at the time of randomization.
    • Ability to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents. Any prior investigational therapeutic products must be stopped at least 28 days (4 week washout) prior to treatment start.
  • No prior exposure to abiraterone acetate or other specific CYP-17 inhibitors.
  • No prior chemotherapy regimen. Prior isotope therapy with Strontium-89, Samarium or RAD223 should be completed at least three months (12 weeks) prior to treatment start.
  • No ≥ grade 2 peripheral neuropathy
  • Patients who have had antifungal agents (itraconazole, fluconazole) within 4 weeks prior to treatment start or those who have not recovered from AEs due to these agents administered more than 4 weeks earlier.
  • Patients with a history of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease are not eligible.
  • Patients with known symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabazitaxel or other drugs formulated with polysorbate 80; or abiraterone acetate.
  • Patients may continue on a daily Multi-Vitamin, calcium and Vitamin D, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before treatment start. Patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery for their prostate cancer, or radiation therapy during protocol treatment.
  • Patients on stable doses of bisphosphonates or the RANK-L inhibitor, Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218606
Other Study ID Numbers  ICMJE 14-046
PCCTC LOI: c12-108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Sanofi
  • Thomas Jefferson University
  • Weill Medical College of Cornell University
Investigators  ICMJE
Principal Investigator: Susan Slovin, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP