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

NCT02218606 | Completed Phase 2 Results DMC

• 2 other identifiers: 14-046PCCTC LOI: c12-108
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Keywords

Abiraterone Acetate; CABAZITAXEL; CASTRATION RESISTANT; 14-046; Prostate Cancer Clinical Trials Consortium

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (rPFS)

  using the RECIST criteria

  Up to 100 weeks

Secondary Outcomes (3)

• PSA Progression Free Survival (PSA PFS)

  Up to 100 weeks

• Objective Response Rate (ORR)

  1 year

• Participants With Maximum Overall Grade ≥3 AEs

  1 year

Study Arms (2)

Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID

EXPERIMENTAL

Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID

Drug: Abiraterone acetate 1000 mg po daily; Drug: prednisone 5 mg po BID

Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily

EXPERIMENTAL

Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID

Drug: Abiraterone acetate 1000 mg po daily; Drug: Cabazitaxel 25 mg/m2 IV; Drug: prednisone 5 mg po BID

Interventions

Abiraterone acetate 1000 mg po daily DRUG

Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID; Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily

Cabazitaxel 25 mg/m2 IV DRUG

Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily

prednisone 5 mg po BID DRUG

Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID; Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily

Eligibility Criteria

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

You may qualify if:

• 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:
• 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.
• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Sanofi: collaborator
• Thomas Jefferson University: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (4)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; cabazitaxel; Prednisone

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; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Dr. Susan Slovin, MD, PhD
• Organization: Memorial Sloan Kettering Cancer Center

slovins@MSKCC.ORG

646-422-4472

Study Officials

• Susan Slovin, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2023-10

Locations

US (4)