Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Concurrent Versus Sequential Treatment With Sipuleucel-T and Abiraterone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01487863
First received: December 6, 2011
Last updated: February 20, 2014
Last verified: February 2013

December 6, 2011
February 20, 2014
December 2011
July 2015   (final data collection date for primary outcome measure)
Evaluate cumulative sipuleucel-T CD54 upregulation [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487863 on ClinicalTrials.gov Archive Site
  • Evaluate sipuleucel-T product parameters [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ] [ Designated as safety issue: No ]
    To evaluate sipuleucel-T product parameters of cumulative CD54+ cell count and total nucleated cell count
  • Evaluate the peripheral immune response to sipuleucel-T [ Time Frame: From baseline through 26 weeks ] [ Designated as safety issue: No ]
    Peripheral immune responses to sipuleucel-T will be measured, including IFN-gamma production by T cells, T cell proliferation, and antibody production (humoral response) to both PA2024 and PAP
  • Evaluate safety of sipuleucel-T therapy with concurrent or sequential administration of abiraterone acetate plus prednisone [ Time Frame: From registration to 30 days following the last study treatment ] [ Designated as safety issue: Yes ]
    Safety will be assessed by evaluation of adverse events, laboratory tests, vital signs, ECOG performance status, and physical examinations
Same as current
Not Provided
Not Provided
 
Concurrent Versus Sequential Treatment With Sipuleucel-T and Abiraterone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Prostate Cancer Metastatic
  • Hormone Refractory Prostate Cancer
  • Biological: sipuleucel-T
    Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
    Other Names:
    • PROVENGE(R)
    • APC8015
  • Drug: abiraterone acetate
    Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.
    Other Name: ZYTIGA(R)
  • Experimental: Concurrent Arm
    Subjects will receive sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment will start the next day after the first infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
    Interventions:
    • Biological: sipuleucel-T
    • Drug: abiraterone acetate
  • Experimental: Sequential Arm
    Subjects will receive sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone will start 6 weeks after the last infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
    Interventions:
    • Biological: sipuleucel-T
    • Drug: abiraterone acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • historically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
  • metastatic status as evidenced by imaging obtained </= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
  • castrate resistant prostate cancer: castrate levels of testosterone (</= 50 ng/dL; evidence of disease progression concomitant with surgical or medical castration
  • serum PSA >/= 2.0 ng/mL
  • castrate levels of testosterone (</= 50 ng/dL) achieved via medical or surgical castration
  • baseline ECOG performance status of </= 1
  • systolic blood pressure (BP) </= 140 mm HG and diastolic BP </= 90 mm Hg at screening
  • adequate baseline hematologic, renal, and liver functions
  • must live in a permanent residence within a comfortable driving distance (roundtrip within one day) of the clinical trial site

Exclusion Criteria:

  • the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
  • New York Heart Association Class III or IV heart failure
  • any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
  • Child-Pugh Class B or C hepatic insufficiency
  • spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
  • known adrenalcortical insufficiency
  • any medical contraindications to receiving prednisone
  • prior treatment with sipuleucel-T
  • previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))
  • a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled, intra-nasal, intra-articular, and topical steroids is allowed.
  • treatment with any investigational vaccine or immunotherapy
  • a history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
  • myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to registration
  • ongoing anti-androgen withdrawal response.
  • systemic steroid use within ≤ 60 days of registration
  • treatment with denosumab (Xgeva(R) or Prolia (R)) within ≤ 3 months prior to registration
  • positive test for HIV or HTLV infections. Subjects with a positive test for hepatitis B or hepatitis C are allowed provided they meet the LFT criteria and have no signs of acute infection or active disease.
  • treatment with any of the following medications or interventions within 28 days prior to registration: external beam radiation or major surgery requiring general anesthetic; saw palmetto; megestrol acetate (Megace(R)), diethylstilbestrol, and cyproterone; 5-alpha-reductase inhibitors (e.g. finasteride [Proscar(R)], dutasteride [Avodart(R)]); steroidal anti-androgen therapy; any other systemic therapy for prostate cancer, except for medical castration; treatment with any other investigational product for prostate cancer; substrates of CYP2D6 (e.g. including but not limited to thioridazine); inhibitors of CYP3A4 (e.g. including but not limited to ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and voriconazole); inducers of CYP3A4 (e.g. including but not limited to phenytoin, carbamazepine, rifampin, rifapentine, and phenobarbital)
  • a requirement for treatment with opioid analgesics within 21 days prior to registration
  • an active infection or infection requiring parenteral antibiotic therapy or causing fever within 7 days of registration
  • any medical intervention, or other condition, or any other circumstance that, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487863
P11-3
No
Dendreon
Dendreon
Not Provided
Study Director: Andrew C Stubbs, PhD Dendreon
Dendreon
February 2013

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