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Trial record 1 of 1 for:    cabazl07239
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Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer (PEGAZUS)

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ClinicalTrials.gov Identifier: NCT02441894
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To assess the tolerability of cabazitaxel 25 mg per body surface area (m^2) with primary prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count [ANC] <1000 per volume [mm^3] and a single temperature of >38.3 degree or a sustained temperature of ≥38 degree Celsius for more than one hour) during Cycle 1.

Secondary Objective:

To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CABAZITAXEL XRP6258 Drug: PEG-G-CSF Drug: Prednisolone Drug: Dexchlorpheniramine or Diphenhydramine Drug: Ranitidine Drug: Metoclopramide, Granisetron, or Ondansetron Drug: Dexamethasone Phase 4

Detailed Description:
The total duration of study is 254 days as maximum with 14 days for screening, maximum of 21 days times 10 cycles for treatment, and 30 days for follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Study Start Date : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Cabazitaxel

25 mg/m^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks.

Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles.

Drug: CABAZITAXEL XRP6258
Pharmaceutical form:solution Route of administration: intravenous
Other Name: JEVTANA

Drug: PEG-G-CSF
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: G-LASTA

Drug: Prednisolone
Pharmaceutical form:tablet Route of administration: oral

Drug: Dexchlorpheniramine or Diphenhydramine
Pharmaceutical form:tablet, powder, or solution Route of administration: oral, intravenous or intramuscular

Drug: Ranitidine
Pharmaceutical form:tablet or solution Route of administration: oral, intravenous or intramuscular

Drug: Metoclopramide, Granisetron, or Ondansetron
Pharmaceutical form:tablet, powder, jelly, or solution Route of administration: oral, intravenous or intramuscular

Drug: Dexamethasone
Pharmaceutical form:tablet, capsule, or solution Route of administration: oral or intravenous




Primary Outcome Measures :
  1. Number of patients with FN (all grades) during study Cycle 1 [ Time Frame: 3 weeks (during study Cycle 1) ]

Secondary Outcome Measures :
  1. Number of patients with FN (all grades) [ Time Frame: Up to 7 months as treatment period ]
  2. Number of patients with Grade ≥3 neutropenia [ Time Frame: Up to 7 months as treatment period ]
  3. Number of patients with Grade ≥3 diarrhea [ Time Frame: Up to 7 months as treatment period ]
  4. Number of dose delays in the start of drug administration due to AEs [ Time Frame: Up to 7 months as treatment period ]
  5. Number of dose reductions due to AEs [ Time Frame: Up to 7 months as treatment period ]
  6. Percent change in relative dose intensity due to AEs [ Time Frame: Up to 7 months as treatment period ]
  7. Number of patients with FN-related hospitalization [ Time Frame: Up to 7 months as treatment period ]
  8. Number of patients who used IV anti-infective drugs [ Time Frame: Up to 7 months as treatment period ]
  9. Changes of PSA levels from baseline [ Time Frame: Up to 7 months as treatment period ]
  10. Number of patients with adverse events [ Time Frame: Up to 7 months as treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with chemotherapy including docetaxel.
  • Male patients.
  • Patients must have either measurable or nonmeasurable disease, or documented rising PSA levels.
  • Patients signed informed consent.

Exclusion criteria:

  • Age <20 at registration.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2.
  • Inadequate organ and bone marrow function at registration as evidenced by:

    • Hemoglobin <10.0 g/dL.
    • ANC <5 x 10^9/L.
    • Platelet count <100 x 10^9/L.
    • Aspartate transaminase (AST) and/or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN).
    • Total bilirubin >1.0 x ULN.
    • Serum creatinine >1.5 x ULN. Serum creatinine is 1.0-1.5 x ULN and creatinine clearance is under 60 mL/min (calculated according to Chronic Kidney Disease Epidemiology Collaboration [CKD-EP]).
  • Prior isotope therapy or radiotherapy to ≥30% of bone marrow. At the first study drug administration day, patient has not elapsed 8 weeks (12 weeks for strontium-89) from the day prior isotope therapy finished.
  • Prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks prior to enrollment in the study.
  • Symptomatic peripheral neuropathy grade ≥2 (NCI CTCAE v.4.0).
  • History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs.
  • Prior and other concurrent malignancy, excepted cases are as follows; basal cell carcinoma or squamous cell carcinoma of skin, or superficial (pTis, pTa, and pT1) bladder cancer (including immunotherapy) treated adequately, any other cancer completed the chemotherapy more than 5 years ago and been more than 5 years as disease free duration.
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus).
  • Known lesion at brain or leptomeninx.
  • Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
  • Active varicella zoster infection, anti-hepatitis C virus (HCV) antibody-positive (excluding patients negative for HCV virus in blood test or non-active seropositive patients with no hepatic abnormalities [AST, ALT, etc.]), or hepatitis B surface (HBs) antigen-positive.
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 or 5 (wash-out period for a one week is necessary for patients who are already on these treatments or a two-week wash-out period is necessary for patients who are already on these treatments).
  • Contraindication to be used corticosteroid.
  • Patients with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" will be based on the Investigator's judgment.
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to registration.
  • Prior history of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisolone, PEG-G-CSF or G-CSF.
  • Known hypersensitivity to the component of PEG-G-CSF and/or G-CSF.
  • Myelogenous leukemia insufficient decrease of the number of blast in bone marrow, or found myeloblast in peripheral blood.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441894


Locations
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Japan
Investigational Site Number 392004
Chuo-ku, Chiba, Japan
Investigational Site Number 392008
Kita-gun, Japan
Investigational Site Number 392007
Kobe-shi, Hyogo, Japan
Investigational Site Number 392005
Nagakute-shi, Aichi, Japan
Investigational Site Number 392006
Osaka Sayama-shi, Osaka, Japan
Investigational Site Number 392001
Shinjuku-ku, Tokyo, Japan
Investigational Site Number 392002
Yokohama-shi, Kanagawa, Japan
Investigational Site Number 392009
Yokohama-shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02441894     History of Changes
Other Study ID Numbers: CABAZL07239
U1111-1155-8055 ( UTN )
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Ondansetron
Diphenhydramine
Metoclopramide
Granisetron
Prednisolone hemisuccinate
Prednisolone phosphate
Ranitidine
Ranitidine bismuth citrate
BB 1101
Lenograstim
Promethazine
Chlorpheniramine
Dexchlorpheniramine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents