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Prostate CancerPhase 4PEGAZUSNCT02441894

Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer

A Phase 4 study testing CABAZITAXEL XRP6258, PEG-G-CSF and Prednisolone in people with Prostate Cancer, run by Sanofi at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CABAZITAXEL XRP6258, PEG-G-CSF and Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
8 sitesJapan
Study dates
Apr 2015to Nov 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Investigational Site Number 392004

    Chuo-ku, Chiba

  • Investigational Site Number 392008

    Kita-gun

  • Investigational Site Number 392007

    Kobe-shi, Hyogo

  • Investigational Site Number 392005

    Nagakute-shi, Aichi

  • Investigational Site Number 392006

    Osaka Sayama-shi, Osaka

  • Investigational Site Number 392001

    Shinjuku-ku, Tokyo

  • Investigational Site Number 392009

    Yokohama

  • Investigational Site Number 392002

    Yokohama-shi, Kanagawa

Other trials in Japan

About this study

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

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.

Read more

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
CABAZITAXEL XRP6258, PEG-G-CSF, Prednisolone, Dexchlorpheniramine or Diphenhydramine, Ranitidine
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABAZITAXEL XRP6258Drug

    Also called JEVTANA

    Pharmaceutical form:solution Route of administration: intravenous

  • PEG-G-CSFDrug

    Also called G-LASTA

    Pharmaceutical form:solution Route of administration: subcutaneous

  • PrednisoloneDrug

    Pharmaceutical form:tablet Route of administration: oral

  • Dexchlorpheniramine or DiphenhydramineDrug

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

  • RanitidineDrug

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

  • Metoclopramide, Granisetron, or OndansetronDrug

    Pharmaceutical form:tablet, powder, jelly, or solution Route of administration: oral, intravenous or intramuscular

  • DexamethasoneDrug

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

Study groups in NCT02441894
Study groupRoleWhat they receive
CabazitaxelExperimental25 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.
Receives: Drug: CABAZITAXEL XRP6258; Drug: PEG-G-CSF; Drug: Prednisolone; Drug: Dexchlorpheniramine or Diphenhydramine; Drug: Ranitidine; Drug: Metoclopramide, Granisetron, or Ondansetron; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with FN (all grades) during study Cycle 1

    Measured: 3 weeks (during study Cycle 1)

Secondary outcomes (10)

  1. Number of patients with FN (all grades)

    Measured: Up to 7 months as treatment period

  2. Number of patients with Grade ≥3 neutropenia

    Measured: Up to 7 months as treatment period

  3. Number of patients with Grade ≥3 diarrhea

    Measured: Up to 7 months as treatment period

  4. Number of dose delays in the start of drug administration due to AEs

    Measured: Up to 7 months as treatment period

  5. Number of dose reductions due to AEs

    Measured: Up to 7 months as treatment period

  6. Percent change in relative dose intensity due to AEs

    Measured: Up to 7 months as treatment period

  7. Number of patients with FN-related hospitalization

    Measured: Up to 7 months as treatment period

  8. Number of patients who used IV anti-infective drugs

    Measured: Up to 7 months as treatment period

  9. Changes of PSA levels from baseline

    Measured: Up to 7 months as treatment period

  10. Number of patients with adverse events

    Measured: Up to 7 months as treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441894
Sponsor's protocol ID
CABAZL07239
Other IDs
U1111-1155-8055
Acronym
PEGAZUS
Status last verified
Jan 2017
First submitted
8 May 2015
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Kosaka T, Uemura H, Sumitomo M, Harada K, Sugimoto M, Hayashi N, Yoshimura K, Fukasawa S, Ecstein-Fraisse E, Sunaga Y, Oya M. Impact of pegfilgrastim as primary prophylaxis for metastatic castration-resistant prostate cancer patients undergoing cabazitaxel treatment: an open-label study in Japan. Jpn J Clin Oncol. 2019 Aug 1;49(8):766-771. doi: 10.1093/jjco/hyz051.

    PubMed 31329922

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CABAZITAXEL XRP6258, PEG-G-CSF and Prednisolone in people with Prostate Cancer, run by Sanofi at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with FN (all grades) during study Cycle 1 (time frame: 3 weeks (during study Cycle 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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