Safety and Efficacy of Cabazitaxel in Pediatric Patients with RefractorySolid Tumors Including Central Nervous System Tumors

Active, not recruiting

• Conditions: Cancer; MedDRA version: 18.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10061268Term: Malignant nervous system neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002184-42-Outside-EU/EEA
• Lead Sponsor: Sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-19
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Phase 1 Part (dose escalation):

Patients with a histologically confirmed
solid tumor including tumors of the central nervous system that is
recurrent or refractory and for which no further effective standard
treatment is available. All patients must have measurable disease.
Patients with diffuse pontine glioma are eligible without a biopsy after
evidence of progressive disease post radiation therapy.

Phase 2 Part (safety and activity):

Patients with recurrent or refractory
high grade glioma or diffuse intrinsic pontine glioma for whom no
further effective therapy is available. All patients must have
measurable disease. Patients with diffuse pontine glioma are eligible
without a biopsy after evidence of progressive disease post radiation
therapy. Patients with a grade III or grade IV glioma must have
pathologic conformation either at the time of initial diagnosis or at the
time of recurrence.
Patients aged =2 years and =18 years
Patients should meet the body surface area (BSA) requirements to be
eligible:
a) Minimal BSA requirements for a particular dose level;
b) During the Phase 1 part patients must have a BSA <2.1 m² at the
time of enrollment
c) During the Phase 2 part patients with a BSA =2.1 m² will be eligible,
however the actual dose of cabazitaxel for these patients will be
adjusted to a maximum dose calculated with (capped at) the BSA of 2.1
m²
Performance status by:
a) Lansky score =60 (patients =10 years of age)
b) Karnofsky score =60% (patients >10 years of age)
Patients who are unable to walk because of paralysis, but who are
mobile in a wheelchair, will be considered ambulatory for the purpose
of assessing the performance score
Patients must have adequate liver, renal and marrow function as
defined below:
a) Total bilirubin =1.0 x the upper limit of normal (ULN) for age
b) AST (SGOT) and ALT (SGPT) =2.5 x ULN
c) Serum creatinine =1.5 x ULN for age or creatinine clearance =60
mL/min/1.73 m²
d) Absolute neutrophil count =1.0x10^9 /L
e) Platelets =75x10^9/L (transfusion independent)
f) Hemoglobin =8.0 g/dL (can be transfused)
Female patients of child-bearing potential must have a negative
pregnancy test =7 days before starting cabazitaxel treatment.
Male and female patients of reproductive potential must agree to use
adequate contraception prior to study entry, for the duration of study
participation and for 6 months following the last dose of cabazitaxel.
Written informed consent/assent prior to any study-specific
procedures. Consent must be obtained from the patient and/or
parent(s) or legal guardian(s) and the signature of at least one parent or guardian will be required. Investigators will also obtain assent of
patients according to local, regional or national guidelines.
Patients must have recovered from the acute toxic effects of all prior
therapy to = grade 1before entering the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 57
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior treatment within the following timeframes:
a) Systemic anti-cancer treatment within 3 weeks (6 weeks for
nitrosourea, mitomycin and monoclonal antibodies including
bevacizumab)
b) Surgery or smaller field radiation therapy within 4 weeks
c) Treatment with an investigational agent within 4 weeks or within 5
half-lives of the agent, whichever is longer
Craniospinal or other large field radiation therapy (defined as >25% of
bone marrow irradiated) within 6 months prior to the first dose.
Prior systemic radioisotope therapy (this does not include diagnostic
imaging or radioimmunoconjugates lacking myelosuppressive
properties) or total body irradiation.
Prior bone marrow or stem cell transplant
Patients with any clinically significant illness that, in the investigator's
opinion, cannot be adequately controlled with appropriate therapy,
would compromise a patient's ability to tolerate cabazitaxel or result in
inability to assess toxicity. This includes, but is not limited to
uncontrolled intercurrent illness including ongoing or active infection,
cardiac disease, renal impairment, planned surgery or psychiatric
illness/social situations that would limit compliance with study
requirements.
Known human immunodeficiency virus (HIV) infection or acquired
immunodeficiency-syndrome (AIDS)-related disease
Known history of hepatitis C or known active hepatitis B infection.
Pregnant or breast feeding women
Treatment with strong inhibitors or strong inducers of CYP3A4 or
enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to
first dose of cabazitaxel and for the duration of study. Non-EIAEDs are
permitted.
Known history of hypersensitivity to taxanes or polysorbate 80 or GCSF.
Participation in another interventional clinical trial and/or concurrent
treatment with any investigational drug.
Patients not able to comply with scheduled visits, treatment plans,
laboratory tests, and other study procédures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified