Clinical Trial Details
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NCT01751308 : Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
PhasePhase 1/Phase 2
AgesMin: 2 Years Max: 18 Years
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:

1. Minimal BSA requirements for a particular dose level;

2. During the Phase 1 part patients must have a BSA <2.1 m² at the time of enrollment

3. 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:

1. Lansky score ?60 (patients ?10 years of age)

2. 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:

1. Total bilirubin ?1.0 x the upper limit of normal (ULN) for age

2. AST (SGOT) and ALT (SGPT) ?2.5 x ULN

3. Serum creatinine ?1.5 x ULN for age or creatinine clearance ?60 mL/min/1.73 m²

4. Absolute neutrophil count ?1.0x10^9 /L

5. Platelets ?75x10^9/L (transfusion independent)

6. 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.

Exclusion criteria:

Prior treatment within the following timeframes:

1. Systemic anti-cancer treatment within 3 weeks (6 weeks for nitrosourea, mitomycin and
monoclonal antibodies including bevacizumab)

2. Surgery or smaller field radiation therapy within 4 weeks

3. 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 G-CSF. Participation in
another interventional clinical trial and/or concurrent treatment with any investigational

Patients not able to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures.

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