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Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme (GBM) WHO Grade IV

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Trial Information

Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -

Inclusion Criteria:

- Both female and male patients meeting the mentioned inclusion and exclusion criteria
will be included in this clinical trial. Patients must meet ALL of the following
inclusion criteria to be eligible for enrollment into the study:

- Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV
(histologically confirmed by a pathologist)

- Progression during or within 6 months after last temozolomide treatment

- Time since last temozolomide > 21 days

- Prior external beam radiotherapy (54 to 62 Gy), no option for subsequent

- No clinical and radiological signs of intracerebral inflammation (in pre-study
MRI not older than 4 weeks)

- Patients > 18 years of age.

- ECOG performance status of ≤ 2

- Female patients of childbearing potential with a negative pregnancy test within
7 days of initiation of study treatment. Postmenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing

- Male and female patients of reproductive potential who agree to employ an
effective method of birth control throughout the study and for up to 6 months
following discontinuation of study drug.

- Signed informed consent prior to initiation of any study procedure

Exclusion Criteria:

- The presence of ANY of the following criteria will exclude a patient from study

- Female patients who are pregnant or breast-feeding

- History of severe hypersensitivity reaction (≥grade 3) to any component of the
investigational drugs or excipients (allergy to or other intolerability of
gadolinium, docetaxel, cabazitaxel or polysorbate 80 containing drugs)

- Unable to undergo Gd-MRI

- Time since external beam radiotherapy <12 weeks

- Patients who have been treated with any investigational agent(s) within 28 days
of the first day of administration of study drug.

- Current active second malignancy other than non-melanoma skin cancers and
post-treatment of localized prostate cancer. Patients are not considered to have
a currently active malignancy if they are in complete remission for > 3 years
prior to study

- Uncontrolled severe illness or medical condition (including uncontrolled
diabetes mellitus)

- Known HIV infection, active Hepatitis B or C infection

- Any serious and/or unstable pre-existing psychiatric or other condition that
could interfere with subject's safety, provision of informed consent, or
compliance to study procedures

- Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or
that is progressing in severity (except alopecia) and delayed hematological
recovery following last temozolomide cycle

- Additional anti-cancer treatment for GBM other than study drug and supportive
measures (i.e. dexamethasone)

- Inadequate organ and bone marrow function as evidenced by:

1. Hemoglobin <9.0 g/dL

2. Absolute neutrophil count <1.5 x 109/L,

3. Platelet count <100 x 109/L,

4. AST/SGOT and/or ALT/SGPT >2.5 x ULN;

5. Total bilirubin >1.0 x ULN,

6. Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine
clearance will be calculated according to CKD-EPI formula and patients with
creatinine clearance <60 mL/min should be excluded

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response including SD, PR or CR determined by MRI (modified RANO criteria)

Outcome Description:

• Response after 12 weeks

Outcome Time Frame:

1 year

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:

C-GBM (XRP6258)



Start Date:

July 2013

Completion Date:

December 2016

Related Keywords:

  • Glioblastoma Multiforme (GBM) WHO Grade IV
  • Glioblastoma