Glioblastoma Multiforme (GBM) WHO Grade IVPhase 2NCT01866449
Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme
A Phase 2 study testing Cabazitaxel in people with Glioblastoma Multiforme (GBM) WHO Grade IV, run by University of Ulm at 3 sites in Germany.
Trial summary
The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after last temozolomide treatment (Figure 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme (GBM) WHO Grade IV
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2013to 25 Aug 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 radiotherapy
- No clinical and radiological signs of intracerebral inflammation (in pre-study MRI not older than 4 weeks)
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- Patients > 18 years of age.
- ECOG performance status of ≤ 2 (stable over 4 weeks prior to study entrance)
- 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 potential.
- 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 (Must understand, voluntarily sign the informed consent form and be able to adhere to the study visit schedule and other protocol requirements.)
Who cannot join
- The presence of ANY of the following criteria will exclude a patient from study enrollment:
- 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.
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- 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:
- Hemoglobin <9.0 g/dL
- Absolute neutrophil count <1.5 x 109/L,
- Platelet count <100 x 109/L,
- AST/SGOT and/or ALT/SGPT >1.5 x ULN;
- Total bilirubin >1.0 x ULN,
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Hämatologisch onkologische Praxis
Augsburg, 86150
Stiftungsklinikum Mittelrhein GmbH
Koblenz, 56068
Lars Bullinger, MD
Ulm, 89081
About this study
Official title: Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -
The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after last temozolomide treatment (Figure 1).
Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard concomitant medication (as outlined below):
Read more
- On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m², administered by i.v. route in 1 hour.
- Cycle length for cabazitaxel is 3 weeks (21 days).
- New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3, platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have recovered to baseline.
- A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.
- Patients should come off treatment if treatment delay is more than 2 weeks.
At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v. premedication including:
- An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In case of i.v. antihistamine other than promethazine is not being available, local practice should be followed.
- Corticosteroid (dexamethasone 8mg or equivalent)
- H2 antagonist (ranitidine or equivalent).
- Antiemetic prophylaxis is recommended and can be given orally or intravenously if necessary.
- Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given on day 4 of each treatment cycle as per ASCO and ESMO guidelines.
- Being tested
- Cabazitaxel
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtane
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response including SD, PR or CR determined by MRI (modified RANO criteria)
- Response after 12 weeks
Measured: 1 year
Secondary outcomes (4)
Overall and progression-free survival
Measured: 3 years
Safety and tolerability
- Rates of deaths within 12 weeks
- Hematological and non hematological toxicity grade ≥ 2 according to CTCAE V4.0
Measured: 3 years
Pharmacokinetics data concerning drug interactions (i.e. CYP3A induction)
Pharmacokinetics of cabazitaxel in patients with and without concomitant anticonvulsive medication with respect to induction of CYP3A
Measured: 3 years
Quality of life and neurocognitive functioning
Assessment of quality of life, determined by assessment with EORTC QLQ questionnaires (C30 and BN20), and neurocognitive functioning, determined by repeated standardized measurements using MMSE
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (GBM) WHO Grade IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Bullinger, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866449
- Sponsor's protocol ID
- C-GBM (XRP6258)
- Status last verified
- Sep 2017
- First submitted
- 22 May 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -
- ClinicalTrials.gov ID
- NCT01866449
- Acronym / sponsor ID
- C-GBM (XRP6258)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after last temozolomide treatment (Figure 1).
Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard concomitant medication (as outlined below):
- On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m², administered by i.v. route in 1 hour.
- Cycle length for cabazitaxel is 3 weeks (21 days).
- New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3, platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have recovered to baseline.
- A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.
- Patients should come off treatment if treatment delay is more than 2 weeks.
At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v. premedication including:
- An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In case of i.v. antihistamine other than promethazine is not being available, local practice should be followed.
- Corticosteroid (dexamethasone 8mg or equivalent)
- H2 antagonist (ranitidine or equivalent).
- Antiemetic prophylaxis is recommended and can be given orally or intravenously if necessary.
- Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given on day 4 of each treatment cycle as per ASCO and ESMO guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelCabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (19 listed)
- The presence of ANY of the following criteria will exclude a patient from study enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelAlso: Jevtane | Drug | Cabazitaxel |
Primary outcome
Response including SD, PR or CR determined by MRI (modified RANO criteria)
Time frame: 1 year
• Response after 12 weeks
4 secondary outcomes
Overall and progression-free survival
Time frame: 3 years
Safety and tolerability
Time frame: 3 years
Pharmacokinetics data concerning drug interactions (i.e. CYP3A induction)
Time frame: 3 years
Quality of life and neurocognitive functioning
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Glioblastoma Multiforme (GBM) WHO Grade IV, run by University of Ulm at 3 sites in Germany.
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 11 inclusion and 19 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response including SD, PR or CR determined by MRI (modified RANO criteria) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2017.