GlioblastomaPhase 2OrtataxelNCT01989884
An Efficacy Study Of Ortataxel In Recurrent Glioblastoma
A Phase 2 study testing Ortataxel in people with Glioblastoma, run by Mario Negri Institute for Pharmacological Research at 7 sites in Italy.
Trial summary
Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ortataxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesItaly
- Study dates
- Nov 2013to Dec 2016
- 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
- Histologically confirmed GBM.
- GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
- Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
- No more than one prior line of chemotherapy (Temozolomide).
- Recovery from the toxic effects of prior therapy.
- Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
Show all 13Show fewer
- Surgery must have confirmed the recurrence.
- A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
- Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration.
- Age ≥ 18 years.
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
- Karnofsky-PS ≥ 60%.
- Stable or decreasing dose of corticosteroids within 5 days prior to registration.
Who cannot join
- Patients unable to undergo brain MRI scans with gadolinium (iv).
- Pre-existing peripheral neuropathy, grade ≥ 2.
- History of intracranial abscess within 6 months prior to registration.
- Anticipation of need for major surgical procedure during the course of the trial.
- Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Ospedale di Lecco
Lecco
Carlo Besta Neurological Foundation
Milan, 20133
A.O. OSpedale Niguarda Ca' Granda
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Fondazione "Salvatore Maugeri"
Pavia
IRCCS Fondazione "Casimiro Mondino"
Pavia
Istituti Fisioterapici Ospitalieri
Rome
About this study
Official title: Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Read the detailed description
In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).
- Conditions
- Glioblastoma
- Being tested
- Ortataxel
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrtataxelDrug
Also called IDN5109
75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Ortataxel | Experimental | 75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use) Receives: Drug: Ortataxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival-6
defined as the percentage of patients who are alive and progression free at 6 months after the randomization
Measured: after 6 months after randomization
Secondary outcomes (5)
progression free survival
defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death from any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date
Measured: after 9 months of follow-up for each patient
Overall survival-9
defined as the percentage of patients who are alive at 9 months after the randomization.
Measured: 9 months after randomization
Objective response rate
defined as the percentage of patients who are judged by the Investigators to have an objective response as determined by the RANO criteria
Measured: after 9 months of follow-up for each patient
Number of patients with AEs, SAEs, SADRs, SUSARs
- Incidence, nature, severity and seriousness of AEs, according of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
- Maximum toxicity grade experienced by each patient for each specific toxicity
- Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity
- Patients with at least a SAE
- Patients with at least a serious adverse drug reaction (SADR)
- Patients with at least a suspect unexpected serious adverse reaction (SUSAR).
Measured: after 9 months of follow-up for each patient
treatment compliance
-Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals
Measured: 9 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Silvani, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989884
- Sponsor's protocol ID
- IRFMN-GBM-6272
- Acronym
- Ortataxel
- Status last verified
- Nov 2014
- First submitted
- 23 Oct 2013
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Silvani A, De Simone I, Fregoni V, Biagioli E, Marchioni E, Caroli M, Salmaggi A, Pace A, Torri V, Gaviani P, Quaquarini E, Simonetti G, Rulli E, D'Incalci M; Italian Association of Neuro-Oncology. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma. J Neurooncol. 2019 May;142(3):455-462. doi: 10.1007/s11060-019-03116-z. Epub 2019 Feb 6.
PubMed 30726533
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT01989884
- Acronym / sponsor ID
- Ortataxel / IRFMN-GBM-6272
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Nov 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.
Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma
Detailed description
In this phase II study, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. Patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (PFS-6).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ortataxel | Experimental | Drug: Ortataxel75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed GBM.
- GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
- Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
- No more than one prior line of chemotherapy (Temozolomide).
- Recovery from the toxic effects of prior therapy.
Key exclusion criteria (5 listed)
- Patients unable to undergo brain MRI scans with gadolinium (iv).
- Pre-existing peripheral neuropathy, grade ≥ 2.
- History of intracranial abscess within 6 months prior to registration.
- Anticipation of need for major surgical procedure during the course of the trial.
- Treatment with enzyme inducing antiepileptic agents was not allowed. However, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period
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 |
|---|---|---|
| OrtataxelAlso: IDN510975 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Ortataxel |
Primary outcome
progression free survival-6
Time frame: after 6 months after randomization
defined as the percentage of patients who are alive and progression free at 6 months after the randomization
5 secondary outcomes
progression free survival
Time frame: after 9 months of follow-up for each patient
Overall survival-9
Time frame: 9 months after randomization
Objective response rate
Time frame: after 9 months of follow-up for each patient
Number of patients with AEs, SAEs, SADRs, SUSARs
Time frame: after 9 months of follow-up for each patient
treatment compliance
Time frame: 9 months after randomization
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 23 Oct 2019.
- Results publication: PubMed 30726533Silvani A, De Simone I, Fregoni V, Biagioli E, Marchioni E, Caroli M, Salmaggi A, Pace A, Torri V, Gaviani P, Quaquarini E, Simonetti G, Rulli E, D'Incalci M; Italian Association of Neuro-Oncology. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma. J Neurooncol. 2019 May;142(3):455-462. doi: 10.1007/s11060-019-03116-z. Epub 2019 Feb 6.
- journal articleLink provided by the sponsor.
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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.
Antonio Silvani, MD principal investigator
Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
7 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 Ortataxel in people with Glioblastoma, run by Mario Negri Institute for Pharmacological Research at 7 sites in Italy.
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 13 inclusion and 5 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
progression free survival-6 (time frame: after 6 months after randomization). 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 NCT01989884, 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 23 Oct 2019.