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An Efficacy Study Of Ortataxel In Recurrent Glioblastoma (Ortataxel)

Primary Purpose

Glioblastoma

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Ortataxel

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Surgery must have confirmed the recurrence.
2. 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.
3. 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.

Exclusion Criteria:

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

Sites / Locations

Ospedale di Lecco
A.O. OSpedale Niguarda Ca' Granda
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Carlo Besta Neurological Foundation
Fondazione "Salvatore Maugeri"
IRCCS Fondazione "Casimiro Mondino"
Istituti Fisioterapici Ospitalieri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ortataxel

Arm Description

75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)

Outcomes

Primary Outcome Measures

progression free survival-6

defined as the percentage of patients who are alive and progression free at 6 months after the randomization

Secondary Outcome Measures

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

Overall survival-9

defined as the percentage of patients who are alive at 9 months after the 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

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).

treatment compliance

-Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals

Full Information

NCT ID

NCT01989884

First Posted

October 23, 2013

Last Updated

October 21, 2019

Sponsor

Mario Negri Institute for Pharmacological Research

1. Study Identification

Unique Protocol Identification Number

NCT01989884

Brief Title

An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Acronym

Ortataxel

Official Title

Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ortataxel

Arm Type

Experimental

Arm Description

75 on day 1 every 21 days mg/m2 milligram(s)/square meter (intravenous use)

Intervention Type

Drug

Intervention Name(s)

Ortataxel

Other Intervention Name(s)

IDN5109

Intervention Description

75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.

Primary Outcome Measure Information:

Title

progression free survival-6

Description

defined as the percentage of patients who are alive and progression free at 6 months after the randomization

Time Frame

after 6 months after randomization

Secondary Outcome Measure Information:

Title

progression free survival

Description

Time Frame

after 9 months of follow-up for each patient

Title

Overall survival-9

Description

defined as the percentage of patients who are alive at 9 months after the randomization.

Time Frame

9 months after randomization

Title

Objective response rate

Description

defined as the percentage of patients who are judged by the Investigators to have an objective response as determined by the RANO criteria

Time Frame

after 9 months of follow-up for each patient

Title

Number of patients with AEs, SAEs, SADRs, SUSARs

Description

Time Frame

after 9 months of follow-up for each patient

Title

treatment compliance

Description

-Dose-intensity, -percentage of patients with dose and/or time modifications, - Percentage of premature withdrawals

Time Frame

9 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Silvani, MD

Organizational Affiliation

Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale di Lecco

City

Lecco

Country

Italy

Facility Name

A.O. OSpedale Niguarda Ca' Granda

City

Milano

Country

Italy

Facility Name

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

City

Milano

Country

Italy

Facility Name

Carlo Besta Neurological Foundation

City

Milan

ZIP/Postal Code

20133

Country

Italy

Facility Name

Fondazione "Salvatore Maugeri"

City

Pavia

Country

Italy

Facility Name

IRCCS Fondazione "Casimiro Mondino"

City

Pavia

Country

Italy

Facility Name

Istituti Fisioterapici Ospitalieri

City

Rome

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

30726533

Citation

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.

Results Reference

result

Links:

URL

https://doi.org/10.1007/s11060-019-03116-z

Description

journal article

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://doi.org/10.1007/s11060-019-03116-z

Learn more about this trial

An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

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