Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

IDN 5109

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

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

Ortataxel

Antonio Silvani, MD

Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma

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).

An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

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

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

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

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

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

* 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).

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

Mario Negri Institute for Pharmacological Research

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Infections

Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Aggression

Burkitt Lymphoma

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Diffuse Large B-Cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Lymphoma, Large-cell, Immunoblastic

ortataxel

Rasim Ahmet Gucalp, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862.
* Determine the overall survival in patients treated with this drug.
* Determine the time to progression in patients treated with this drug.
* Determine the duration of response (CR and PR) in patients treated with this drug.
* Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
* Determine the pharmacokinetic profile of this drug in selected patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

Theradex

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Efficacy Study Of Ortataxel In Recurrent Glioblastoma	NCT01989884	Glioblastoma	Ortataxel	18 Years -	Mario Negri Institute for Pharmacological Research
An Efficacy Study Of Ortataxel In Recurrent Glioblastoma	NCT01989884	Glioblastoma	Ortataxel	18 Years -	Mario Negri Institute for Pharmacological Research
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma	NCT00039156	Lymphoma	ortataxel	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for ortataxel

Every month we try and update this database with for ortataxel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ortataxel

Every month we try and update this database with for ortataxel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ortataxel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.