Epothilone in Recurrent Glioblastoma Patients
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ClinicalTrials.gov Identifier: NCT00397072 |
Recruitment Status :
Completed
First Posted : November 8, 2006
Last Update Posted : April 17, 2014
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Drug: ZK 219477 | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study: Systemic Treatment With iv ZK219477-Epothilone in Recurrent Glioblastoma Patients |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: ZK-EPO
administered iv for 3 h every 21 days; dose reductions to 12 or 9 mg/m2 ZK-EPO were allowed in order to manage any treatment-related toxicity.
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Drug: ZK 219477 |
- Progression Free Survival at six months (PFS-6). [ Time Frame: 6 months ]
- Response rates (CR +PR) [ Time Frame: 2 years ]Secondary end-points
- Safety evaluation according to CTC-AE [ Time Frame: 2 years ]
- Median Survival Time (MST) [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 70 years
- KPS ≥ 70
- Life expectancy of at least 3 months
- Presence of at least one bi-dimensionally measurable lesion on gadolinium (Gd)-enhanced MRI, indicating progressive or recurrent disease at least 8 weeks after standard external-beam radiotherapy
- Recurrence or progression after treatment with radiotherapy and temozolomide. Also patients with residual disease after surgery for recurrent GBM will be included
- Adequate bone marrow reserve (leukocytes ≥ 3,500/ml, ANC ≥ 1,500/ml, platelets ≥100,000/ ml); normal baseline liver (serum bilirubin ≤ 20 /mol/ L), renal (serum creatinine <150 /mol/L) and cardiac function
- Absence of infectious disease, debilitating chronic diseases, and known psychiatric disorders
- Corticosteroid dose stable for at least 1 week
- Adequate recovery from previous surgery, radiation and chemotherapy
- Negative pregnancy test at enrolment in females of child-bearing potential
- Agreement to use highly effective contraception methods in adults of reproductive potential
- Fully informed written consent
Exclusion Criteria:
- Pregnant women
- Patients who have had chemotherapy or radiotherapy within 4 weeks
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZK219477
- Uncontrolled inter current illness including, but not limited, to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-infection
- Any prior treatment with epothilones, other tubulin-targetting as taxanes (e.g. paclitaxel, docetaxel) and vinca alkaloids (e.g. vincristine, vinblastine, vinorelbine)
- Peripheral neuropathy
- Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
- Active infection
- Breast-feeding
- Subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
- Employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397072
Italy | |
Istituto Nazionale Neurologico | |
Milan, Italy, 20133 |
Principal Investigator: | Amerigo Boairdi, MD | Istituto Nazionale Neurologico Carlo Besta |
Publications of Results:
Other Publications:
Responsible Party: | Antonio Silvani, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
ClinicalTrials.gov Identifier: | NCT00397072 History of Changes |
Other Study ID Numbers: |
ZK219477IV |
First Posted: | November 8, 2006 Key Record Dates |
Last Update Posted: | April 17, 2014 |
Last Verified: | April 2014 |
Glioblastoma recurrent,temozolomide, epothilone |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Epothilones Sagopilone Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |