NCT00397072

Brief Summary

The purpose of this single arm phase II study is to evaluate safety and efficacy of ZK 219477 in the treatment of temozolomide pre-treated, recurrent GBM patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

November 7, 2006

Last Update Submit

April 16, 2014

Conditions

Glioblastoma

Keywords

Glioblastoma recurrent,temozolomide, epothilone

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival at six months (PFS-6).

    6 months

Secondary Outcomes (3)

  • Response rates (CR +PR)

    2 years

  • Safety evaluation according to CTC-AE

    2 years

  • Median Survival Time (MST)

    2 years

Study Arms (1)

ZK-EPO

EXPERIMENTAL

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.

Drug: ZK 219477

Interventions

ZK 219477DRUG
ZK-EPO

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale Neurologico

Milan, 20133, Italy

Location

Related Publications (2)

  • Klar U, Buchmann B, Schwede W, Skuballa W, Hoffmann J, Lichtner RB. Total synthesis and antitumor activity of ZK-EPO: the first fully synthetic epothilone in clinical development. Angew Chem Int Ed Engl. 2006 Dec 4;45(47):7942-8. doi: 10.1002/anie.200602785. No abstract available.

    PMID: 17006870BACKGROUND

  • Silvani A, Gaviani P, Fiumani A, Scaioli V, Lamperti E, Eoli M, Botturi A, Salmaggi A. Systemic sagopilone (ZK-EPO) treatment of patients with recurrent malignant gliomas. J Neurooncol. 2009 Oct;95(1):61-64. doi: 10.1007/s11060-009-9890-8. Epub 2009 Apr 21.

    PMID: 19381446RESULT

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Amerigo Boairdi, MD

    Istituto Nazionale Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

IT(1)