This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

NCT00087061

Brain and Central Nervous System Tumors

COMPLETED PHASE1/PHASE2

RO4929097 in Treating Patients With Recurrent Invasive Gliomas

NCT01269411

Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Giant Cell Glioblastoma +4 more

TERMINATED PHASE1

Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme

NCT00005826

Brain and Central Nervous System Tumors

COMPLETED PHASE2

RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

NCT01119599

Acoustic Schwannoma Adult Anaplastic (Malignant) Meningioma Adult Anaplastic Astrocytoma +26 more

COMPLETED PHASE1

Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

NCT00074607

Meningitis Neoplasms

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gimatecan® (ST 1481)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed diagnosis of a recurrent primary malignant glioma
* Life expectancy of at least 3 months with normal hematological, liver and renal function

Exclusion Criteria

* Pregnant and lactating patients
* Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
* Gastrointestinal dysfunction that could alter absorption or motility

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No