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

Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00032903

Enrollment

Registered

2002-04-08

Start date

2002-03-31

Completion date

2005-10-31

Last updated

2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Glioma

Keywords

Malignant Glioma, Camptothecin, Pharmacokinetics

Brief summary

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.

Interventions

DRUGGimatecan® (ST 1481)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026