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

Sigma-Tau Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Glioma

Treatments: Drug: Gimatecan® (ST 1481)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00032903

ST 01-402

Details and patient eligibility

About

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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)