This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor

Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00033202

Enrollment

Registered

2002-04-10

Start date

2002-03-31

Completion date

2005-02-28

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

Solid Malignancies

Keywords

Solid Tumor, 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, 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/cytologically proven advanced solid tumors * 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