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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gimatecan® (ST-1481)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No