Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-11-30

Brief Summary

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This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily times five schedule

Group Type EXPERIMENTAL

gimatecan

Intervention Type DRUG

Continuous schedule, twice daily

Group Type EXPERIMENTAL

gimatecan

Intervention Type DRUG

Interventions

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gimatecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced or metastatic cancer
* 18 years and above

Exclusion Criteria

* Previous treatment with 4 or more cycles of carboplatin;
* Previous treatment with 2 or more courses of nitrosourea or mitomycin;
* Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
* Severe and/or uncontrolled medical conditions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No