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A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

NCT ID: NCT00410358

Last Updated: 2020-12-19

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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Gimatecan topoisomerase I inhibitor advanced solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBQ707

Group Type EXPERIMENTAL

Gimatecan

Intervention Type DRUG

Interventions

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Gimatecan

Intervention Type DRUG

Other Intervention Names

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LBQ707

Eligibility Criteria

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Inclusion Criteria

* Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.
* Life expectancy of at least 3 months
* Adequate hematological parameters
* No major impairment of renal and hepatic function

Exclusion Criteria

* Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.
* Patients who have received any investigational compound within the past 28 days.
* Patients with other antineoplastic therapy within the last 28 days.
* Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
* Patients with a history of allergies to the camptothecin family drug.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Chiba Prefecture, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3945

Results for CLBQ707A1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLBQ707A1101

Identifier Type: -

Identifier Source: org_study_id