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An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

NCT ID: NCT00441610

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gimatecan

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 completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion Criteria

* Documented progressive disease as defined by the core protocol
* Patients with performance status of 3 or 4 on the ECOG scale
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, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3946

Results for CLBQ707A1101E1 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLBQ707A1101E1

Identifier Type: -

Identifier Source: org_study_id