- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441610
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
December 16, 2020 updated by: Novartis Pharmaceuticals
An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba, Japan
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Gimatecan
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability assessed by Adverse Events
Time Frame: 2.8 years
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2.8 years
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Anti-tumor activity assessed by RECIST criteria
Time Frame: 2.8 years
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2.8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLBQ707A1101E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
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Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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-
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Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
Clinical Trials on Gimatecan
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Sigma-Tau Research, Inc.Rhode Island HospitalCompletedMalignant GliomaUnited States
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Novartis PharmaceuticalsCompletedSolid TumorsSpain, Canada, France, Denmark, Netherlands, Germany, Norway
-
NovartisCompleted
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Novartis PharmaceuticalsCompletedAdvanced Solid TumorsJapan
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Lee's Pharmaceutical LimitedUnknownOvarian Epithelial Cancer | Fallopian Tube Cancer | Primary Peritoneal CancerChina
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Sigma-Tau Research, Inc.Dana-Farber Cancer Institute; Rhode Island HospitalCompletedSolid MalignanciesUnited States