- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00487058
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors
November 18, 2009 updated by: Novartis
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.
Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
28
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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Saitama Prefecture, Japan
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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 with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists
- Life expectancy of at least 3 months
- No dysfunction of bone marrow
- No major impairment of renal and hepatic function
Exclusion criteria
- Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
- Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
- Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
- Patients known to be HIV, or hepatitis B or C viruses 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 of drugs
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
June 14, 2007
First Submitted That Met QC Criteria
June 14, 2007
First Posted (Estimate)
June 15, 2007
Study Record Updates
Last Update Posted (Estimate)
November 19, 2009
Last Update Submitted That Met QC Criteria
November 18, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLBQ707A1103
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.
Clinical Trials on Advanced Solid Tumors
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
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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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Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
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Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
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Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
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Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
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Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
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Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
Clinical Trials on Gimatecan
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
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Lee's Pharmaceutical LimitedNot yet recruiting
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M.D. Anderson Cancer CenterNovartisCompletedMyelodysplastic Syndromes | MDSUnited States
-
Lee's Pharmaceutical LimitedNot yet recruitingFallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal Cancer
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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
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Novartis PharmaceuticalsCompletedAdvanced Solid TumorsJapan
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Novartis PharmaceuticalsCompleted
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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