- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00420485
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
April 17, 2013 updated by: Novartis Pharmaceuticals
A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Study Overview
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Novartis Investigative Site
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- MD Anderson Cancer Center - Orlando
-
-
-
-
-
Copenhagen, Denmark, DK-2100
- Novartis Investigative Site
-
-
-
-
-
Dijon Cedex, France, 21034
- Novartis Investigative Site
-
Paris, France, 75005
- Novartis Investigative Site
-
Saint-Herblain Cedex, France, 44805
- Novartis Investigative Site
-
Toulouse, France, 31052
- Novartis Investigative Site
-
-
-
-
-
Mainz, Germany, 55101
- Novartis Investigative Site
-
Tubingen, Germany, 72076
- Novartis Investigative Site
-
-
-
-
-
Enschede, Netherlands
- Novartis Investigative Site
-
-
-
-
-
Oslo, Norway, 310
- Novartis Investigative Site
-
-
-
-
-
Madrid, Spain, 28041
- Novartis Investigative Site
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daily times five schedule
|
|
Experimental: Continuous schedule, twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of dose limiting toxicities in a 56-day treatment period
Time Frame: 56 days
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety and tolerability assessed by adverse events, serious adverse events
Time Frame: 112 days
|
112 days
|
pharmacokinetics of gimatecan and its metabolites(s)
Time Frame: 91 days
|
91 days
|
response rate assessed by anti-tumor activity
Time Frame: 112 days
|
112 days
|
investigate tumor-specific mutations
Time Frame: 57 days
|
57 days
|
Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
Time Frame: 56 days
|
56 days
|
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
March 1, 2006
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
January 8, 2007
First Submitted That Met QC Criteria
January 8, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
April 19, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLBQ707A2101
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 Solid Tumors
-
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
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Cancer Institute and Hospital, Chinese Academy...RecruitingRefractory Solid Tumors | Relapsed Solid TumorsChina
-
Genentech, Inc.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsCanada, Korea, Republic of, United States, Brazil, Australia, Argentina, Spain, New Zealand, Poland
Clinical Trials on gimatecan
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Lee's Pharmaceutical LimitedNot yet recruiting
-
M.D. Anderson Cancer CenterNovartisCompletedMyelodysplastic Syndromes | MDSUnited States
-
Lee's Pharmaceutical LimitedNot yet recruitingFallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal Cancer
-
Sigma-Tau Research, Inc.Rhode Island HospitalCompletedMalignant GliomaUnited States
-
NovartisCompleted
-
Novartis PharmaceuticalsCompletedAdvanced Solid TumorsJapan
-
Novartis PharmaceuticalsCompleted
-
Lee's Pharmaceutical LimitedUnknownOvarian Epithelial Cancer | Fallopian Tube Cancer | Primary Peritoneal CancerChina
-
Sigma-Tau Research, Inc.Dana-Farber Cancer Institute; Rhode Island HospitalCompletedSolid MalignanciesUnited States