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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00420485 |
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Date of registration:
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08/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
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Scientific title:
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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 |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00420485 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Denmark
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France
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Germany
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Netherlands
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Norway
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Spain
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Solid Tumors
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Intervention(s)
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Drug: gimatecan
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Primary Outcome(s)
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Presence of dose limiting toxicities in a 56-day treatment period
[Time Frame: 56 days]
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Secondary Outcome(s)
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safety and tolerability assessed by adverse events, serious adverse events
[Time Frame: 112 days]
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Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
[Time Frame: 56 days]
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pharmacokinetics of gimatecan and its metabolites(s)
[Time Frame: 91 days]
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response rate assessed by anti-tumor activity
[Time Frame: 112 days]
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investigate tumor-specific mutations
[Time Frame: 57 days]
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Secondary ID(s)
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CLBQ707A2101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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