A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493155
First received: June 27, 2007
Last updated: July 15, 2009
Last verified: July 2009
Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | July 15, 2009 | ||||
Start Date ICMJE | |||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Maximum tolerated dose. | ||||
Change History | Complete list of historical versions of study NCT00493155 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Safety: AEs, laboratory parameters. Efficacy: Tumor assessments every 2 cycles of treatment. Pharmacokinetics: plasma levels of R1530; effect of food on pharmacokinetic parameters. | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors. | ||||
Official Title ICMJE | "An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors." | ||||
Brief Summary | This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Neoplasms | ||||
Intervention ICMJE | Drug: R1530
Administered po at escalating doses (10 cohorts) |
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Study Arm (s) | Experimental: 1
Intervention: Drug: R1530 |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 48 | ||||
Completion Date | February 2009 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493155 | ||||
Other Study ID Numbers ICMJE | NO18674 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche | ||||
Verification Date | July 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |