Satraplatin and Vinorelbine in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01220284|
Recruitment Status : Unknown
Verified September 2010 by Southern Europe New Drug Organization.
Recruitment status was: Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: Satraplatin in combo with vinorelbine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||February 2011|
Experimental: Satraplatin in combo with vinorelbine
Escalating doses of satraplatin and oral vinorelbine in subsequent cohorts of 3-6 patients according to the type and severity grade of acute toxicities observed during cycle 1.
The dose escalation process will be discontinued once the MTD is achieved.
Drug: Satraplatin in combo with vinorelbine
- Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs) [ Time Frame: 28 days ]The Maximum Tolerated Dose (MTD) is defined as the dose at which 2 out of 3 to 6 patients experience a DLT.
- Safety [ Time Frame: whole study period ]Safety assessments include routine physical examinations and laboratory evaluations (blood cell counts, functional parameters and chemistry). Adverse events will be graded according to the NCI-CTCAE, Common Terminology Criteria for Adverse Events v.3.0.
- Tumor response [ Time Frame: every 2 months ]Tumor response in target and non-target lesions will be assessed according to the RECIST criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220284
|Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni|
|Bellinzona, Switzerland, 6500|
|Chur, Switzerland, 7000|
|Study Chair:||Cristiana Sessa, MD||Swiss Group for Clinical Cancer Research|