Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Phase 1
Completed
NCT01463982
| Condition | Solid Tumor, Advanced Cancer |
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| Phase | Phase 1 |
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| Sponsor | Hanmi Pharmaceutical Company Limited |
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| Status | Completed |
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| Enrollment | 21 participants |
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| Interventions | Oratecan and Capecitabine |
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| Start date | Dec, 2010 |
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| Completion date | Apr, 2012 |
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| Results posted | Apr 23, 2015 |
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Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
Cycle 1 (21 days) · percentage of participants
| Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | 0.0 percentage of participants |
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| Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ | 0.0 percentage of participants |
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| Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | 50.0 percentage of participants |
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| Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | 0.0 percentage of participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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