Phase 1
Completed N=21
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Source: ClinicalTrials.gov NCT01463982 ↗Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Apr 2015
Primary outcomePrimary: Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination — 0.0; 0.0; 50.0; 0.0 percentage of participants
Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination |
0.0; 0.0; 50.0; 0.0 | — |
| SECONDARY Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) |
0.0; 0.0; 0.0; 33.3; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed advanced solid tumor
- Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
- Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
- Aged ≥19
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
- A life expectancy greater than 12 weeks
- Adequate bone marrow, renal and liver function.
- Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures
Exclusion Criteria
- Patients with hematopoietic malignancies, uncontrolled infection, CNS metastasis.
- Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
- Patients who have GI malabsorption or difficulty taking oral medication
- Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
- Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
Data sourced from ClinicalTrials.gov (NCT01463982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.