Clinical trial · Interventional
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer
NCT01463982CI-TRIAL-00017624completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oratecan and Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oratecan and Capecitabine
- description
- Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine * Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5 * HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5 * Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14
- interventionNames
- Drug: Oratecan and Capecitabine
Primary outcomes (1)
- measure
- Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
- timeFrame
- Cycle 1 (21 days)
- description
- If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.