Clinical trial · Interventional
Clinical Study of Decitabine and Paclitaxel Combination Therapy
An Open-labelled, Parallel, Multiple Ascending Dose, Phase Ib Clinical Study of Decitabine and Paclitaxel Combination Therapy in Treating Patients With Metastatic and Locally Advanced Breast Cancer
NCT03282825CI-TRIAL-00031300unknownPhase 1ClinicalTrials.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)
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
Conditions
Conditions (1)
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 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine
- description
- A standard 3+3 trial design will be used for Decitabine dose escalation cohorts. The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel. Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2
- interventionNames
- Drug: Decitabine
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
- timeFrame
- for about 4 weeks
- description
- According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 19 years as female 2. be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy 3. according to RECIST ver.1.1, one or more evaluable lesion 4. Eastern cooperative oncology group(ECOG) performance score is o or 1 5. lesion for core biopsy 6. Within 28days of planned first study treatment day, laboratory safety test is satisfied. ANC ≥1500cells/microliter, Platelet count ≥ 100,000 cells/microliter, Hemoglobin≥8.5g/dl, ALT and AST ≤ 2ULN, ALP≤2.5ULN, Serum total bilirubin≤1.25 ULN, PT-INR and aPTT≤1.5ULN, Creatinine≥50ml/min 7. menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study 8. Given signed and dated written informed consent form Exclusion Criteria: 1. Symptomatic metastasis and Leptomeningeal metastasis 2. Injection of paclitaxel for metastatic breast cancer within 6 months 3. HER2, Positive Breast adenocarcinoma 4. cancertherapy for whole body within 3 weeks 5. radiotherapy for metastatic region within 4 weeks 6. major surgery, open biopsy and trauma within 4 weeks 7. less than 4 weeks post major surgery 8. treatment with consistently systemic corticosteroid or immunosuppressive drug 9. more than 2 grade for peripheral neuropathy 10. Congenital ling QT syndrome or QTc interval \> 480 milisecond 11. occur myocardial infartion within 6 months 12. unstable angina pectoris 13. HIV(+) or AIDS 14. HBsAg(+) or HCV(+) 15. treatment bisphosphonate for hypercalcemia 16. except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years 17. hypersensitivity reaction with paclitaxel or Cremophor EL formulation 18. Pregnant or breast feeding 19. be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee
References
Publications (0)
Data not yet available
No reference posted for this study.