Clinical trial · Interventional
Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
NCT00877253CI-TRIAL-00007165completedPhase 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)
The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genexol-PM 220mg/㎡, Carboplatin 5AUC | Drug | — | UNRESOLVED |
| Genexol-PM 260mg/㎡, Carboplatin 5AUC | Drug | — | UNRESOLVED |
| Genexol-PM 300mg/㎡, Carboplatin 5AUC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level One
- interventionNames
- Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
- type
- EXPERIMENTAL
- label
- Dose Level Two
- interventionNames
- Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
- type
- EXPERIMENTAL
- label
- Dose Level Three
- interventionNames
- Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥ 18 years old. * Signed informed consent before inclusion. * Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV) * Subjects who have measurable disease by RECIST after debulking surgery. * ECOG performance status of 0, 1, or 2. * Estimated life expectancy of more than 6 months * Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit * Hb ≥ 10g/dl * ANC ≥ 1.5×10\^9/L * Platelet Count ≥ 100×10\^9/L * Serum total bilirubin ≤ 1.5×ULN * Serum AST and ALT ≤ 2.5×ULN * Serum ALP ≤ 2.5×ULN * Serum creatinine ≤ 1.5×ULN Exclusion Criteria: * Subjects who have received chemotherapy for ovarian cancer other than debulking surgery. * Subjects who have a history of radiotherapy to pelvis or abdominal cavity * Subjects who receive immunotherapy or hormonal therapy for ovarian cancer * Subjects who have other malignancies within the past 5 years * Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit * Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS) * Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0 * Subjects who have serious medical condition * Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure) * Uncontrollable infection * Previous allergic reactions in connection with paclitaxel and carboplatin * Subjects who participate another clinical trial within the last 4 weeks before inclusion
References
Publications (0)
Data not yet available
No reference posted for this study.