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The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genexol®-PM plus Carboplatin | Experimental |
| |
| Genexol® plus Carboplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC | Drug |
| ||
| Genexol® 175mg/m2 plus Carboplatin 5 AUC |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate | Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse. | up to 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The period from the date of first administration to the date of the patient's death | up to 3 years |
| Progression Free Survival | The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu, Pungnap-2 Dong | 138-736 | South Korea |
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| Drug |
|
| up to 3 years |
| Time to Progression | The period from the date of first administration to the date of tumor progression by CA125 and RECIST or objective tumor progression, excluding progression-free death | up to 3 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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