A Trial 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
Conditions
Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Genexol®-PM plus Carboplatin
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Subjects who aged 18 years or older

2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial

3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

Exclusion Criteria:

1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.

2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.

3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
Location
Asan Medical Center
Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of
Status: Recruiting
Contact: Eun Ja Kim - 82-2-3010-3629
Sponsors
Samyang Biopharmaceuticals Corporation
Source
Samyang Biopharmaceuticals Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page