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

NCT ID: NCT01276548

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-09-30

Brief 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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genexol®-PM plus Carboplatin

Group Type: EXPERIMENTAL

Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC

Intervention Type: DRUG

Genexol® plus Carboplatin

Group Type: ACTIVE_COMPARATOR

Genexol® 175mg/m2 plus Carboplatin 5 AUC

Intervention Type: DRUG

Interventions

Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC

Intervention Type: DRUG

Genexol® 175mg/m2 plus Carboplatin 5 AUC

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, Songpa-gu, Pungnap-2 Dong, South Korea

Countries

South Korea

Other Identifiers

GPMOC202

Identifier Type: -

Identifier Source: org_study_id