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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Samyang Biopharmaceuticals Corporation.
Recruitment status was  Recruiting
Information provided by:
Samyang Biopharmaceuticals Corporation Identifier:
First received: January 12, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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.

Condition Intervention Phase
Ovarian Cancer
Drug: Genexol®-PM plus Carboplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Samyang Biopharmaceuticals Corporation:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01276548

Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of, 138-736
Contact: Eun Ja Kim    82-2-3010-3629      
Principal Investigator: Yong-Man Kim, M.D. Ph.D.         
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
  More Information Identifier: NCT01276548     History of Changes
Other Study ID Numbers: GPMOC202 
Study First Received: January 12, 2011
Last Updated: January 12, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents processed this record on October 21, 2016