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
Sponsor:
Information provided by:
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01276548
First received: January 12, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01276548

Locations
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

No publications provided

ClinicalTrials.gov 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
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014