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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 (GPMOC202)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01276548
First received: January 12, 2011
Last updated: May 8, 2017
Last verified: May 2017
January 12, 2011
May 8, 2017
October 2009
May 2012   (Final data collection date for primary outcome measure)
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate [ Time Frame: up to 6 cycles ]
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.
Not Provided
Complete list of historical versions of study NCT01276548 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: up to 3 years ]
    The period from the date of first administration to the date of the patient's death
  • Progression Free Survival [ Time Frame: up to 3 years ]
    The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death
  • Time to Progression [ Time Frame: up to 3 years ]
    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
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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
Not Provided
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
  • Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC
  • Experimental: Genexol®-PM plus Carboplatin
    Intervention: Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
  • Active Comparator: Genexol® plus Carboplatin
    Intervention: Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
September 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01276548
GPMOC202
Yes
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Samyang Biopharmaceuticals Corporation
Samyang Biopharmaceuticals Corporation
Not Provided
Not Provided
Samyang Biopharmaceuticals Corporation
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP