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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)

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ClinicalTrials.gov Identifier: NCT01276548
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Genexol®-PM plus Carboplatin Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
Active Comparator: Genexol® plus Carboplatin Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 3 years ]
    The period from the date of first administration to the date of the patient's death

  2. 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

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276548


Locations
Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of, 138-736
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01276548     History of Changes
Other Study ID Numbers: GPMOC202
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents