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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
  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 260mg/m2 plus Carboplatin 5 AUC Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 102
Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  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
Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of, 138-736
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01276548     History of Changes
Other Study ID Numbers: GPMOC202
Study First Received: January 12, 2011
Last Updated: May 8, 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

ClinicalTrials.gov processed this record on July 25, 2017