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Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00877253
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE April 3, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date June 12, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. [ Time Frame: until either MTD is achieved or maximum planned dose is tested ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and carboplatin. [ Time Frame: until either MTD is achieved or maximum planned dose is tested ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
  • Objective Response Rate (Complete Response (CR) + Partial Response (PR)) [ Time Frame: about 1 year (until end of trial) ]
  • Time to Tumor Progression [ Time Frame: about 1 year (until end of trial) ]
  • Overall Survival [ Time Frame: about 1 year (until end of trial) ]
  • Safety profiles [ Time Frame: about 1 year (till end of trial) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer
Official Title  ICMJE Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
Brief Summary The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.
Detailed Description This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
    Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
  • Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
    Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
  • Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC
    Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.
Study Arms  ICMJE
  • Experimental: Dose Level One
    Intervention: Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
  • Experimental: Dose Level Two
    Intervention: Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
  • Experimental: Dose Level Three
    Intervention: Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2012)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women ≥ 18 years old.
  • Signed informed consent before inclusion.
  • Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
  • Subjects who have measurable disease by RECIST after debulking surgery.
  • ECOG performance status of 0, 1, or 2.
  • Estimated life expectancy of more than 6 months
  • Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit

    • Hb ≥ 10g/dl
    • ANC ≥ 1.5×10^9/L
    • Platelet Count ≥ 100×10^9/L
    • Serum total bilirubin ≤ 1.5×ULN
    • Serum AST and ALT ≤ 2.5×ULN
    • Serum ALP ≤ 2.5×ULN
    • Serum creatinine ≤ 1.5×ULN

Exclusion Criteria:

  • Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
  • Subjects who have a history of radiotherapy to pelvis or abdominal cavity
  • Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
  • Subjects who have other malignancies within the past 5 years
  • Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
  • Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
  • Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
  • Subjects who have serious medical condition

    • Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
    • Uncontrollable infection
    • Previous allergic reactions in connection with paclitaxel and carboplatin
  • Subjects who participate another clinical trial within the last 4 weeks before inclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877253
Other Study ID Numbers  ICMJE GPMOC201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samyang Biopharmaceuticals Corporation
Study Sponsor  ICMJE Samyang Biopharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soon Beom Kang, MD, PhD Seoul National University Hospital
Principal Investigator: Yong Man Kim, MD, PhD Asan Medical Center
Principal Investigator: Byoung Gie Kim, MD, PhD Samsung Medical Center
Principal Investigator: Young Tae Kim, MD, PhD Yonsei University Health System Severance Hospital
PRS Account Samyang Biopharmaceuticals Corporation
Verification Date June 2012

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