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

Ovarian Cancer Clinical Trial

— GPMOC202  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276548
• Other study ID #: GPMOC202
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2011
• Last updated: May 8, 2017
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: May 2017
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC

• Genexol® 175mg/m2 plus Carboplatin 5 AUC

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu, Pungnap-2 Dong

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate	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.	up to 6 cycles
Secondary	Overall Survival	The period from the date of first administration to the date of the patient's death	up to 3 years
Secondary	Progression Free Survival	The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death	up to 3 years
Secondary	Time to Progression	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	up to 3 years