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

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC; Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC

• Registration Number: NCT01276548
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2012-05
• Study Completion: 2012-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genexol®-PM plus Carboplatin	Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC	-
Genexol® plus Carboplatin	Genexol® 175mg/m2 plus Carboplatin 5 AUC	-

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate	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

Name	Time	Method
Overall Survival	up to 3 years	The period from the date of first administration to the date of the patient's death
Progression Free Survival	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	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of