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

NCT01276548 | Completed Phase 2 DMC

• 1 other identifier: GPMOC202
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival

  up to 3 years

• Progression Free Survival

  up to 3 years

• Time to Progression

  up to 3 years

Study Arms (2)

Genexol®-PM plus Carboplatin

EXPERIMENTAL

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

Genexol® plus Carboplatin

ACTIVE COMPARATOR

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

Interventions

Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC DRUG

Genexol®-PM plus Carboplatin

Genexol® 175mg/m2 plus Carboplatin 5 AUC DRUG

Genexol® plus Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who aged 18 years or older
• Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
• 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.

You may not qualify if:

• 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.
• 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.
• Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, Pungnap-2 Dong, 138-736, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: October 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

KR (1)