Trial to Determine the Maximum Tolerated Dose of Genexol®-PM Plus Carboplatin and Evaluate the Efficacy and Safety of Genexol®-PM Regimens in Subjects With Advanced Ovarian Cancer

This study is ongoing, but not recruiting participants.

First Received: April 3, 2009 Last Updated: April 6, 2009 History of Changes

Sponsored by:	Samyang
Information provided by:	Samyang
ClinicalTrials.gov Identifier:	NCT00877253

Purpose

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 regimens in subjects with advanced ovarian cancer.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Genexol®-PM plus Carboplatin	Phase I Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Study Type:

Interventional

Further study details as provided by Samyang:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective Response Rate (Complete Response (CR) + Partial Response (PR)) [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: about 1 year (until end of trial) ] [ Designated as safety issue: Yes ]
Safety profiles [ Time Frame: about 1 year (till end of trial) ] [ Designated as safety issue: Yes ]

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 advanced Ovarian Cancer.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	GPMOC201
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00877253 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases

Urogenital Neoplasms
Carboplatin
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Gonadal Disorders
Antineoplastic Agents
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Carboplatin

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009