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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 (GPMOC202)

Samyang Biopharmaceuticals Corporation logo

Samyang Biopharmaceuticals Corporation

Status and phase

Completed
Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC
Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC

Study type

Interventional

Funder types

Industry

Identifiers

NCT01276548
GPMOC202

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Genexol®-PM plus Carboplatin
Experimental group
Treatment:
Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
Genexol® plus Carboplatin
Active Comparator group
Treatment:
Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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