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

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