Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC; Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC; Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877253

GPMOC201

Details and patient eligibility

About

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 plus Carboplatin regimen in subjects with advanced ovarian cancer.

Full description

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥ 18 years old.

• Signed informed consent before inclusion.

• Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)

• Subjects who have measurable disease by RECIST after debulking surgery.

• ECOG performance status of 0, 1, or 2.

• Estimated life expectancy of more than 6 months

• Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit

  • Hb ≥ 10g/dl
  • ANC ≥ 1.5×10^9/L
  • Platelet Count ≥ 100×10^9/L
  • Serum total bilirubin ≤ 1.5×ULN
  • Serum AST and ALT ≤ 2.5×ULN
  • Serum ALP ≤ 2.5×ULN
  • Serum creatinine ≤ 1.5×ULN

Exclusion criteria

• Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.

• Subjects who have a history of radiotherapy to pelvis or abdominal cavity

• Subjects who receive immunotherapy or hormonal therapy for ovarian cancer

• Subjects who have other malignancies within the past 5 years

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

• Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)

• Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0

• Subjects who have serious medical condition

  • Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
  • Uncontrollable infection
  • Previous allergic reactions in connection with paclitaxel and carboplatin

• Subjects who participate another clinical trial within the last 4 weeks before inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

Dose Level One

Experimental group

Treatment:

Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC

Dose Level Two

Experimental group

Treatment:

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

Dose Level Three

Experimental group

Treatment:

Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC