Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer

NCT02739529 | Unknown Phase 1

• 1 other identifier: GPMOC101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD)

  MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT

  2 years

• The recommended dose for the phase II study

  Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups

  2 years

Secondary Outcomes (2)

• The dose limiting toxicity (DLT)

  2 years

• Toxicities

  2 years

Study Arms (3)

Cohort 1

EXPERIMENTAL

Genexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1

Drug: Genexol-PM

Cohort 2

EXPERIMENTAL

Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1

Drug: Genexol-PM

Cohort 3

EXPERIMENTAL

Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1

Drug: Genexol-PM

Interventions

Genexol-PM DRUG

Cremophor EL-free polymeric micelle of paclitaxel

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who aged 20 years or older and under 80 year old female
• Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
• Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
• Patients whose ECOG performance score are 0-2
• Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs
• Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more.
• ANC ≥ 1500/mm3
• Platelet Count ≥ 100,000/mm3
• Serum AST and ALT ≤ 2.5 X ULN
• Serum ALP ≤ 2.5 X ULN
• Serum creatinine ≤ 2.5 X ULN
• Patients who participated voluntarily and who provided written informed consent before participating in the study

You may not qualify if:

• Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
• Patients who received radiotherapy at abdominal cavity or pelvis
• Patients who were receiving immunotherapy or hormone therapy
• Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
• Patients with a past or present medical history of metastasis in central nervous system (CNS)
• Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy
• Patients with severe comorbidities as follows
• medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision
• severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2\~4 congestive heart failure defined by New York Heart Association criteria)
• uncontrolled active infectious disease
• hypersensitivity to the test drugs or the vehicle
• Patients who participated in another study within 4 weeks before the screening
• Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Samyang Biopharmaceuticals

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

genexol-PM

Study Officials

• Yong Man Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)