Pancreatic Cancer
Conditions
Brief summary
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 gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
Interventions
DRUGGenexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 4. Subjects with no other malignancy diagnosed within past five years except for: * Cured non-melanoma skin cancer * Cured cervical intraepithelial neoplasia (CIN) * Cured In-situ cervical cancer (CIS) 5. Subjects who are ECOG performance status of ≤ 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine | 1 year |
| The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (complete response (CR) + partial response (PR)) | 1 year |
| Time to tumor progression | 1 year |
| Progression free survival | 1 year |
| Safety profiles | 1 year |
Outcome results
None listed