Overview

Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Treatments:
Gemcitabine
Paclitaxel
Pancreatin
Pancrelipase
Criteria
Inclusion Criteria:

1. Patient has definitive histologically or cytologically confirmed recurrent and
metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and
metastatic pancreatic adenocarcinoma will be made by integrating the histopathological
data within the context of the clinical and radiographic data. Patients with islet
cell neoplasms are excluded.

2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks
prior to randomization in the study.

3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic
to CT contrast media).

4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age.

5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to
randomization):

- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L

- Platelet count ≥ 100,000/mm3 (100 × 10^9/L)

- Hemoglobin (Hgb) ≥ 9 g/dL.

6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior
to randomization):

- AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver
metastases are clearly present, then ≤ 5 × ULN is allowed.

- Total bilirubin ≤ULN

7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required
to assess KPS. If discrepant, the one with the lowest assessment will be considered
true.

8. Patient has voluntarily agreed to participate in the study, and signed the Informed
Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria:

1. History of malignancy in the last 5 years. Patients with prior history of in situ
cancer or basal or squamous cell skin cancer are eligible. Patients with other
malignancies are eligible if they were cured by surgery alone or surgery plus
radiotherapy and have been continuously disease-free for at least 5 years.

2. Patients have uncontrolled bacterial, viral, or fungal infections

3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis
C.

4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel,
Gemcitabine, or Cremophor EL.

5. Patients with high cardiovascular risk, including recent coronary stenting or
myocardial infarction in the past 6 months.

6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).