Clinical trial NCT02739633: Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Official title: Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Adenocarcinoma of the Pancreas
Metastatic Adenocarcinoma of the Pancreas
Keywords: Chemotherapy
Gemcitabine
Recurrent and metastatic adenocarcinoma of the pancreas
Genexol-PM
Paclitaxel
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.

Detailed description: The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.

Eligibility 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).

Primary outcomes:
measure: Objective response rate (ORR) as assessed by RECIST.
timeFrame: 8 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Disease control rate (DCR)
timeFrame: 8 weeks
measure: Number of participants with adverse events
timeFrame: Baseline up to Day 21 after the last dose of study treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samyang Biopharmaceuticals
Study officials:
affiliation: Ajou University Medical Center
name: Hyun Woo Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: