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

NCT ID: NCT02739633

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Recurrent Adenocarcinoma of the Pancreas; Metastatic Adenocarcinoma of the Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genexol-PM + Gemcitabine

Genexol-PM125 mg/m2 will be administered in combination with gemcitabine 1,000 mg/m2 weekly for 3 weeks followed by one week of rest. Each cycle is 28 days.

Group Type: EXPERIMENTAL

Genexol-PM

Intervention Type: DRUG

125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

Gemcitabine

Intervention Type: DRUG

1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

Interventions

Genexol-PM

125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

Intervention Type: DRUG

Gemcitabine

1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

Intervention Type: DRUG

Other Intervention Names

Cremorphor EL-free paclitaxel

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun Woo Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University Medical Center

Locations

Samyang Biopharmaceuticals

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Miryung Jin

Role: primary

miryung.jin@samyang.com

+82-2-740-7289

Other Identifiers

Genexol-PM PC

Identifier Type: -

Identifier Source: org_study_id