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

Primary Purpose

Recurrent Adenocarcinoma of the Pancreas, Metastatic Adenocarcinoma of the Pancreas

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Genexol-PM

Gemcitabine

About this trial

This is an interventional treatment trial for Recurrent Adenocarcinoma of the Pancreas focused on measuring Chemotherapy, Gemcitabine, Recurrent and metastatic adenocarcinoma of the pancreas, Genexol-PM, Paclitaxel

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
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.
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
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.
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:

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.
Patients have uncontrolled bacterial, viral, or fungal infections
Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

Sites / Locations

Samyang BiopharmaceuticalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genexol-PM + Gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR) as assessed by RECIST.

ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later.

Secondary Outcome Measures

Progression free survival (PFS)

Time from the date of enrollment until the date of objective disease progression or the date of death. PFS will be summarized using Kaplan-Meier methods.

Overall survival (OS)

OS will be summarized using Kaplan-Meier methods.

Disease control rate (DCR)

DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease

Number of participants with adverse events

A adverse event (AE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 21 days after the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.

Full Information

NCT ID

NCT02739633

First Posted

March 21, 2016

Last Updated

April 16, 2018

Sponsor

Samyang Biopharmaceuticals Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02739633

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samyang Biopharmaceuticals Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Adenocarcinoma of the Pancreas, Metastatic Adenocarcinoma of the Pancreas

Keywords

Chemotherapy, Gemcitabine, Recurrent and metastatic adenocarcinoma of the pancreas, Genexol-PM, Paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Genexol-PM + Gemcitabine

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Genexol-PM

Other Intervention Name(s)

Cremorphor EL-free paclitaxel

Intervention Description

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

Intervention Name(s)

Gemcitabine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective response rate (ORR) as assessed by RECIST.

Description

ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Time from the date of enrollment until the date of objective disease progression or the date of death. PFS will be summarized using Kaplan-Meier methods.

Time Frame

2 years

Title

Overall survival (OS)

Description

OS will be summarized using Kaplan-Meier methods.

Time Frame

2 years

Title

Disease control rate (DCR)

Description

DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease

Time Frame

8 weeks

Title

Number of participants with adverse events

Description

Time Frame

Baseline up to Day 21 after the last dose of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media). Male or non-pregnant and non-lactating female, and ≥ 20 years of age. 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. 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 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. 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: 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. Patients have uncontrolled bacterial, viral, or fungal infections Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Woo Lee, M.D.

Organizational Affiliation

Ajou University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samyang Biopharmaceuticals

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miryung Jin

Phone

+82-2-740-7289

miryung.jin@samyang.com

First Name & Middle Initial & Last Name & Degree

Hyun Woo Lee, M.D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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