- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02739633
Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Recruiting
- Samyang Biopharmaceuticals
-
Principal Investigator:
- Hyun Woo Lee, M.D
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR) as assessed by RECIST.
Time Frame: 8 weeks
|
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. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: 2 years
|
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. |
2 years
|
Overall survival (OS)
Time Frame: 2 years
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OS will be summarized using Kaplan-Meier methods.
|
2 years
|
Disease control rate (DCR)
Time Frame: 8 weeks
|
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease
|
8 weeks
|
Number of participants with adverse events
Time Frame: Baseline up to Day 21 after the last dose of study treatment
|
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. |
Baseline up to Day 21 after the last dose of study treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hyun Woo Lee, M.D., Ajou University Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Recurrence
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- Genexol-PM PC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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