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

NCT02739633 | Unknown Phase 2

• 1 other identifier: Genexol-PM PC
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Adenocarcinoma of the Pancreas; Metastatic Adenocarcinoma of the Pancreas

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (4)

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Disease control rate (DCR)

  8 weeks

• Number of participants with adverse events

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

Study Arms (1)

Genexol-PM + Gemcitabine

EXPERIMENTAL

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.

Drug: Genexol-PM; Drug: Gemcitabine

Interventions

Genexol-PM 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.

Also known as: Cremorphor EL-free paclitaxel

Genexol-PM + Gemcitabine

Gemcitabine 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.

Genexol-PM + Gemcitabine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Samyang Biopharmaceuticals

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

genexol-PM; Gemcitabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hyun Woo Lee, M.D.

  Ajou University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)