Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Adenocarcinoma

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

genexol-PM

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

Genexol-PM

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.

Miryung Jin

Hyun Woo Lee, M.D

Hyun Woo Lee, M.D.

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

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.

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

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 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.

OS will be summarized using Kaplan-Meier methods.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas	NCT02739633	Recurrent Adeno... Metastatic Aden...	Genexol-PM Gemcitabine	20 Years -	Samyang Biopharmaceuticals Corporation
Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas	NCT02739633	Recurrent Adeno... Metastatic Aden...	Genexol-PM Gemcitabine	20 Years -	Samyang Biopharmaceuticals Corporation

Spots Global Cancer Trial Database for recurrent and metastatic adenocarcinoma of the pancreas