Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Genexol-PM

• Registration Number: NCT00882973
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Primary Completion: 2009-08
• Study Completion: 2010-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Subjects who aged 18 years or older

2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial

3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

4. Subjects with no other malignancy diagnosed within past five years except for:

   • Cured non-melanoma skin cancer
   • Cured cervical intraepithelial neoplasia (CIN)
   • Cured In-situ cervical cancer (CIS)

5. Subjects who are ECOG performance status of ≤ 1

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Genexol-PM	Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
Cohort 1	Genexol-PM	Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
Cohort 3	Genexol-PM	Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2

Primary Outcome Measures

Name	Time	Method
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine	1 year
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine	1 year

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression	1 year
Safety profiles	1 year
Progression free survival	1 year
Objective response rate (complete response (CR) + partial response (PR))	1 year