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NCT00882973 Clinical Trial

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

Pancreatic Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00882973
Other study ID # GPMPC202
Secondary ID
Status Completed
Phase Phase 1
First received April 16, 2009
Last updated May 2, 2017
Start date September 2008
Est. completion date November 2010

Study information
Verified date May 2017
Source Samyang Biopharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date November 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Samyang Biopharmaceuticals Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine 1 year
Primary The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine 1 year
Secondary Objective response rate (complete response (CR) + partial response (PR)) 1 year
Secondary Time to tumor progression 1 year
Secondary Progression free survival 1 year
Secondary Safety profiles 1 year
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