Status:
COMPLETED
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
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- 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.
- 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)
- Subjects who are ECOG performance status of ≤ 1
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00882973
Start Date
September 1 2008
End Date
November 1 2010
Last Update
May 5 2017
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