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
NCT ID: NCT00882973
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-09-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Cohort 1
Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Cohort 2
Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Cohort 3
Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Interventions
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Genexol-PM
Cremophor EL-free polymeric micelle of paclitaxel
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Samyang Biopharmaceuticals Corporation
INDUSTRY
Responsible Party
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Other Identifiers
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GPMPC202
Identifier Type: -
Identifier Source: org_study_id
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