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Gem-TABS in Unresectable Pancreatic Carcinoma

NCT01198821 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-02-23

No results posted yet for this study

Summary

The purpose of this study is to:

Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.

Determine if the combination of sodium bicarbonate and gemcitabine produces better control of pancreatic cancer than gemcitabine alone.

Conditions

Interventions

DRUG

Sodium bicarbonate (g/kg/day)

Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0

DRUG

Gemcitabine (mg/m²)

Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000

Sponsors & Collaborators

  • Reliable Cancer Therapies

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Gregory Springett, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198821 on ClinicalTrials.gov