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NCT01198821 · ClinicalTrials.gov registry record · Phase 1

Gem-TABS in Unresectable Pancreatic Carcinoma

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT01198821: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT01198821 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01198821, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

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.

Interventions

  • DRUG Gemcitabine (mg/m²)
  • DRUG Sodium bicarbonate (g/kg/day)

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2010-08
Est. Completion 2011-06
Phase Phase 1

What the finished NCT01198821 record still lists

NCT01198821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Gemcitabine (mg/m²) is the first listed.

NCT01198821 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01198821 about?

NCT01198821 is a clinical study titled "Gem-TABS in Unresectable Pancreatic Carcinoma". 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.

What is the current status of trial NCT01198821?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2010-08. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01198821?

The interventions under investigation include: Gemcitabine (mg/m²) (DRUG), Sodium bicarbonate (g/kg/day) (DRUG).

Who is sponsoring clinical trial NCT01198821?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01198821's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01198821, the US trial registry maintained by the National Library of Medicine. NCT01198821 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.