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NCT00307255 · ClinicalTrials.gov registry record · Phase 1

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors

A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00307255: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT00307255 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00307255, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.

Primary Outcome

Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)

Interventions

  • DRUG paclitaxel albumin-stabilized nanoparticle formulation
  • DRUG gemcitabine hydrochloride

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2006-08
Est. Completion 2008-10
Phase Phase 1

What the finished NCT00307255 record still lists

NCT00307255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which paclitaxel albumin-stabilized nanoparticle formulation is the first listed.

NCT00307255 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00307255 about?

NCT00307255 is a clinical study titled "Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors". RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kil...

What is the current status of trial NCT00307255?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-08. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00307255?

The interventions under investigation include: paclitaxel albumin-stabilized nanoparticle formulation (DRUG), gemcitabine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00307255?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00307255's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT00307255, the US trial registry maintained by the National Library of Medicine. NCT00307255 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.