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NCT02240238 · ClinicalTrials.gov registry record · Phase 1

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer

A Phase 1 study of Solid Tumors, sponsored by NanoCarrier Co..

Completed
Registry status
Phase 1
Development phase
119
Enrollment target
20
Study locations

NCT02240238 is a Phase 1 study of Solid Tumors that has completed, run by NanoCarrier Co.. The registered enrollment target is 119 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT02240238, a Phase 1 study of Solid Tumors, has completed, sponsored by NanoCarrier Co..

COMPLETED
Registry status
Phase 1
Development phase
119 participants
Enrollment target
20
Study locations

Study Summary

In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary tract, and bladder cancer.

Conditions Studied

Solid Tumors

Interventions

  • DRUG Gemcitabine
  • DRUG NC-6004

Study Locations (20)

Other

  • Complex Oncology Center - Shumen EOOD - Shumen
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - Meldola
  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda - Milan
  • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Krakow
  • Med-Polonia Sp. z o.o. - Poznan
  • Fundeni Clinical Institute - Bucharest
  • Coltea Clinical Hospital - Bucharest
  • Prof Dr I Chiricuta Institute of Oncology - Cluj-Napoca
  • Oncology Center Sfantul Nectarie - Craiova

California

  • California Cancer Associates for Research and Excellence - Encinitas
  • UC San Diego Moores Cancer Center - La Jolla
  • Pacific Hematology Oncology Associates - San Francisco

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • MD Anderson Cancer Center - Houston

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago

Massachusetts

  • Tufts Medical Center - Boston

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Ohio

  • University Hospitals Case Medical Center - Cleveland

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2014-05
Est. Completion 2019-05-06
Phase Phase 1

Sponsor

NanoCarrier Co.

3 total trials

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What the Registry Record Tells You About NCT02240238

The ClinicalTrials.gov registry entry for NCT02240238 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (58% lower). The listed sponsor is NanoCarrier Co., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.

NCT02240238 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Texas.

Frequently Asked Questions

What is clinical trial NCT02240238 about?

NCT02240238 is a clinical study titled "Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer". In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine. In the expansion phase of the study (Part 2), study will evaluate the activity, safe...

What is the current status of trial NCT02240238?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2014-05. Estimated completion is 2019-05-06.

What conditions does trial NCT02240238 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT02240238?

The interventions under investigation include: Gemcitabine (DRUG), NC-6004 (DRUG).

Who is sponsoring clinical trial NCT02240238?

This trial is sponsored by NanoCarrier Co., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02240238 being conducted?

This trial has 20 study locations across California, Illinois, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.