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NCT01298401 · ClinicalTrials.gov registry record · Phase 1

Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

A Phase 1 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT01298401 is a Phase 1 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 8 participants.

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The verdict

NCT01298401, a Phase 1 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab, capecitabine, and maintenance therapy in treating patients with locally advanced cancer of the pancreas.

Interventions

  • DRUG capecitabine
  • RADIATION 3-dimensional conformal radiation therapy
  • DRUG gemcitabine hydrochloride
  • BIOLOGICAL ganitumab

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2012-02
Est. Completion 2013-11
Phase Phase 1

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT01298401

The ClinicalTrials.gov registry entry for NCT01298401 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which capecitabine is the first listed.

NCT01298401 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01298401 about?

NCT01298401 is a clinical study titled "Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas". RATIONALE: Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochlorid...

What is the current status of trial NCT01298401?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-02. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01298401?

The interventions under investigation include: capecitabine (DRUG), 3-dimensional conformal radiation therapy (RADIATION), gemcitabine hydrochloride (DRUG), ganitumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01298401?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.