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NCT03213002 · ClinicalTrials.gov registry record · Phase 1

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

A Phase 1 study of Cancer and Glioblastoma, sponsored by Northwell Health.

Recruiting
Registry status
Phase 1
Development phase
67
Enrollment target
1
Study location

NCT03213002 is a Phase 1 study of Cancer and Glioblastoma that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 67 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03213002, a Phase 1 study of Cancer and Glioblastoma, is actively recruiting participants, sponsored by Northwell Health.

RECRUITING
Registry status
Phase 1
Development phase
67 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Interventions

  • DRUG Capecitabine
  • DRUG Temozolomide

Study Locations (1)

New York

  • Lenox Hill Brain Tumor Center - New York

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2017-06-13
Est. Completion 2027-06
Phase Phase 1

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT03213002

The ClinicalTrials.gov registry entry for NCT03213002 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.

NCT03213002 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03213002 about?

NCT03213002 is a clinical study titled "Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM". The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherap...

What is the current status of trial NCT03213002?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2017-06-13. Estimated completion is 2027-06.

What conditions does trial NCT03213002 study?

This clinical trial studies the following conditions: Cancer, Glioblastoma, Brain Tumor, Brain Cancer, Brain Tumor Adult.

What interventions are being tested in trial NCT03213002?

The interventions under investigation include: Capecitabine (DRUG), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT03213002?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03213002 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.