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NCT00385853 · ClinicalTrials.gov registry record · Phase 1

PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT00385853: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT00385853 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00385853, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy. With this study, we would like to examine the effects of PTK when used in combination with radiation therapy and the anti-cancer drug temozolomide, the standard treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the study drug is absorbed, distributed, and cleared from the body.

Interventions

  • DRUG Temozolomide
  • PROCEDURE Radiation Therapy
  • DRUG PTK787/ZK 222584

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2006-09
Est. Completion 2011-09
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT00385853 record still lists

NCT00385853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.

NCT00385853 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00385853 about?

NCT00385853 is a clinical study titled "PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs". PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy. With this st...

What is the current status of trial NCT00385853?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2006-09. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00385853?

The interventions under investigation include: Temozolomide (DRUG), Radiation Therapy (PROCEDURE), PTK787/ZK 222584 (DRUG).

Who is sponsoring clinical trial NCT00385853?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00385853's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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 NCT00385853, the US trial registry maintained by the National Library of Medicine. NCT00385853 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.