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NCT00996515 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

A Phase 1 study, sponsored by New Mexico Cancer Research Alliance.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00996515: Completed Phase 1 study, sponsored by New Mexico Cancer Research Alliance.

NCT00996515 is a Phase 1 study that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00996515, a Phase 1 study, has completed, sponsored by New Mexico Cancer Research Alliance.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

PRIMARY OBJECTIVES: I. To document the toxicities, and reversibility of toxicities, of this regimen of 5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.

Interventions

  • DRUG 5-azacytidine, erlotinib
  • DRUG Erlotinib PO and Vidaza IV

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2008-06
Est. Completion 2011-09
Phase Phase 1

What the finished NCT00996515 record still lists

NCT00996515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which 5-azacytidine, erlotinib is the first listed.

NCT00996515 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00996515 about?

NCT00996515 is a clinical study titled "A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies". PRIMARY OBJECTIVES: I. To document the toxicities, and reversibility of toxicities, of this regimen of 5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To determine any potential anti-tumor effects, as determined by the objective tumor response (comple...

What is the current status of trial NCT00996515?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-06. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00996515?

The interventions under investigation include: 5-azacytidine, erlotinib (DRUG), Erlotinib PO and Vidaza IV (DRUG).

Who is sponsoring clinical trial NCT00996515?

This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00996515's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT00996515, the US trial registry maintained by the National Library of Medicine. NCT00996515 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.