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NCT01217450 · ClinicalTrials.gov registry record · Phase 1

Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT01217450: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01217450 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01217450, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244 when given together with cetuximab in patients with advanced or refractory solid tumors that cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, 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 tumor-killing substances to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.

Primary Outcome

Graded using the NCI Common Toxicity Criteria.

Interventions

  • OTHER laboratory biomarker analysis
  • BIOLOGICAL cetuximab
  • OTHER pharmacological study
  • DRUG selumetinib

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2012-10
Est. Completion 2014-05
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01217450 record still lists

NCT01217450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

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

NCT01217450 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01217450 about?

NCT01217450 is a clinical study titled "Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors". This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244 when given together with cetuximab in patients with advanced or refractory solid tumors that cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzym...

What is the current status of trial NCT01217450?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-10. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01217450?

The interventions under investigation include: laboratory biomarker analysis (OTHER), cetuximab (BIOLOGICAL), pharmacological study (OTHER), selumetinib (DRUG).

Who is sponsoring clinical trial NCT01217450?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01217450's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 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 NCT01217450, the US trial registry maintained by the National Library of Medicine. NCT01217450 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.