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NCT01204476 · ClinicalTrials.gov registry record · Phase 1

Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

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

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT01204476: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01204476 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01204476, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better treatment for neuroendocrine cancer.

Primary Outcome

Analysis will be performed using a patient summary of the number of cycles of study drug administered by initial dose level, and will be presented including a flag for DLTs which occurred during course 1. The recommended Phase II dose will also be presented.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Everolimus
  • DRUG Octreotide Acetate
  • OTHER Pharmacological Study
  • BIOLOGICAL Cixutumumab

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-10
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01204476 record still lists

NCT01204476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01204476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01204476 about?

NCT01204476 is a clinical study titled "Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma". This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tum...

What is the current status of trial NCT01204476?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-10.

What interventions are being tested in trial NCT01204476?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Everolimus (DRUG), Octreotide Acetate (DRUG), Pharmacological Study (OTHER), Cixutumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01204476?

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 NCT01204476's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 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 NCT01204476, the US trial registry maintained by the National Library of Medicine. NCT01204476 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.