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NCT02188264 · ClinicalTrials.gov registry record · Phase 1

Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer

A Phase 1 study of Solid Neoplasm and Stage IVA Colorectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
10
Study locations

NCT02188264: Completed Phase 1 study of Solid Neoplasm and Stage IVA Colorectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

NCT02188264 is a Phase 1 study of Solid Neoplasm and Stage IVA Colorectal Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 940-participant average among 12 other Solid Neoplasm trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02188264, a Phase 1 study of Solid Neoplasm and Stage IVA Colorectal Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
10
Study locations

Study Summary

This phase I/Ib trial studies the side effects and best dose of selumetinib when given together with cyclosporine in treating patients with solid tumors or colorectal cancer that have spread to other places in the body and cannot be cured or controlled with treatment. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as cyclosporine, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving selumetinib and cyclosporine may be a better treatment for solid tumors or colorectal cancer.

Primary Outcome

The maximum tolerated dose will be defined as the highest dose in which 0 or 1 out of 6 patients have a DLT.

Conditions Studied

Solid Neoplasm Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Recurrent Colorectal Carcinoma Stage IIIA Colorectal Cancer AJCC v7 Stage IIIB Colorectal Cancer AJCC v7 Stage IIIC Colorectal Cancer AJCC v7

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Cyclosporine
  • DRUG Selumetinib
  • OTHER Pharmacological Study

Study Locations (10)

Missouri

  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis

California

  • University of California Davis Comprehensive Cancer Center - Sacramento

Colorado

  • UCHealth University of Colorado Hospital - Aurora

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

North Carolina

  • UNC Lineberger Comprehensive Cancer Center - Chapel Hill

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Pennsylvania

  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-08-29
Est. Completion 2019-04-26
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT02188264 record still lists

NCT02188264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 940-participant average among 12 other Solid Neoplasm trials with a reported enrollment target (96% lower).

The record links to 7 conditions, with Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02188264 lists 10 locations in 9 states (Missouri, California, Colorado).

Frequently Asked Questions

What is clinical trial NCT02188264 about?

NCT02188264 is a clinical study titled "Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer". This phase I/Ib trial studies the side effects and best dose of selumetinib when given together with cyclosporine in treating patients with solid tumors or colorectal cancer that have spread to other places in the body and cannot be cured or controlled with treatment. Selumetinib may stop the growth...

What is the current status of trial NCT02188264?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-08-29. Estimated completion is 2019-04-26.

What conditions does trial NCT02188264 study?

This clinical trial studies the following conditions: Solid Neoplasm, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Recurrent Colorectal Carcinoma, Stage IIIA Colorectal Cancer AJCC v7.

What interventions are being tested in trial NCT02188264?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cyclosporine (DRUG), Selumetinib (DRUG), Pharmacological Study (OTHER).

Who is sponsoring clinical trial NCT02188264?

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

Where is trial NCT02188264 being conducted?

This trial has 10 study locations across California, Colorado, Missouri, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02188264's enrollment target sits among peer trials

40 8th of 12 higher than 5 of 12 other Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Neoplasm 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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Related registry views

Source: ClinicalTrials.gov NCT02188264, the US trial registry maintained by the National Library of Medicine. NCT02188264 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.