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NCT01392521 · ClinicalTrials.gov registry record · Phase 1

Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer

A Phase 1 study of Neoplasms, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target
8
Study locations

NCT01392521 is a Phase 1 study of Neoplasms that has completed, run by Bayer. The registered enrollment target is 64 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT01392521, a Phase 1 study of Neoplasms, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target
8
Study locations

Study Summary

The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions: 1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels? 2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies? 3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect? 4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect? 5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?

Conditions Studied

Neoplasms

Interventions

  • DRUG Copanlisib + Refametinib (BAY86-9766)

Study Locations (8)

Texas

  • - Houston
  • - Tyler

Arizona

  • - Scottsdale

Nevada

  • - Las Vegas

South Carolina

  • - Greenville

Washington

  • - Vancouver

Baden-Wurttemberg

  • - Freiburg im Breisgau

Other

  • - Rotterdam

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2011-07
Est. Completion 2014-04
Phase Phase 1

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01392521

The ClinicalTrials.gov registry entry for NCT01392521 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Copanlisib + Refametinib (BAY86-9766) is the first listed.

NCT01392521 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Texas, Arizona, Nevada.

Frequently Asked Questions

What is clinical trial NCT01392521 about?

NCT01392521 is a clinical study titled "Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer". The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following...

What is the current status of trial NCT01392521?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2011-07. Estimated completion is 2014-04.

What conditions does trial NCT01392521 study?

This clinical trial studies the following conditions: Neoplasms.

What interventions are being tested in trial NCT01392521?

The interventions under investigation include: Copanlisib + Refametinib (BAY86-9766) (DRUG).

Who is sponsoring clinical trial NCT01392521?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01392521 being conducted?

This trial has 8 study locations across Arizona, Nevada, South Carolina, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.