NCT02656849

BAY 1000394 for MCL-1-, MYC-, and CCNE1-Amplified Tumors

A Phase II Study of BAY 1000394 in MCL1-Amplified, MYC-Amplified, CCNE1-Amplified Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying whether a new experimental cancer study drug BAY 1000394 will be helpful in treating solid tumor cancer with an abnormality in one of the following genes: Mcl-1, Myc or CCNE.

Detailed description

* This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. * "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. * It also means that the FDA (the U.S. Food and Drug Administration) has not approved BAY 1000394 for use in participants with your type of cancer. * The study drug is a pan-CDK inhibitor targeting the genetic defect in several tumors, MCL1, Myc, or CCNE.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BAY 1000394

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-10-01
• Completion: 2023-05-01
• First posted: 2016-01-15
• Last updated: 2016-07-01

Locations

1 site across 1 country: United States