Active not recruiting

A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

I3Y-MC-JPCB - ClinicalTrials.gov - NCT02688088

The purpose of this study is to evaluate how abemaciclib interacts with a drug mixture containing caffeine, warfarin, dextromethorphan, and midazolam and how this interaction affects blood levels in the body.
How long will I be in the trial?
Your participation could last up to 4 months or longer if you continue to take the study drug.
Email
Active not recruiting

A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

I3Y-MC-JPCB - ClinicalTrials.gov - NCT02688088

The purpose of this study is to evaluate how abemaciclib interacts with a drug mixture containing caffeine, warfarin, dextromethorphan, and midazolam and how this interaction affects blood levels in the body.
How long will I be in the trial?
Your participation could last up to 4 months or longer if you continue to take the study drug.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have a diagnosis of cancer that is advanced and/or metastatic and is confirmed by histology or cytology

Participants must discontinue all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug

Participants must NOT

Participants must not have history or presence of significant bleeding disorders

Participants must not have known active uncontrolled or symptomatic CNS metastases

Participants must not have a primary liver tumor

Participants must not have lymphoma or leukemia

Trial Summary

Conditions the trial is for

Breast Cancer

What the trial is testing?

Abemaciclib + Drug Cocktail, Abemaciclib, Drug Cocktail (caffeine, warfarin, dextromenthorphan, and midazolam)

Could I receive a Placebo?

no

Enrollment Goal

48

Trial Dates

March 2016 - October 2020

Trial Phase

1

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Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have a diagnosis of cancer that is advanced and/or metastatic and is confirmed by histology or cytology

Participants must discontinue all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug

Participants must NOT

Participants must not have history or presence of significant bleeding disorders

Participants must not have known active uncontrolled or symptomatic CNS metastases

Participants must not have a primary liver tumor

Participants must not have lymphoma or leukemia

Trial Summary

Conditions the trial is for

Breast Cancer

What the trial is testing?

Abemaciclib + Drug Cocktail, Abemaciclib, Drug Cocktail (caffeine, warfarin, dextromenthorphan, and midazolam)

Could I receive a Placebo?

no

Enrollment Goal

48

Trial Dates

March 2016 - October 2020

Trial Phase

1

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Trial Locations

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Breast Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?