Neoplasm MetastasisPhase 1NCT02688088

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

A Phase 1 study testing Drug Cocktail and Abemaciclib in people with Neoplasm Metastasis, run by Eli Lilly and Company at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasm Metastasis
What is being tested?: Drug Cocktail and Abemaciclib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 5 sitesUnited States
Study dates: 8 Mar 2016to 6 Jan 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic
Have adequate organ function
Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued 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 and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia

Who cannot join

Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2
History or presence of significant bleeding disorders
Have known active uncontrolled or symptomatic CNS metastases
Have a primary liver tumor
Have lymphoma or leukemia

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Mary Crowley Cancer Research Center
Dallas, Texas, 75230
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
University of Kansas Hospital
Fairway, Kansas, 66160
IU Simon Cancer Center
Indianapolis, Indiana, 46202
South Texas Accelerated Research Therapeutics, LCC
San Antonio, Texas, 78229-3307

Other trials in United States

About this study

Official title: Effects of Multiple Doses of Abemaciclib on the Pharmacokinetics of Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2D6, and CYP3A Substrates (Caffeine, Warfarin, Dextromethorphan, and Midazolam) in Cancer Patients

This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

Conditions: Neoplasm Metastasis
Being tested: Drug Cocktail, Abemaciclib
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug CocktailDrug
Also called Caffeine + Warfarin + Dextromethorphan + Midazolam
Administered orally
AbemaciclibDrug
Also called LY2835219
Administered orally

Study groups in NCT02688088
Study group	Role	What they receive
Drug Cocktail - Period 1	Active comparator	Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1. Receives: Drug: Drug Cocktail
200 mg Abemaciclib + Drug Cocktail - Period 2	Experimental	200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2. Receives: Drug: Drug Cocktail; Drug: Abemaciclib
200 mg Abemaciclib - Period 3	Experimental	200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met. Receives: Drug: Abemaciclib
200 mg Abemaciclib - Period 4	Experimental	200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met. Receives: Drug: Abemaciclib
Safety Extension Period	Experimental	200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met. Receives: Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose
Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: 1, 2, 4, 6, 8, 10, 24, 48, 72 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Measured: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose

Secondary outcomes (6)

Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Measured: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Measured: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.
Measured: Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.
Measured: Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Measured: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Measured: Day 8: Baseline, 24 h postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 20166 Jan 2021

First posted23 Feb 2016 (estimated)
Study start8 Mar 2016
Primary completion4 Feb 2018
Study completion6 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688088
Sponsor's protocol ID: 15537
Other IDs: I3Y-MC-JPCB
Status last verified: 1 Apr 2022
First submitted: 17 Feb 2016
Last updated: 18 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasm Metastasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Multiple Doses of Abemaciclib on the Pharmacokinetics of Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2D6, and CYP3A Substrates (Caffeine, Warfarin, Dextromethorphan, and Midazolam) in Cancer Patients
ClinicalTrials.gov ID: NCT02688088
Acronym / sponsor ID: 15537
Conditions: Neoplasm Metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 8 Mar 2016 (actual)
Primary completion: 4 Feb 2018 (actual)
Study completion: 6 Jan 2021 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 18 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Drug Cocktail - Period 1	Active comparator	Drug: Drug CocktailSingle dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
200 mg Abemaciclib + Drug Cocktail - Period 2	Experimental	Drug: Drug Cocktail, Drug: Abemaciclib200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
200 mg Abemaciclib - Period 3	Experimental	Drug: Abemaciclib200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met.
200 mg Abemaciclib - Period 4	Experimental	Drug: Abemaciclib200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met.
Safety Extension Period	Experimental	Drug: Abemaciclib200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic
Have adequate organ function
Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued 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 and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia

Key exclusion criteria (5 listed)

Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2
History or presence of significant bleeding disorders
Have known active uncontrolled or symptomatic CNS metastases
Have a primary liver tumor
Have lymphoma or leukemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug CocktailAlso: Caffeine + Warfarin + Dextromethorphan + MidazolamAdministered orally	Drug	200 mg Abemaciclib + Drug Cocktail - Period 2, Drug Cocktail - Period 1
AbemaciclibAlso: LY2835219Administered orally	Drug	200 mg Abemaciclib + Drug Cocktail - Period 2, 200 mg Abemaciclib - Period 3, 200 mg Abemaciclib - Period 4, Safety Extension Period

Primary outcome

Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine
Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin
Time frame: Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan
Time frame: Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam
Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine
Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr Postdose
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin
Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr Postdose
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan
Time frame: Days 1 and 8: 1, 2, 4, 6, 8, 10, 24, 48, 72 hr Postdose
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam
Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

6 secondary outcomes

Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Time frame: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1
Time frame: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Time frame: Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Time frame: Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Time frame: Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Time frame: Day 8: Baseline, 24 h postdose

Results and safety

Results posted to the registry on 18 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug Cocktail - Period 1	44	44
200 mg Abemaciclib + Drug Cocktail - Period 2	0	0
200 mg Abemaciclib - Period 3	0	0
200 mg Abemaciclib Period - 4	0	0
Abemaciclib Safety Extension Period	0	0

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine

Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	100 mg Caffeine n = 39	Abemaciclib + 100 mg Caffeine n = 32
Value	2890 (29)	2950 (33)

100 mg Caffeine vs Abemaciclib + 100 mg Caffeine: Ratio of Geometric LS Means: 1.01 (90% CI 0.965 to 1.06)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin

Time frame: Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	10 mg Warfarin n = 44	200 mg Abemaciclib + 10 mg Warfarin n = 30
Value	561 (35)	526 (35)

10 mg Warfarin vs 200 mg Abemaciclib + 10 mg Warfarin: Ratio of Geometric LS Means: 0.935 (90% CI 0.871 to 1.00)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan

Time frame: Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	30 mg Dextromethorphan n = 43	200 Abemaciclib + 30 mg Dextromethorphan n = 36
Value	3.18 (182)	3.30 (164)

30 mg Dextromethorphan vs 200 Abemaciclib + 30 mg Dextromethorphan: Ratio of Geometric LS Means: 1.05 (90% CI 0.898 to 1.22)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam

Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	0.2 mg Midazolam (Drug Cocktail) n = 44	200 mg Abemaciclib + 0.2 mg Midazolam n = 39
Value	2.12 (54)	1.75 (48)

0.2 mg Midazolam (Drug Cocktail) vs 200 mg Abemaciclib + 0.2 mg Midazolam: Ratio of Geometric LS Means: 0.845 (90% CI 0.760 to 0.940)

Population analysed: All subjects who received at least one dose of study drug and had evaluable PK data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 46 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug Cocktail - Period 1	1 of 44 (2.3%)	22 of 44 (50%)	1 of 44
200 mg Abemaciclib - Period 2	3 of 42 (7.1%)	33 of 42 (78.6%)	0 of 42
200 mg Abemaciclib + Drug Cocktail - Period 2	2 of 35 (5.7%)	26 of 35 (74.3%)	0 of 35
200 mg Abemaciclib - Periods 3 and 4	6 of 28 (21.4%)	25 of 28 (89.3%)	0 of 28
Abemaciclib Safety Extension Period	2 of 18 (11.1%)	16 of 18 (88.9%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the BodyLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug Cocktail and Abemaciclib in people with Neoplasm Metastasis, run by Eli Lilly and Company at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine (time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.