Advanced CancerPhase 1NCT01393990

A Study of LY2228820 in Participants With Advanced Cancer

A Phase 1 study testing LY2228820, Midazolam and Tamoxifen in people with Advanced Cancer, run by Eli Lilly and Company at 2 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

The objective of this study is to determine a safe dose of LY2228820 that may be given to participants with advanced cancer. Part A of this study will consist of dose escalation, and Part B will consist of dose confirmation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer
What is being tested?: LY2228820, Midazolam and Tamoxifen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 2 sitesUnited States
Study dates: 4 Sep 2008to 14 Dec 2013
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 (including lymphoma) that is advanced or metastatic disease for which no therapy of higher priority (approved therapies or therapies with published substantial evidence of effectiveness) is available, or for whom no standard therapy exists
Have the presence of measurable or nonmeasurable disease as defined by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Have adequate hematologic, renal, and hepatic organ function
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 14 days (42 days for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug

Show all 9Show fewer

Females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of ≥ 12 weeks
Are able to swallow capsules and/or tablets

Who cannot join

Have received treatment within 14 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have a history of major surgical resection involving the stomach or small bowel, or have serious preexisting medical conditions (based on judgment of the investigator)
Have symptomatic central nervous system malignancy or metastasis (screening is not required)
Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Have an active hematologic malignancy other than lymphoma
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening at baseline will not be required for enrollment

Show all 9Show fewer

Concurrent administration of any immunosuppressive therapy
Females who are pregnant or lactating
Have received, within 7 days of the initial dose of study drug, either grapefruit juice or treatment with a drug that is a known inhibitor or inducer of Cytochrome P450 Enzyme 3A4 (CYP3A4). In addition, participants should not receive grapefruit juice or treatment with a CYP3A4 inhibitor or inducer during the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rochester, Minnesota
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Antonio, Texas

Other trials in United States

About this study

Official title: A Phase 1 Study of an Oral p38 MAPK Inhibitor in Patients With Advanced Cancer

Conditions: Advanced Cancer
Being tested: LY2228820, Midazolam, Tamoxifen

What participants receive

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

LY2228820Drug
Also called p38 MAP kinase
Administered orally
MidazolamDrug
TamoxifenDrug

Study groups in NCT01393990
Study group	Role	What they receive
LY2228820	Experimental	The study had 4 parts, dose-escalation (Part A), 2 dose-confirmation (Parts B and C), and a tumor-specific expansion for metastatic breast cancer (Part D). Part A: Participants received escalating doses of 10, 20, 40, 65, 90, 120, 160, 200, 300, 420 and 560 milligrams (mg) of LY2228820 every 12 hours on Days 1 through 14 of a 28-day cycle. Part B: Participants received 420 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Participants received midazolam orally 2 days before the first dose and again after the morning dose of study drug on Day 8 during the first cycle of treatment. Part C: Participants received 300 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Part D: Participants received 200 mg and 300 mg of LY2228820 in combination with tamoxifen. Receives: Drug: LY2228820; Drug: Midazolam; Drug: Tamoxifen

What is being measured

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

Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline to study completion (Up to 41 months)

Secondary outcomes (5)

Recommended Dose for Phase 2 Studies
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest dose level at which no more than 33% of participants experience a DLT during Cycle 1.
Measured: Baseline to study completion (Up to 41 months)
Percentage of Participants With Best Overall Response [Complete Response (CR)+Partial Response (PR)+Stable Disease (SD)]
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level in non-target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. PD was defined as having at least a 20% increase in the sum of the LD of target lesion and appearance of ≥1 new lesion and/or unequivocal progression of existing nontarget lesions. SD was defined as small changes that did not meet the above criteria taking as reference the smallest sum LD since treatment started.
Measured: Baseline to study completion (Up to 41 months)
PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820
Measured: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose
PK: Maximum Plasma Concentration (Cmax) of LY2228820
Measured: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose
Pharmacodynamics (PD): Number of Participants With Greater Than 50% Inhibition of p38 Mitogen-Activated Protein Kinase (MAPK) Activity on Day 1
The effect of LY2228820 on PD biomarker was measured as MAPK-activated protein kinase -2 (MAPKAP-K2) level which is regulated by p38 MAPK activity. Inhibition of p38 MAPK activity will result in lower levels of MAPKAPK-2.
Measured: Cycle 1 Day 1: predose, 1, 2, 4, and 6 h postdose

Timeline

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

4 Sep 200814 Dec 2013

First posted14 Jul 2011 (estimated)
Study start4 Sep 2008
Primary completionFeb 2013
Study completion14 Dec 2013

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 Advanced CancerStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01393990
Sponsor's protocol ID: 12284
Other IDs: I1D-MC-JIAD
Status last verified: Mar 2020
First submitted: 12 Jul 2011
Last updated: 24 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of an Oral p38 MAPK Inhibitor in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT01393990
Acronym / sponsor ID: 12284
Conditions: Advanced Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 4 Sep 2008 (actual)
Primary completion: Feb 2013 (actual)
Study completion: 14 Dec 2013 (actual)
First posted: 14 Jul 2011 (estimated)
Results: Posted 24 Mar 2020

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2228820	Experimental	Drug: LY2228820, Drug: Midazolam, Drug: TamoxifenThe study had 4 parts, dose-escalation (Part A), 2 dose-confirmation (Parts B and C), and a tumor-specific expansion for metastatic breast cancer (Part D). Part A: Participants received escalating doses of 10, 20, 40, 65, 90, 120, 160, 200, 300, 420 and 560 milligrams (mg) of LY2228820 every 12 hours on Days 1 through 14 of a 28-day cycle. Part B: Participants received 420 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Participants received midazolam orally 2 days before the first dose and again after the morning dose of study drug on Day 8 during the first cycle of treatment. Part C: Participants received 300 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Part D: Participants received 200 mg and 300 mg of LY2228820 in combination with tamoxifen.

Who may qualify

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

Key inclusion criteria (9 listed)

Have histological or cytological evidence of a diagnosis of cancer (including lymphoma) that is advanced or metastatic disease for which no therapy of higher priority (approved therapies or therapies with published substantial evidence of effectiveness) is available, or for whom no standard therapy exists
Have the presence of measurable or nonmeasurable disease as defined by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Have adequate hematologic, renal, and hepatic organ function
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 14 days (42 days for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy

Key exclusion criteria (9 listed)

Have received treatment within 14 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have a history of major surgical resection involving the stomach or small bowel, or have serious preexisting medical conditions (based on judgment of the investigator)
Have symptomatic central nervous system malignancy or metastasis (screening is not required)
Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Have an active hematologic malignancy other than lymphoma

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
LY2228820Also: p38 MAP kinaseAdministered orally	Drug	LY2228820
Midazolam	Drug	LY2228820
Tamoxifen	Drug	LY2228820

Primary outcome

Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)
Time frame: Baseline to study completion (Up to 41 months)
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

5 secondary outcomes

Recommended Dose for Phase 2 Studies
Time frame: Baseline to study completion (Up to 41 months)
Percentage of Participants With Best Overall Response [Complete Response (CR)+Partial Response (PR)+Stable Disease (SD)]
Time frame: Baseline to study completion (Up to 41 months)
PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820
Time frame: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose
PK: Maximum Plasma Concentration (Cmax) of LY2228820
Time frame: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose
Pharmacodynamics (PD): Number of Participants With Greater Than 50% Inhibition of p38 Mitogen-Activated Protein Kinase (MAPK) Activity on Day 1
Time frame: Cycle 1 Day 1: predose, 1, 2, 4, and 6 h postdose

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: 10 mg LY2228820 Capsules	4	3
Part A: 20 mg LY2228820 Capsules	3	3
Part A: 40 mg LY2228820 Capsules	3	3
Part A: 65 mg LY2228820 Capsules	3	2
Part A: 90 mg LY2228820 Capsules	5	3
Part A: 120 mg LY2228820 Capsules	3	2
Part A: 160 mg LY2228820 Capsules	3	2
Part A: 200 mg LY2228820 Capsules	7	6
Part A: 160 mg Bridge LY2228820	6	3
Part A: 160 mg LY2228820 Tablets	3	2
Part A: 200 mg LY2228820 Tablets	3	3
Part A: 300 mg LY2228820 Tablets	3	3
Part A: 420 mg LY2228820 Tablets	3	3
Part A: 560 mg LY2228820 Tablets	5	3
Part B: 420 mg LY2228820 Tablets	18	9
Part C: 300 mg LY2228820 Tablets	8	5
Part D: 200 mg LY2228820 Tablets	3	3
Part D: 300 mg LY2228820 Tablets	6	6

Primary outcome: Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)

Time frame: Baseline to study completion (Up to 41 months). Count of participants. Unit: Participants

Measure	Part A: 10 mg LY2228820 Capsules n = 4	Part A: 20 mg LY2228820 Capsules n = 3	Part A: 40 mg LY2228820 Capsules n = 3	Part A: 65 mg LY2228820 Capsules n = 3	Part A: 90 mg LY2228820 Capsules n = 5	Part A: 120 mg LY2228820 Capsules n = 3	Part A: 160 mg LY2228820 Capsules n = 3	Part A: 200 mg LY2228820 Capsules n = 7	Part A: 160 mg LY2228820 Bridge n = 6	Part A: 160 mg LY2228820 Tablets n = 3	Part A: 200 mg LY2228820 Tablets n = 3	Part A: 300 mg LY2228820 Tablets n = 3	Part A: 420 mg LY2228820 Tablets n = 3	Part A: 560 mg LY2228820 Tablets n = 5	Part B: 420 mg LY2228820 Tablets n = 18	Part C: 300 mg LY2228820 Tablets n = 8	Part D: 200 mg LY2228820 Tablets n = 3	Part D: 300 mg LY2228820 Tablets n = 6
Value	1	3	2	3	1	1	1	5	4	1	3	3	3	4	18	7	3	6

Population analysed: Any participant who received at least 1 dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 41 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: 10 mg LY2228820 Capsules	2 of 4 (50%)	3 of 4 (75%)	0 of 4
Part A: 20 mg LY2228820 Capsules	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A: 40 mg LY2228820 Capsules	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A: 65 mg LY2228820 Capsules	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A: 90 mg LY2228820 Capsules	3 of 5 (60%)	2 of 5 (40%)	1 of 5
Part A: 120 mg LY2228820 Capsules	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A: 160 mg LY2228820 Capsules	2 of 3 (66.7%)	2 of 3 (66.7%)	0 of 3
Part A: 200 mg LY2228820 Capsules	2 of 7 (28.6%)	6 of 7 (85.7%)	0 of 7
Part A: 160 mg LY2228820 Bridge	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
Part A: 160 mg LY2228820 Tablets	3 of 3 (100%)	3 of 3 (100%)	0 of 3
Part A: 200 mg LY2228820 Tablets	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A: 300 mg LY2228820 Tablets	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A: 420 mg LY2228820 Tablets	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A: 560 mg LY2228820 Tablets	3 of 5 (60%)	5 of 5 (100%)	1 of 5
Part B: 420 mg LY2228820 Tablets	7 of 18 (38.9%)	18 of 18 (100%)	1 of 18
Part C: 300 mg LY2228820 Tablets	4 of 8 (50%)	7 of 8 (87.5%)	0 of 8
Part D: 200 mg LY2228820 Tablets	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part D: 300 mg LY2228820 Tablets	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

2 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 LY2228820, Midazolam and Tamoxifen in people with Advanced Cancer, run by Eli Lilly and Company at 2 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 9 inclusion and 9 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 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 24 Mar 2020). 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?

Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests) (time frame: Baseline to study completion (Up to 41 months)). 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 NCT01393990.

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 24 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.