Solid TumorPhase 1NCT01432951

A Study of Enzastaurin in Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma

A Phase 1 study testing Enzastaurin in people with Solid Tumor and Lymphoma, Malignant, run by Eli Lilly and Company at 3 sites in China.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to assess the pharmacokinetics (PK) of enzastaurin and its metabolites in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Information about any side effects that may occur will also be collected. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Lymphoma, Malignant
What is being tested?: Enzastaurin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 3 sitesChina
Study dates: Nov 2011to 5 Jan 2018
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 given written informed consent
Have a histologic or cytologic diagnosis of cancer (solid tumor or lymphoma) with clinical or radiologic evidence of locally advanced and/or metastatic disease for which no life-prolonging therapy exists. (Note: participants with glioblastoma, and other hematologic malignancies [except lymphoma] are excluded from this study.)
Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale and, in the investigator's opinion, are suitable for participation in the study
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 30 days prior to study entry (6 weeks for mitomycin-C or nitrosoureas), and have recovered from the acute effects of therapy
If the participants have hormone-refractory prostate cancer, the study doctor will discuss with the participants what drugs they would be allowed to continue to receive during the study

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Have adequate organ function, including:
Bone Marrow Reserve: absolute neutrophil count (ANC) greater than or equal to 1.5 × 10^9/Liter (L) prior to treatment, platelets greater than or equal to 100 × 10^9/L, and hemoglobin greater than or equal to 10 gram/deciliter (g/dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Participants may be allowed erythropoietin of choice as per standard of care.
Hepatic: bilirubin within 1.5 times the upper limit of normal (ULN), alanine transaminase, and aspartate transaminase less than or equal to 2.5 times ULN or less than or equal to 5 times ULN when liver metastases are known
Renal: serum creatinine less than or equal to 1.5 milligram/deciliter (mg/dL)
Electrolytes: Participants may be entered into the study if, in the investigator's opinion, any electrolyte disorders, including potassium less than 3.4 milliequivalents/liter (mEq/L), calcium less than 8.4 mg/dL, or magnesium less than 1.2 (mEq/L), may be appropriately managed and stabilized by the time of the laboratory evaluation on the lead-in day. If electrolytes have not been stabilized during this time, the participant will be discontinued from the study. Participants with hypercalcemia are excluded.
Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete the PK phase and at least 1 cycle of the safety extension phase (if the participant were to participate in the safety extension phase)

Who cannot join

Have received treatment within 28 days of the first dose of study drug with an experimental agent for non cancer indications that has not received regulatory approval for any indication
Participants with glioblastoma or hematologic malignancies other than lymphoma are excluded from this study. Participants who have central nervous system (CNS) metastases (unless the participant has completed successful local therapy.
for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy) are excluded. In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required.
Serious concomitant systemic disorder, including active infection, that is incompatible with the study (at the discretion of the investigator)
Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infections
Have a serious cardiac condition

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Have abnormal electrocardiogram (ECG) findings, at the discretion of the investigator
Use medications that are known to cause certain changes in electrocardiogram (ECG) readings
Have a history of unexplained syncope (fainting or passing out) within the last year, or have a known family history of unexplained sudden death
Have had a complete gastrectomy or other significant gastrointestinal diseases that, in the investigator's opinion, may significantly impact drug absorption
Are receiving total parenteral nutrition
Are not able to swallow tablets
Are a woman who is breast feeding, lactating, or pregnant
Are allergic to enzastaurin
Are receiving herbal regimens
Drugs and herbal supplements that are known to be potent or moderate inhibitors or inducers of cytochrome P450 (CYP)3A are specifically excluded. Foods that are known to be potent or moderate inhibitors of CYP3A (for example, grapefruit, grapefruit juice, Seville oranges, or Seville orange juice) are also specifically excluded during the study. In addition, starfruit and starfruit juice are excluded during the PK phase of the study.
Drugs with narrow therapeutic windows that are also known substrates of CYP2C9, CYP2C8, CYP2C19, and CYP3A are excluded
Have an average weekly alcohol intake that exceeds 21 units per week (men) and 14 units per week (women) or are unwilling to stop alcohol consumption from the lead-in day through the completion of collecting samples for study drug measurement (1 unit = 12 oz or 360 milliliter (mL) of beer; 5 ounces (oz) or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Use of drugs of abuse, as evidenced by history and/or positive findings on urinary drug screening, unless prescribed by a physician (for example, narcotic pain medication)
The investigator thinks you should not participate for any reason

Trial locations and contacts

3 sites in 1 country.

China3 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.
Beijing, 100071
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.
Changsha, 410013
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.
Guangzhou, 510060

Other trials in China

About this study

Official title: Pharmacokinetics of Enzastaurin HCl in Native Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma

This is a Phase 1 study of enzastaurin in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Participants will receive daily doses of enzastaurin for 14 days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Participants may be allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an opportunity for a participant's oncologist to assess the potential benefit of the participant continuing to receive enzastaurin in the safety extension phase. There is no planned duration for the extension phase; participants are allowed to continue receiving enzastaurin until disease progression or other reason for discontinuation as per the investigator's assessment.

Conditions: Solid Tumor, Lymphoma, Malignant
Being tested: Enzastaurin
Medical subject headings: Lymphoma

What participants receive

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

EnzastaurinDrug
Also called LY317615
Administered orally

Study groups in NCT01432951
Study group	Role	What they receive
Enzastaurin	Experimental	Enzastaurin 500 mg, four 125-mg tablets administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin for an additional 2 to 4 weeks. Safety Extension: Participants had the option to continue receiving enzastaurin until disease progression or discontinuation criteria are met, as per the investigator's assessment. Receives: Drug: Enzastaurin

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
PK (AUCt,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Measured: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
PK (Cmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Measured: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
PK (tmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Measured: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
PK (Cav,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Measured: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
PK terminal elimination half-life of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
Measured: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose

Timeline

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

Nov 20115 Jan 2018

First posted13 Sep 2011 (estimated)
Study startNov 2011
Primary completion11 Jan 2013
Study completion5 Jan 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01432951
Sponsor's protocol ID: 13322
Other IDs: H6Q-FW-JCCC
Status last verified: Sep 2020
First submitted: 9 Sep 2011
Last updated: 12 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Li X, Fang X, Li S, Zhang W, Yang N, Cui Y, Huang H, Cai R, Lin X, Fu X, Hong H, Lin T. A pharmacokinetic and safety study of a fixed oral dose of enzastaurin HCl in native Chinese patients with refractory solid tumors and lymphoma. Oncotarget. 2016 Apr 5;7(14):18585-93. doi: 10.18632/oncotarget.7875.
PubMed 26942463

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 Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Enzastaurin HCl in Native Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma
ClinicalTrials.gov ID: NCT01432951
Acronym / sponsor ID: 13322
Conditions: Solid Tumor, Lymphoma, Malignant
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: 11 Jan 2013 (actual)
Study completion: 5 Jan 2018 (actual)
First posted: 13 Sep 2011 (estimated)
Results: Posted 2 Sep 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Enzastaurin	Experimental	Drug: EnzastaurinEnzastaurin 500 mg, four 125-mg tablets administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin for an additional 2 to 4 weeks. Safety Extension: Participants had the option to continue receiving enzastaurin until disease progression or discontinuation criteria are met, as per the investigator's assessment.

Who may qualify

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

Key inclusion criteria (12 listed)

Have given written informed consent
Have a histologic or cytologic diagnosis of cancer (solid tumor or lymphoma) with clinical or radiologic evidence of locally advanced and/or metastatic disease for which no life-prolonging therapy exists. (Note: participants with glioblastoma, and other hematologic malignancies [except lymphoma] are excluded from this study.)
Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale and, in the investigator's opinion, are suitable for participation in the study
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 30 days prior to study entry (6 weeks for mitomycin-C or nitrosoureas), and have recovered from the acute effects of therapy

Key exclusion criteria (20 listed)

Have received treatment within 28 days of the first dose of study drug with an experimental agent for non cancer indications that has not received regulatory approval for any indication
Participants with glioblastoma or hematologic malignancies other than lymphoma are excluded from this study. Participants who have central nervous system (CNS) metastases (unless the participant has completed successful local therapy.
for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy) are excluded. In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required.
Serious concomitant systemic disorder, including active infection, that is incompatible with the study (at the discretion of the investigator)
Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infections

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
EnzastaurinAlso: LY317615Administered orally	Drug	Enzastaurin

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK (AUCt,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Time frame: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK (Cmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK (tmax,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Time frame: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK (Cav,ss) of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.
PK: Terminal Elimination Half-Life of Enzastaurin, It's Metabolites and Total Analytes in Plasma
Time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose
PK terminal elimination half-life of Enzastaurin, its metabolites (LSN326020, LSN485912, and LSN2406799), and total analyte in plasma (enzastaurin + LSN326020 + LSN485912 + LSN2406799) were reported.

Results and safety

Results posted to the registry on 2 Sep 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
Enzastaurin	26	25

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma

Time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole*hour/Liter (nmol*h/L)

Measure	Enzastaurin n = 23
Enzastaurin	29100 (128)
LSN326020	21800 (45.5)
LSN485912	6520 (145)
LSN2406799	2910 (103)
Total Analytes	63700 (86.1)

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

Primary outcome: PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma

Time frame: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole/liter (nmol/L)

Measure	Enzastaurin n = 23
Enzastaurin	2370 (112)
LSN326020	1070 (38.4)
LSN485912	385 (116)
LSN2406799	265 (89.8)
Total Analytes	4140 (81.5)

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

Primary outcome: PK: Time of Maximal Plasma Concentration at Steady State (Tmax, ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma

Time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose. Median (Full Range). Unit: Hour (h)

Measure	Enzastaurin n = 23
Enzastaurin	4.00 (2.00 to 8.17)
LSN326020	5.97 (0.00 to 24.00)
LSN485912	6.00 (0.00 to 24.00)
LSN2406799	4.00 (2.00 to 8.17)
Total Analytes	4.00 (2.00 to 8.17)

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

Primary outcome: PK: Average Concentration During a Dosing Interval at Steady State (Cav,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma

Time frame: Day 14: Predose and and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Enzastaurin n = 23
Enzastaurin	1210 (128)
LSN326020	907 (45.5)
LSN485912	272 (145)
LSN2406799	121 (103)
Total Analytes	2650 (86.1)

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

Adverse events

Time frame: From Baseline to Study Completion (Up to 6 years and 1 month). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enzastaurin	0 of 25 (0%)	19 of 25 (76%)	Not reported
Enzastaurin Safety Extension	0 of 15 (0%)	9 of 15 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26942463Li X, Fang X, Li S, Zhang W, Yang N, Cui Y, Huang H, Cai R, Lin X, Fu X, Hong H, Lin T. A pharmacokinetic and safety study of a fixed oral dose of enzastaurin HCl in native Chinese patients with refractory solid tumors and lymphoma. Oncotarget. 2016 Apr 5;7(14):18585-93. doi: 10.18632/oncotarget.7875.

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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

3 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 Enzastaurin in people with Solid Tumor and Lymphoma, Malignant, run by Eli Lilly and Company at 3 sites in China.

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 12 inclusion and 20 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 2 Sep 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?

Pharmacokinetics (PK): Area Under the Concentration -Time Curve Over a Dosing Interval at Steady State (AUCt,ss) of Enzastaurin, It's Metabolites and Total Analytes in Plasma (time frame: Day 14: Predose and 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours post dose). The study lists 5 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 NCT01432951, which also lists 1 linked publication.

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 12 Oct 2020.