Myeloproliferative Neoplasms ofPhase 1NCT01520220
Study of LY2784544 Testing Alternative Dosing in Participants With Myeloproliferative Neoplasms
A Phase 1 study testing LY2784544 in people with Myeloproliferative Neoplasms of and Polycythemia Vera, run by Eli Lilly and Company at 9 sites in United States.
Trial summary
The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms of, Polycythemia Vera, Essential Thrombocythemia
- What is being tested?
- LY2784544
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2012to 24 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF, primary or secondary) PV and ET participants must have failed or are intolerant of standard therapies or refuse to take standard medications
- MF participants must meet at least one of the following criteria:
- Have intermediate-1, intermediate-2, or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPSS) plus; or
- Have symptomatic MF with spleen greater than 10 cm below left costal margin; or
- Have post-polycythemic MF (post-PV MF); or
- Have post-essential thrombocythemic MF (post-ET MF)
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- All participants must meet the following criteria:
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function, including:
- Hepatic: Direct bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine transaminase (ALT), and aspartate transaminase (AST) less than or equal to 2.5 times ULN
- Renal: Serum creatinine less than or equal to 1.5 times ULN
- Bone Marrow Reserve: Absolute neutrophil count (ANC) ≥1000/mcL, platelets ≥25,000/mcL, platelets ≥50,000 for PV or ET participants.
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous approved therapies for MF, including any chemotherapy, immunomodulating therapy (for example, thalidomide, interferon-alpha), immunosuppressive therapy (for example, corticosteroids >10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin, thrombopoietin, or granulocyte colony-stimulating factor (GSF) for at least 14 days and recovered from the acute effects of therapy. Hydroxyurea used to control blood cell counts is permitted at study entry if the participant has been maintained on a stable dose for at least 4 weeks. Low dose acetylsalicylic acid (aspirin; 81 or 100 mg) is permitted as well
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug
- Females with child-bearing potential must have had a negative urine pregnancy test less than or equal to 7 days before the first dose of study drug and must also not be breastfeeding
- Are able to swallow capsules/tablets
- For participants who have undergone recent major surgery, at least 28 days must have elapsed between surgery and study participation, and the participant must have achieved, in the opinion of the treating physician, at least a good recovery from the surgical procedure
Who cannot join
- Potential participants may not be included in the study if any of the following apply during screening:
- Have received treatment within 14 days of the initial dose of study drug with an experimental agent that has not received regulatory approval for any indication
- Have a QTc interval >470 milliseconds (msec) using Bazett's formula
- Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in the study (for example, a gastrointestinal (GI) disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome)
- Are currently being treated with agents that are metabolized by cytochrome P450 (CYP)3A4 with a narrow therapeutic margin (for example, alfentanil, cyclosporine,diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
- Have received a hematopoietic stem cell transplant
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- Have a second primary malignancy that in the judgment of the investigator and sponsor, may affect the interpretation of the results
- Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)
- Have a history of congestive heart failure with New York Heart Association (NYHA) Class greater than 2 (NYHA Class 1 and 2 are eligible), unstable angina, recent myocardial infarction (within 6 months prior to administration of study drug), or documented history of ventricular arrhythmia
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 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.
Birmingham, Alabama, 35249
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.
Charleston, South Carolina, 29425
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.
Fayetteville, Arkansas, 72703
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.
Honolulu, Hawaii, 96813
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.
Jacksonville, Florida, 32224
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.
Milwaukee, Wisconsin, 53226
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.
Salt Lake City, Utah, 84132
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.
Scottsdale, Arizona, 85259
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.
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1 Study of LY2784544 Testing Alternative Dosing Regimens in Patients With Myeloproliferative Neoplasms
The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms.
- Conditions
- Myeloproliferative Neoplasms of, Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- Being tested
- LY2784544
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2784544Drug
LY2784544 will be taken by mouth per a specified schedule. Each cycle is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY2784544 Dosing Regimen A | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. Receives: Drug: LY2784544 |
| Part A: LY2784544 Dosing Regimen B | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. Receives: Drug: LY2784544 |
| Part B: LY2784544 Dosing Regimen A | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. Receives: Drug: LY2784544 |
| Part B: LY2784544 Dosing Regimen B | Experimental | LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. Receives: Drug: LY2784544 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with LY2784544 dose limiting toxicities (DLT)
Measured: Baseline through Cycle 1 in Part A (28 day cycles)
Recommended dose range and regimen for Phase 2 studies
Measured: Baseline through Cycle 1 in Part B (28 day cycles)
Secondary outcomes (6)
Pharmacokinetics of LY2784544: Maximum concentration (Cmax)
Measured: Cycle 1 in Part A and Part B (28 day cycles)
Pharmacokinetics of LY2784544: Area under the concentration-time curve (AUC)
Measured: Cycle 1 in Part A and Part B (28 day cycles)
International Working Group (IWG) response
Measured: Baseline through last Cycle in Part A and Part B (28 day cycles)
Dynamic International Prognostic Scoring System (DIPSS) Plus
Measured: Baseline through last Cycle in Part A and Part B (28 day cycles)
Change in symptom burden as assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Measured: Baseline, Last Cycle in Part A and Part B
Change in Myeloproliferative Neoplasm (MPN) Physician Symptom Assessment
Measured: Baseline, Last Cycle in Part A and Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study start11 Jun 2012
- Primary completion26 Jun 2015
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative Neoplasms ofStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520220
- Sponsor's protocol ID
- 14539
- Other IDs
- I3X-MC-JHTC
- Status last verified
- Apr 2017
- First submitted
- 10 Jan 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY2784544 Testing Alternative Dosing Regimens in Patients With Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT01520220
- Acronym / sponsor ID
- 14539
- Conditions
- Myeloproliferative Neoplasms of, Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2012 (actual)
- Primary completion
- 26 Jun 2015 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: LY2784544 Dosing Regimen A | Experimental | Drug: LY2784544LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. |
| Part A: LY2784544 Dosing Regimen B | Experimental | Drug: LY2784544LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days. |
| Part B: LY2784544 Dosing Regimen A | Experimental | Drug: LY2784544LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. |
| Part B: LY2784544 Dosing Regimen B | Experimental | Drug: LY2784544LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF, primary or secondary) PV and ET participants must have failed or are intolerant of standard therapies or refuse to take standard medications
- Have intermediate-1, intermediate-2, or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPSS) plus; or
- Have symptomatic MF with spleen greater than 10 cm below left costal margin; or
- Have post-polycythemic MF (post-PV MF); or
- Have post-essential thrombocythemic MF (post-ET MF)
Key exclusion criteria (9 listed)
- Potential participants may not be included in the study if any of the following apply during screening:
- Have received treatment within 14 days of the initial dose of study drug with an experimental agent that has not received regulatory approval for any indication
- Have a QTc interval >470 milliseconds (msec) using Bazett's formula
- Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in the study (for example, a gastrointestinal (GI) disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome)
- Are currently being treated with agents that are metabolized by cytochrome P450 (CYP)3A4 with a narrow therapeutic margin (for example, alfentanil, cyclosporine,diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
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 |
|---|---|---|
| LY2784544LY2784544 will be taken by mouth per a specified schedule. Each cycle is 28 days. | Drug | Part A: LY2784544 Dosing Regimen A, Part A: LY2784544 Dosing Regimen B, Part B: LY2784544 Dosing Regimen A, Part B: LY2784544 Dosing Regimen B |
Primary outcome
Number of participants with LY2784544 dose limiting toxicities (DLT)
Time frame: Baseline through Cycle 1 in Part A (28 day cycles)
Recommended dose range and regimen for Phase 2 studies
Time frame: Baseline through Cycle 1 in Part B (28 day cycles)
6 secondary outcomes
Pharmacokinetics of LY2784544: Maximum concentration (Cmax)
Time frame: Cycle 1 in Part A and Part B (28 day cycles)
Pharmacokinetics of LY2784544: Area under the concentration-time curve (AUC)
Time frame: Cycle 1 in Part A and Part B (28 day cycles)
International Working Group (IWG) response
Time frame: Baseline through last Cycle in Part A and Part B (28 day cycles)
Dynamic International Prognostic Scoring System (DIPSS) Plus
Time frame: Baseline through last Cycle in Part A and Part B (28 day cycles)
Change in symptom burden as assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Time frame: Baseline, Last Cycle in Part A and Part B
Change in Myeloproliferative Neoplasm (MPN) Physician Symptom Assessment
Time frame: Baseline, Last Cycle in Part A and Part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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
9 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 LY2784544 in people with Myeloproliferative Neoplasms of and Polycythemia Vera, run by Eli Lilly and Company at 9 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 19 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 LY2784544 dose limiting toxicities (DLT) (time frame: Baseline through Cycle 1 in Part A (28 day cycles)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2017.