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A Phase 1 Study of LY2784544 Testing Alternative Dosing Regimens in Patients With Myeloproliferative Neoplasms


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myeloproliferative Neoplasms of, Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis

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Trial Information

A Phase 1 Study of LY2784544 Testing Alternative Dosing Regimens in Patients With Myeloproliferative Neoplasms


Inclusion Criteria:



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)

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

Exclusion Criteria:

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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with LY2784544 dose limiting toxicities (DLT)

Outcome Time Frame:

Baseline through Cycle 1 in Part A (28 day cycles)

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14539

NCT ID:

NCT01520220

Start Date:

June 2012

Completion Date:

March 2015

Related Keywords:

  • Myeloproliferative Neoplasms of
  • Polycythemia Vera
  • Essential Thrombocythemia
  • Myelofibrosis
  • Primary Myelofibrosis
  • Neoplasms
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

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  35294
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.Phoenix, Arizona  85012
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  32256
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.Greenville, South Carolina  29605
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  84106
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.Marshfield, Wisconsin  54449
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.Little Rock, Arkansas  72205
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.Washington, District of Columbia  20007