A Study in Myeloproliferative Disorders
Completed · Phase 1
Conditions studied: Myeloproliferative Disorders, Thrombocythemia, Essential, Polycythemia Vera, Primary Myelofibrosis
In brief
The purpose of this study is to find out the safe dose range of the study drug in patients with myeloproliferative disorders.
Key facts
- Study ID
- NCT01134120
- Run by
- Eli Lilly and Company
- People needed
- 80
- Starts
- 2010-04-01
- Expected to finish
- 2018-02-22
- Last updated by the study team
- 2018-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms and meet the following additional sub-type specific criteria:
- A. PV: has failed or is intolerant of standard therapies or refuses to take standard medications
- B. ET: has failed or is intolerant of standard therapies or refuses to take standard medications
- C. MF (patients with MF must meet at least one of the following):
- i. has intermediate or high-risk MF according to the Lille scoring system; or
- ii. has symptomatic MF with spleen greater than 10 cm below left costal margin; or
- iii. has post-polycythemic MF; or
- iv. has post-ET MF
- Have a quantifiable JAK2 V617F mutation
- Have discontinued all previous approved therapies for myeloproliferative disorders, including any chemotherapy, immunomodulating therapy (for example, thalidomide, interferon-alpha), immunosuppressive therapy (for example, corticosteroids greater than 10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin, thrombopoietin, or granulocyte colony stimulating factor 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 subject has been maintained on a stable dose for at least 4 weeks. Low-dose acetylsalicylic acid (aspirin) is permitted as well
You may not qualify if…
- 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
- Are currently being treated with agents that are metabolized by CYP3A4 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)
- Are currently being treated with warfarin or one of its derivatives which is known to alter levels of protein C or protein S. An exception to this criterion will be allowed for patients with a prior history of Budd-Chiari Syndrome who are being treated with warfarin or one of its derivatives
Where it is running
- 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. — Houston, Texas, United States
- 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, United States
Full record on ClinicalTrials.gov
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