LY2784544 for Blood Cancer

Recruiting at 43 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Hydroxyurea, Low-dose aspirin

Must not be taking: CYP3A4 agents, Warfarin

Disqualifiers: Heart failure, Infections, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

Will I have to stop taking my current medications?

Participants must stop taking all previous approved therapies for Myeloproliferative Neoplasms (MPNs) at least 14 days before starting the trial, except for hydroxyurea and low-dose aspirin, which are allowed if stable. If you are on medications metabolized by certain liver enzymes or on warfarin, you may need to stop those as well.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults with blood cancers like polycythemia vera, essential thrombocythemia, or myelofibrosis who haven't responded to or can't tolerate standard treatments (including ruxolitinib) may join. They should have a specific JAK2 mutation (except certain cohorts), be able to swallow pills, not be pregnant or breastfeeding, and agree to use contraception.

Inclusion Criteria

- Are able to swallow capsules

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 (Swerdlow et al. 2008) and meet the following additional subtype specific criteria:

- PV: have failed or is intolerant of standard therapies or refuses to take standard medications

Exclusion Criteria

Are currently enrolled in, or discontinued within the last 14 days from a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Have a corrected QT (QTc) interval >470 millisecond (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 disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 120 mg of LY2784544 orally once daily for 6 cycles

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY2784544

Trial Overview The trial is testing LY2784544 at 120 mg for those with myeloproliferative neoplasms who've had inadequate results from other therapies. It aims to see how well participants respond in terms of disease symptoms and progression.

Participant Groups

Group I: 120 mg LY2784544 Experimental Treatment 1 Intervention

120 milligram (mg) administered orally once daily for 6 cycles (168 days)

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University