A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Phase 3

• Conditions: Health Condition 1: D618- Other specified aplastic anemias and other bone marrow failure syndromes

• Registration Number: CTRI/2023/11/060327
• Lead Sponsor: CTI BioPharma Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008)

2. Average platelet count of <50,000/µL at Screening (Day -35 to Day -3) based on two measurements taken on different days; both measurements must be <50,000/µL

3. DIPSS Intermediate-1, Intermediate-2, or High risk (Passamonti et al 2010)

4. Palpable splenomegaly =5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination

5. TSS of =10 on the MPN-SAF TSS 2.0 or a single symptom score of =5 or two symptoms of =3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats

6. If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria:

- Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.

- Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less. The 270-day period starts on the date of first ruxolitinib administration and continues for 270 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.The patient may not have received >10 mg of ruxolitinib on any day during that interval.

7. Eastern Cooperative Oncology Group performance status 0 to 2

8. Peripheral blast count of <10% throughout the Screening period and at baseline

9. Absolute neutrophil count of =500/µL

10.Left ventricular cardiac ejection fraction of =50% by echocardiogram or multigated acquisition (MUGA) scan

Exclusion Criteria

1. Life expectancy <6 months

2. Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allo-SCT

3. History of splenectomy or planning to undergo splenectomy

4. Splenic irradiation within the last 6 months

5. Previously treated with pacritinib

6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1

7. Any prior treatment with more than one JAK2 inhibitor

8. Treatment with an experimental therapy within 28 days prior to treatment Day 1

9. Systemic treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1

10. Significant recent bleeding history defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade =2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)

Study & Design

• Study Type: Interventional
• Study Design: Not specified