Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer

NCT04635059 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO00040162
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label study using pacritinib for patients with histologically confirmed prostate adenocarcinoma, status post definitive treatment and biochemical recurrence.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Six-month PSA Progression-free Survival.

  PSA progression-free survival is defined as the length of time that a subject will be alive and free from PSA progression per PCWG3 guidelines.

  Six months

Secondary Outcomes (2)

• PSA Levels

  Cycle1Day1 (month 0), every month up to month 4.

• Testosterone Measurement

  Baseline and three months

Study Arms (1)

Pacritinib

EXPERIMENTAL

Pacritinib is an oral drug.

Drug: Pacritinib

Interventions

Pacritinib DRUG

Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).

Also known as: SB1518

Pacritinib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Prior radical prostatectomy or definitive radiation.
• Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry (calculated per Memorial Sloan Kettering Cancer Center (MSKCC) prostate nomogram: https://www.mskcc.org/nomograms/prostate/psa\_doubling\_time). Calculation of PSA doubling time should include the use of all available PSA values obtained within the past 12 months prior to randomization, with a minimum of three values separated by at least two weeks apart. The PSA values used to calculate the PSA doubling time must all be ≥ 0.1 ng/mL and should be measured in the same laboratory whenever feasible.
• Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient comorbidities. (N/A for patients who underwent definitive radiation therapy).
• Screening PSA \> 0.5 ng/mL.
• No definitive evidence of metastases on screening computerized tomography scan (CT) or magnetic resonance imaging (MRI) of abdomen/pelvis and radionuclide whole-body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 1.5 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. prostate specific membrane antigen (PSMA) or choline positron emission tomography (PET)) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
• Screening serum testosterone \> 150 ng/dL.
• Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 or Karnofsky Performance Status ≥ 70.
• No prior Janus Kinase 2 (JAK2) inhibitor treatment.
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
• Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent
• Ability to understand a written informed consent document, and the willingness to sign it.
• Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
• Adequate organ function as defined by the following laboratory values at screening:

You may not qualify if:

• Previously treated with pacritinib.
• Prior systemic treatment with androgen deprivation therapy and/or first-generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior androgen deprivation therapy (ADT) and/or first-generation anti-androgen in the (neo)adjuvant, definitive and/or salvage setting in conjunction with radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is \> 9 months prior to the date of randomization and the total duration of prior therapy is ≤ 36 months.
• Prior treatment with 17α-hydroxy / 17,20-lyase (CYP17) inhibitor (e.g., ketoconazole, abiraterone acetate, galeterone) or next-generation androgen receptor antagonist including apalutamide or enzalutamide.
• Prior chemotherapy for prostate cancer except if administered in the neoadjuvant or adjuvant setting and last dose \<= 6 months from randomization.
• Use of 5-alpha reductase inhibitor within 42 days prior to randomization.
• Use of investigational agents within 28 days prior to randomization.
• Use of other prohibited medications within seven days prior to Cycle 1 Day 1 on study (see Appendix 3 and 4 for list of prohibited medications).
• Systemic treatment with a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or a strong cytochromes P450 (CYP450) inducer within 14 days prior to treatment Day 1.
• Prior bilateral orchiectomy.
• Uncontrolled hypertension.
• Baseline severe hepatic impairment (Child-Pugh Class B \& C).
• An intercurrent illness that is not controlled, such as active infection, psychiatric illness/social situations that would limit compliance with study requirements.
• Any chronic medical condition requiring a higher dose of corticosteroid than an equivalent of 10 mg prednisone/prednisolone per day.
• Significant recent bleeding history, as defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade≥2 within three months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)
• Systemic treatment with medications that increase the risk of bleeding, including anticoagulants (warfarin, direct oral anticoagulant, etc.), antiplatelet agents (except for aspirin dosages of ≤ 100mg/day), vascular endothelial growth factor (anti-VEGF) agents, and daily use of COX-1 inhibiting nonsteroidal anti-inflammatory agents (NSAIDs) within 14 days prior to treatment Day 1.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Deepak Kilari, MD
• Organization: Medical College of Wisconsin

dkilari@mcw.edu

414-805-4600

Study Officials

• Deepak Kilari, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 18, 2020
• Study Start: June 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: October 27, 2024
• Last Updated: November 17, 2025
• Results First Posted: December 17, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)