Georgia's Online Cancer Information Center

Find A Clinical Trial

Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03935555
Protocol IDs
PU-H71-01-003 (primary)
NCI-2019-03010
Study Sponsor
Samus Therapeutics LLC

Summary

This is a multicenter, Phase 1b study with dose escalation and expansion cohorts designed to
assess the safety, tolerability, PK, and preliminary efficacy of PU-H71 in subjects with PMF,
Post-PV MF, Post-ET MF, taking stable doses of ruxolitinib.

Objectives

The study will employ a standard 3+3 dose escalation design to determine maximum tolerated
dose (MTD) and recommended Phase 2 dose (RP2D), with additional subjects treated in a dose
expansion cohort. The time period for collecting dose limiting toxicities (DLTs) is 1 cycle
(21 days).

Eligibility

  1. Subject is willing and able to provide written informed consent before any study-specific procedures are performed.
  2. Subject is willing to comply with all study procedures and restrictions.
  3. Subject is =18 years of age.
  4. Subject has confirmed diagnosis of PMF, Post-PV MF, or Post-ET MF.
  5. Subject has been receiving ruxolitinib therapy meeting the following criteria:
  6. Receiving ruxolitinib >3 months prior to enrollment.
  7. Stable dose for 8 weeks before starting therapy with PU-H71.
  8. Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of: • Persistent or worsening disease-related symptoms, including but not limited to fatigue, pruritus, night sweats, early satiety, and other symptoms as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score of >12 points. AND • Documented splenomegaly of at least 5 cm below the costal margin as measured on inspiration by physical examination.
  9. Subject has an Eastern Cooperative Oncology Group performance status of 0 to 2.
  10. Acceptable pre-study organ function during screening defined as:
  11. Absolute neutrophil count (ANC) =1000/µL.
  12. Platelet count =50,000/µL.
  13. Alanine aminotransferase or aspartate aminotransferase =2×upper limit of normal.
  14. Direct serum bilirubin = 1.5×upper limit of normal.
  15. Creatinine clearance >50 mL/min/1.73 m2 based on the Cockcroft Gault equation.
  16. If female and of childbearing potential (premenopausal and not surgically sterile), the subject:
  17. Must have a negative serum or urine pregnancy test at screening. The serum pregnancy test must be obtained prior to the first administration of PU-H71 (=72 hours prior to dosing) in all premenopausal women and women <2 years after the onset of menopause.
  18. Must agree to use an acceptable method of effective contraception for the duration of the study and for 13 weeks after receiving the last dose of study treatment.
  19. If male, the subject agrees to:
  20. Use an acceptable method of effective contraception for the duration of the study and for 13 weeks after receiving study treatment.
  21. Agrees to abstain from sperm donation for the duration of the study and for 13 weeks after receiving the last dose of study treatment
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.