An Open Label, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Patients With Myelofibrosis

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat sodium in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and clinical activity of the R2PD of imetelstat sodium in combination with ruxolitinib or other Janus Kinase (JAK) inhibitors in participants with MF in Part 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of primary myelofibrosis (PMF) according to the revised World Health Organization (WHO) criteria or post-essential thrombocythemia-MF or post-polycythemia vera according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria.

• Dynamic International Prognostic Scoring System (DIPSS) intermediate-1, intermediate-2 or high-risk MF.

• Candidate for ruxolitinib treatment:

‣ Part 1 participants: On ruxolitinib treatment for at least 12 weeks with at least 4 consecutive weeks immediately prior to enrollment at a stable dose.

⁃ Part 2 participants: Candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor (Cohort A) OR currently receiving JAK inhibitor treatment per standard of care for at least 12 weeks (maximum 48 weeks) with at least 4 consecutive weeks at a stable dose prior to enrollment (Cohort B).

• Clinical signs/symptoms of MF demonstrated by one of the following:

‣ Measurable splenomegaly demonstrated by either a palpable spleen measuring ≥5 cm below the left costal margin or a spleen volume ≥450 cm\^3 by MRI or CT, AND

⁃ active symptoms of MF on the MFSAF v4.0.

• Ineligible for or unwilling to undergo hematopoietic stem cell transplant at time of study entry.

• Hematology laboratory test values within protocol defined limits.

• Biochemical laboratory test values within protocol defined limits.

• Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.

• Participants should follow protocol defined contraceptives procedures.

• A woman of childbearing potential must have a negative serum or urine pregnancy test at screening.

Locations
United States
California
City of Hope
RECRUITING
Duarte
City of Hope
RECRUITING
Irvine
Florida
University of Miami
RECRUITING
Coral Gables
H. Lee Moffitt Cancer Center and Research Institute, Inc.
RECRUITING
Tampa
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Texas
Texas Oncology
RECRUITING
Denison
Texas Oncology
RECRUITING
Tyler
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Shyamala Navada, MD
myf1001-info@geron.com
650-473-7793
Backup
Judy Ho
myf1001-info@geron.com
650-473-7793
Time Frame
Start Date: 2022-05-04
Estimated Completion Date: 2028-08
Participants
Target number of participants: 51
Treatments
Experimental: Part 1: Imetelstat sodium + Ruxolitinib
Participants who have received ruxolitinib orally (PO) as part of standard of care (SOC) for at least 12 weeks prior to Screening will be enrolled. After enrollment, participants will initiate imetelstat sodium therapy. Dose levels of imetelstat sodium may include 4.7, 6, 7.5, 9.4mg, until a RP2D is established.
Experimental: Part 2: Imetelstat sodium + Ruxolitinib or other JAK inhibitor
Cohort A: Janus Kinase (JAK) inhibitor naive participants will receive initial treatment with ruxolitinib on study for at least 12 weeks, including 4 consecutive weeks at a stable dose, prior to the addition of imetelstat sodium. Participants can begin imetelstat sodium treatment after sponsor review and approval and meet the following requirements: platelet value is ≥100 x 109/L for two consecutive measurements, at least 1 week apart, and the participant does not meet criteria for dose delay.~Cohort B: Participants will receive treatment with ruxolitinib or other JAK inhibitor for 12 weeks (maximum 48 weeks) with at least 4 consecutive weeks at a stable dose prior to enrollment and will start combination treatment with imetelstat on study.
Related Therapeutic Areas
Sponsors
Leads: Geron Corporation

This content was sourced from clinicaltrials.gov