A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis

Part of paid clinical trials in Duarte, California.

Sponsor
Geron Corporation
Study ID
NCT05371964
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imetelstat sodium — DRUG
    Imetelstat sodium will be administered as intravenous (IV) every 28 days.
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered, orally (PO), twice daily (BID) in cohort B as the standard of care per local prescribing guidelines.

Study Details

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 preliminary clinical activity of the R2PD of imetelstat sodium in combination with ruxolitinib in participants with MF in Part 2.

Key Dates

Start date
May 4, 2022
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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, 9.4 mg/kg, until a RP2D is established.
  • Experimental: Part 2: Imetelstat sodium + Ruxolitinib
    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 ≥75 x 10\^9/L for two consecutive measurements, at least 1 week apart, and the participant does not meet criteria for dose delay. Note that the study will no longer recruit participants into Cohort A. Cohort B: Participants will receive treatment with ruxolitinib for 12 weeks with at least 4 consecutive weeks at a stable dose prior to enrollment and will start combination treatment with imetelstat on study.

Primary Outcome Measure

Part 1: Incidence, Type, and Severity of Adverse Events, Including Dose-limiting Toxicity (DLT) During the DLT Observation Period and/or Study Treatment [ Time Frame: 28 days after first dose ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of HopeIrvineCalifornia92618-
University of MiamiCoral GablesFlorida33146-
H. Lee Moffitt Cancer Center and Research Institute, Inc.TampaFlorida33612-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Texas OncologyDenisonTexas75020-
Texas OncologyTylerTexas75702-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACity of Hope· Irvine, CAUniversity of Miami· Coral Gables, FLH. Lee Moffitt Cancer Center and Research Institute, Inc.· Tampa, FLIcahn School of Medicine at Mount Sinai· New York, NYTexas Oncology· Denison, TX

Related Studies