A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

  • STATUS
    Recruiting
Updated on 22 January 2021
myelofibrosis
myeloproliferative disorder
myeloproliferative syndromes
myeloproliferative/myelodysplastic disorders
myeloproliferative disorders

Summary

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

Details
Condition Myelofibrosis, Blood Cancer
Clinical Study IdentifierTX261983
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of PMF, PPV-MF, or PET-MF
DIPSS risk category of intermediate-1, intermediate-2, or high
Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit
Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form
Participants with an ECOG performance status score of 0, 1, or 2
Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF
Life expectancy of at least 24 weeks
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Prior use of any JAK inhibitor
Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib)
Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
Recent history of inadequate bone marrow reserve
Inadequate liver and renal function at screening
Active bacterial, fungal, parasitic, or viral infection that requires therapy
Active HBV or HCV infection that requires treatment or at risk for HBV reactivation
Known HIV infection
Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol
Active invasive malignancy over the previous 2 years
Splenic irradiation within 6 months before receiving the first dose of study drug
Concurrent use of any prohibited medications
Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study
Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy
Currently breastfeeding or pregnant
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
History of Grade 3 or 4 irAEs from prior immunotherapy
Receipt of any live vaccine within 30 days of the first dose of study drug
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note