Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

  • STATUS
    Recruiting
  • End date
    Sep 4, 2025
  • participants needed
    18
  • sponsor
    University of Chicago
Updated on 21 May 2021
anemia
myelofibrosis
chronic myelomonocytic leukemia
ruxolitinib
direct bilirubin
thrombocytopenia
conjugated bilirubin
polycythemia vera
essential thrombocythemia
thrombocytosis
polycythemia
myelodysplastic/myeloproliferative neoplasms

Summary

This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.

Description

This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. For the purposes of DLT assessment, subjects will be stratified into 2 cohorts- cohort A will include subjects with MDS and MDS/MPN; cohort B will include subjects with myelofibrosis. Dose escalation will proceed independently in each of these cohorts. Determination of MTD will thus also proceed independently within each cohort. Three dose levels of selumetinib are planned for evaluation. Dose escalation will follow a 3+3 study design. Patients will be enrolled sequentially and stratified according to disease type as outlined above. An increased dose level will only open to accrual once at least 3 patients have been treated at the lower dose, followed for the defined DLT observation period (28 days, see section 2.8 below), and the lower dose level has been deemed safe.

The 3+3 dose escalation algorithm will proceed as follows:

  1. If 0/3 patients develop a DLT at a dose level, escalate to the next dose level.
  2. If 1/3 patients develops a DLT at a dose level, enroll 3 additional patients at that dose level.
  3. At that dose level, if 1/6 patients develops a DLT, escalate to the next dose level.
  4. If 2/6 patients develop a DLT, that dose level will be determined to be too toxic.
  5. If 2-3/3 patients develop a DLT at a dose level, that dose level will be determined to be too toxic.
  6. Six patients will be treated at the MTD.
  7. If the study progresses to dose level 3 with 0/3 patients experiencing a DLT, an additional 3 patients will be enrolled at that dose level to gain additional information regarding toxicity.
  8. If a dose level is determined to be too toxic and the next lower dose level only included 3 patients, an additional 3 patients will be treated at the lower dose level to confirm tolerability.
  9. If no patients have a DLT reported at dose level 3, that will be defined as the MTD and the dose will not be escalated above that level.

Details
Condition Myelosclerosis with myeloid metaplasia, Chronic myeloid leukemia, Myelofibrosis, chronic myelogenous leukemia
Treatment Selumetinib, Azacitidine
Clinical Study IdentifierNCT03326310
SponsorUniversity of Chicago
Last Modified on21 May 2021

Eligibility

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