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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

John Mei
650-542-0136
jmei@kartosthera.com


Timothy Sbardellati
tsbardellati@kartosthera.com


Study Location:

University Hospital of Wales
Cardiff


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An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Recruiting

Open to: All Genders

Age: 18 Years - N/A

Medical Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2019

Dec 2023

Interventional

Intervention Type : Drug
Intervention Description : KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.

Intervention Arm Group : Part A - Arm 1;Part A - Arm 2;Part A - Arm 3;Part B - Arm 1;Part B - Arm 2;Part B - Arm 3

Intervention Type : Drug
Intervention Description : Cytarabine is an anti-cancer chemotherapy drug taken via injection.

Intervention Arm Group : Part A - Arm 1

Intervention Type : Drug
Intervention Description : Decitabine is an anti-cancer chemotherapy drug taken via injection.

Intervention Arm Group : Part A - Arm 2;Part A - Arm 3

You can take part if:


Key Inclusion Criteria: - Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN - Part B:Patients with relapsed or refractory AML secondary to MPN (myelofibrosis [MF], polycythemia vera [PV], or essential thrombocythemia [ET]); patients may have been treated with ≥1 prior lines of therapy for their AML secondary to MPN. - Adequate hepatic and renal function - Appropriate prior treatment with an FLT3 or IDH1/2 inhibitor where applicable Key Exclusion Criteria: - Patients who are TP53 mutation positive - Prior treatment with an MDM2 antagonist therapy - Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for Part A) . - Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A) . - Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A) - Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B) - Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study - Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study. - Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis - Patients who have had major surgery within 28 days prior to the first treatment with KRT-232 - Women who are pregnant or breastfeeding




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital of Wales
    Cardiff
  • The Royal Marsden Hospital
    London
    SW3 6JJ


The study is sponsored by Kartos Therapeutics, Inc. .



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for Trial ID: NCT04113616

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