Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-11 @ 4:26 PM
Study NCT ID:
NCT02666950
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2016-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase 2 Study of WEE1 Inhibition With AZD1775 Alone or Combined With Cytarabine in Patients With Advanced Acute Myeloid Leukemia and Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving WEE1 inhibitor AZD1775 works better with or without cytarabine in treating patients with advanced acute myeloid leukemia or myelodysplastic syndrome.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the clinical efficacy of AZD1775 (WEE1 inhibitor AZD1775) in combination with AraC (cytarabine) in patients with newly diagnosed acute myeloid leukemia (AML) by assessing complete response (complete remission \[CR\] plus CR with incomplete blood count recovery \[CRi\]) rates.
II. To estimate the clinical efficacy of AZD1775 alone or in combination with AraC in patients with relapsed/refractory AML and hypomethylating agent failure myelodysplastic syndrome (MDS) by assessing complete response (CR plus CRi) rates.
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of AZD1775 alone or combined with AraC in the study population.
II. To estimate additional measures of clinical benefit (i.e. hematological improvements, transfusion requirements).
III. To measure the duration of response of AZD1775 alone or combined with AraC.
IV. To measure time to response of AZD1775 alone or combined with AraC. V. To measure time to progression of AZD1775 alone or combined with AraC. VI. To measure overall survival of AZD1775 alone or combined with AraC. VII. To measure time to AML (for MDS subjects) of AZD1775 alone or combined with AraC.
TERTIARY OBJECTIVES:
I. To determine the pharmacokinetics (PK) of AZD1775 alone or combined with AraC in the study population.
II. To conduct correlative research studies characterizing underlying molecular events and solidifying putative mechanism of action in vivo and to identify potential pharmacodynamic/biomarkers of response to AZD1775 alone or combined with AraC.
III. To evaluate quality of life (QOL) and patient-reported symptoms in subjects treated with AZD1775 alone or combined with AraC.
OUTLINE: Elderly newly diagnosed patients are assigned to arm A.
ARM A (ELDERLY NEWLY DIAGNOSED PATIENTS): Patients receive cytarabine subcutaneously (SC) twice daily (BID) on days 1-5 and 8-12 and WEE inhibitor AZD1775 orally (PO) daily on days 1-5 and 8-12.
Patients are randomized to 1 of 2 treatment arms.
ARM B: Patients receive cytarabine and WEE1 inhibitor AZD1775 as in Arm A.
ARM C: Patients receive WEE inhibitor AZD1775 PO daily on days 1-5, 8-12, 15-19, and 22-26.
In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
I. To estimate the clinical efficacy of AZD1775 (WEE1 inhibitor AZD1775) in combination with AraC (cytarabine) in patients with newly diagnosed acute myeloid leukemia (AML) by assessing complete response (complete remission \[CR\] plus CR with incomplete blood count recovery \[CRi\]) rates.
II. To estimate the clinical efficacy of AZD1775 alone or in combination with AraC in patients with relapsed/refractory AML and hypomethylating agent failure myelodysplastic syndrome (MDS) by assessing complete response (CR plus CRi) rates.
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of AZD1775 alone or combined with AraC in the study population.
II. To estimate additional measures of clinical benefit (i.e. hematological improvements, transfusion requirements).
III. To measure the duration of response of AZD1775 alone or combined with AraC.
IV. To measure time to response of AZD1775 alone or combined with AraC. V. To measure time to progression of AZD1775 alone or combined with AraC. VI. To measure overall survival of AZD1775 alone or combined with AraC. VII. To measure time to AML (for MDS subjects) of AZD1775 alone or combined with AraC.
TERTIARY OBJECTIVES:
I. To determine the pharmacokinetics (PK) of AZD1775 alone or combined with AraC in the study population.
II. To conduct correlative research studies characterizing underlying molecular events and solidifying putative mechanism of action in vivo and to identify potential pharmacodynamic/biomarkers of response to AZD1775 alone or combined with AraC.
III. To evaluate quality of life (QOL) and patient-reported symptoms in subjects treated with AZD1775 alone or combined with AraC.
OUTLINE: Elderly newly diagnosed patients are assigned to arm A.
ARM A (ELDERLY NEWLY DIAGNOSED PATIENTS): Patients receive cytarabine subcutaneously (SC) twice daily (BID) on days 1-5 and 8-12 and WEE inhibitor AZD1775 orally (PO) daily on days 1-5 and 8-12.
Patients are randomized to 1 of 2 treatment arms.
ARM B: Patients receive cytarabine and WEE1 inhibitor AZD1775 as in Arm A.
ARM C: Patients receive WEE inhibitor AZD1775 PO daily on days 1-5, 8-12, 15-19, and 22-26.
In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-02136 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC1488 | OTHER | Mayo Clinic in Arizona | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |