Testing the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Treatment
Phase 1 study for recurrent endometrial and ovarian cancer
Clinicaltrials.gov identifier:NCT05950464
Study Contact Information:
For additional information, please contact:
Principal Investigator: Fiona Simpkins, NRG Oncology
[email protected]
or Nurse Support Contact: Perelmangyn/onc/[email protected]
About the Study
This study is for patients with clear cell or endometrioid ovarian or which has returned or spread after other treatments. Patients with high-grade serous ovarian cancer are also allowed to enroll in Part I of this study. This Phase I trial will test a new combination of two medications, M1774 and ZEN003694, that has been shown to significantly kill cancer cells and tumors in animal studies.
This Study is Open To:
This study is open to people:
- who have clear cell ovarian or or endometrioid ovarian or that has returned or spread after other treatments
- with high-grade serous ovarian carcinoma may join group 1 of this study
- 18 years of age or older
- 1-3 prior chemotherapies
This Study is NOT Open To:
This study is not open to people:
- who are receiving any other investigational agents
- who have received prior ATR, , CHK, BET, EZH2, and/or PI3K inhibitors
- have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or M1774 used in the study
- taking proton pump inhibitor. Proton pump inhibitors must be discontinued 7 days prior to initiating the trial.
- with corrected QT or family history of long QT syndrome (a heart rhythm disorder)
- with known hereditary diseases characterized by genetic defects of repair mechanisms
- pregnant or breastfeeding. Patients who discontinue breastfeeding are eligible for enrollment and may not resume breastfeeding until 1 month off treatment.
- receiving any medications or substances that are Factor Xa inhibitors ( a type of blood thinner) are discouraged, given concerns for low platelet counts and Factor IIa inhibitors
- with serious gastrointestinal bleeding within the past 3 months, nausea and vomiting, uncontrolled diarrhea, significant small bowel resection or gastric bypass surgery
What the Study Involves
The study is divided into two groups.
Group I: different drug combination doses are tested to identify the safe dose for patients.
- Patients receive the study drug, M1774 orally once daily, either on days 2-14 of cycle 1 and days 1-14 of subsequent cycles or
- Patients receive the study drug, M1774 orally once daily on days 1-14 of each cycle, and they study drug, ZEN-3694 orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable .
- Patients also undergo collection of blood samples on study and X-ray, computed tomography (CT), or magnetic resonance imaging () throughout the trial.
Group 2: patients will be evaluated on the safety of the treatment, and also the activity of the treatment in two groups of patients: those with and without a mutation in the gene ARID1A.
- Patients in group 2 also undergo biopsies during screening and on-study, and X-ray, CT, or , and collection of blood samples throughout the trial.
After study completion, patients are followed every 3 months for 2 years and then every 6 months for 3 years, or until the study has ended.
The ultimate goal of this study is to identify a new treatment for patients with hard-to-treat ovarian and endometrial cancers.
Study Contact Information:
For additional information, please contact:
Principal Investigator: Fiona Simpkins, NRG Oncology
[email protected]
or Nurse Support Contact: Perelmangyn/onc/[email protected]
Locations:
Iowa
City: Iowa City RECRUITING
Facility: University of Iowa/Holden Comprehensive Cancer Center
Contact Info:
800-237-1225
David P. Bender
Illinois
City: Chicago RECRUITING
Facility: University of Chicago Comprehensive Cancer Center
Contact Info:
[email protected]
773-702-8222
Katherine C. Kurnit
New Mexico
City: Albuquerque RECRUITING
Facility: University of New Mexico Cancer Center
Contact Info:
[email protected]
505-925-0348
Carolyn Y. Muller
Ohio
City: Cleveland RECRUITING
Facility: Cleveland Clinic Foundation
Contact Info:
[email protected]
866-223-8100
Peter G. Rose
City: Columbus RECRUITING
Facility: Ohio State University Comprehensive Cancer Center
Contact Info:
[email protected]
800-293-5066
John L. Hays
Oklahoma
City: Oklahoma City RECRUITING
Facility: University of Oklahoma Health Sciences Center
Contact Info:
[email protected]
405-271-8777
Lauren E. Dockery
Pennsylvania
City: Philadelphia RECRUITING
Facility: NRG Oncology
Contact Info:
[email protected]
Fiona Simpkins
City: Philadelphia RECRUITING
Facility: University of Pennsylvania/Abramson Cancer Center
Contact Info:
[email protected]
215-349-8245
Fiona Simpkins
City: Philadelphia RECRUITING
Facility: Thomas Jefferson University Hospital
Contact Info:
[email protected]
215-600-9151
Mitchell I. Edelson
Rhode Island
City: Providence RECRUITING
Facility: Women and Infants Hospital
Contact Info:
401-274-1122
Cara A. Mathews
Wisconsin
City: Milwaukee RECRUITING
Facility: Medical College of Wisconsin
Contact Info:
414-805-3666
William H. Bradley
Treatment
Phase 1 study for recurrent endometrial and ovarian cancer
Clinicaltrials.gov identifier:NCT05950464
Study Contact Information:
For additional information, please contact:
Principal Investigator: Fiona Simpkins, NRG Oncology
[email protected]
or Nurse Support Contact: Perelmangyn/onc/[email protected]