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Uterine CancerPhase 2NCT03668340

AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma

A Phase 2 study testing AZD1775 in people with Uterine Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is studying an investigational drug as a possible treatment for uterine cancer. The drug involved in this study is: -AZD1775 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cancer
What is being tested?
AZD1775
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
22 Oct 2018to 1 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants in Parts A and C must have histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma. For the purposes of this study, uterine carcinomas (with the exception of carcinosarcomas) that have any component that is considered serous will be considered a uterine serous carcinoma.
  • Participants in Part B must have histologically or cytologically confirmed recurrent uterine carcinosarcoma. Additionally, the following features must also be present:
  • Presence of a p53 alteration (by either IHC or next generation sequencing)
  • Metastatic or extra-uterine component must be confirmed on pathology to be from the carcinoma component of the disease
  • Patients without confirmation that the metastatic or extrauterine component of disease is of carcinoma histology may be considered after discussion with the PI
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST 1.1 criteria. See Section 11 for the evaluation of measurable disease.
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  • Participants must have had one prior platinum-based chemotherapy regimen for management of advanced or metastatic uterine serous carcinoma or uterine carcinosarcoma. Chemotherapy administered only in conjunction with primary RT as a radiosensitizer should not count as a systemic regimen. There is no restriction on the number of prior lines of therapy a participant may have previously received.
  • Age 18 years or older.
  • ECOG performance status 0 or 1 (see Appendix A)
  • Participants must have normal organ and marrow function as defined below:
  • absolute neutrophil count ≥1,500/mcL
  • hemoglobin ≥9 g/dL
  • platelets ≥100,000/mcL
  • total bilirubin ≤ upper limit of normal (ULN) or ≤1.5x ULN in patients with liver metastases or well-documented Gilbert's Syndrome.
  • AST(SGOT)/ALT(SGPT) ≤3 × ULN or ≤5 × ULN in patients with liver metastases
  • creatinine ≤1.5 × ULN OR
  • creatinine clearance ≥45 mL/min/1.73 m2 as calculated by the Cockroft-Gault method for participants with creatinine levels above institutional normal.
  • Willingness to release archival tissue for research purposes.
  • Participants in Part C must have biopsiable disease (in a lesion that is not being utilized as the target lesion for RECIST assessment) and be willing to undergo pre- and on-treatment biopsies. Participants in Part B with biopsiable disease must be willing to undergo pre- and on-treatment biopsies.
  • The effects of AZD1775 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from 2 weeks prior to study entry and for 1 month after study drug discontinuation. Please see Appendix C for "Definition Women of Childbearing Potential and Acceptable Contraceptive Methods." Patients of child-bearing potential should not be breastfeeding, and must have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants who have had chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of AZD1775, or those who have not recovered to Grade 1 from adverse events (excluding alopecia or anorexia) due to agents administered more than 3 weeks earlier. Participants may not have had hormonal therapy within 2 weeks of the first dose of AZD1775.
  • Participants who are receiving any other investigational agents.
  • Participants who have MSI-high or MMR-deficient tumors will not be eligible unless they have already received prior therapy with pembrolizumab or another PD1/PD-L1 immune checkpoint inhibitor or are deemed not to be a candidate for immune checkpoint therapy.
  • Participants with known brain metastases or other CNS disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with treated brain metastases that have no evidence of progression or hemorrhage for at least 2 weeks after treatment will be allowed on study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775.
  • Participants may not have had prior receipt of a cell cycle checkpoint inhibitor (e.g., Chek1, Wee1, or ATR inhibition)
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  • Participants receiving any medications or substances that are sensitive CYP3A4 substrates or are CYP3A4 substrates with a narrow therapeutic index, or which are moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued two weeks prior to Day 1 of dosing and withheld through the study until 2 weeks after the last dose of study drug. Co-administration of aprepitant or fosaprepitant during this study is prohibited.
  • Transporter studies (in vitro) have shown that AZD1775 is an inhibitor of breast cancer resistance protein (BRCP). Please see Appendix B for additional details regarding prohibited drugs and drugs to be used with caution, including drugs affected by CYP3A4 or BRCP. Because the lists of these agents are constantly changing, it is important to also regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information.
  • Participants must not have undergone major surgical procedures within 28 days of beginning study treatment or minor surgical procedures within 7 days of beginning study treatment. Port-a-cath placement will be allowed within a 7 day window of starting study treatment.
  • Participants must be able to swallow oral medication and may not have a percutaneous endoscopic gastrostomy (PEG) tube, be receiving total parenteral nutrition (TPN), or be dependent on IV fluid support.
  • Participants with any of the following cardiac diseases currently or within the last 6 months as defined by the New York Heart Association (NYHA) ≥ Class 2 will not be eligible:
  • Unstable angina pectoris
  • Congestive heart failure
  • Acute myocardial infarction
  • Conduction abnormality not controlled with pacemaker or medication
  • Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
  • Participants with a mean resting corrected QT interval (QTc) ≥ 480msec at study entry, as calculated by the Frederica formula (QTcF) by institutional standards obtained from an electrocardiogram (ECG) or congenital long QT syndrome. (Note: if one ECG demonstrates a QTcF >480 msec, then a mean QTcF of ≤ 480 msec obtained from 3 ECGs 2-5 minutes apart is required at study entry.
  • Participants with any concomitant or prior invasive malignancies are ineligible with the following exceptions:
  • Treated limited-stage basal cell or squamous cell carcinoma of the skin
  • Carcinoma in situ of the breast or cervix
  • Prior cancer treated with curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because AZD1775 is an agent with an unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD1775, breastfeeding should be discontinued if the mother is treated with AZD1775.
  • Known HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions of antiretroviral medications with AZD1775 and the potential for an increased risk of lethal infections for these participants when treated with marrow-suppressive therapy.
  • Because the composition, PK, and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, St. John's wort, kava, ephedra [m huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, and ginseng). Participants should stop herbal medications at least 7 days prior to first dose of AZD1775.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase 2 Study of the Wee1 Inhibitor AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma

This research study is studying an investigational drug as a possible treatment for uterine cancer.

The drug involved in this study is:

-AZD1775

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved AZD1775 as a treatment for any disease.

The "investigational drug" AZD1775 is being given alone to patients with this type of cancer. AZD1775 is also being studied in lung cancer, ovarian cancer, and other solid tumors throughout the world. AZD1775 blocks the activity of Wee1, a protein that helps to regulate how cells divide and grow. Certain cancer cells may be more vulnerable to having this process blocked. This study is being done to assess the safety and effectiveness of AZD1775 to learn if AZD1775 works in treating this type of cancer.

Conditions
Uterine Cancer
Being tested
AZD1775
Keywords
Uterine Cancer
Medical subject headings
Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1775Drug

    AZD1775 blocks the activity of Wee1, a protein that helps to regulate how cells divide and grow. Certain cancer cells may be more vulnerable to having this process blocked

Study groups in NCT03668340
Study groupRoleWhat they receive
Part A: AZD1775Experimental-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Receives: Drug: AZD1775
Part B: AZD1775 in CarcinosarcomaExperimental-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Receives: Drug: AZD1775
Part C: AZD1775 in Uterine Serous with biopsiable diseaseExperimental-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Receives: Drug: AZD1775

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]

    Measured: 2 years

  2. Progression-free survival

    Measured by the rate of progression-free survival at 6 months (PFS6) using RECIST v.1.1.

    Measured: 6 months

Secondary outcomes (3)

  1. Clinical benefit rate

    Clinical benefit rate is defined as response rate plus stable disease x 6 months.

    Measured: 2 years

  2. Duration of Response

    The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

    Measured: 2 years

  3. Assess the toxicities of AZD1775 in women with recurrent or persistent uterine serous carcinoma or uterine carcinosarcoma using CTCAE v4

    Toxicities will be assessed using CTCAE v4.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start22 Oct 2018
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668340
Sponsor's protocol ID
18-316
Status last verified
Sep 2026
First submitted
11 Sep 2018
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu JF, Xiong N, Campos SM, Wright AA, Krasner C, Schumer S, Horowitz N, Veneris J, Tayob N, Morrissey S, West G, Quinn R, Matulonis UA, Konstantinopoulos PA. Phase II Study of the WEE1 Inhibitor Adavosertib in Recurrent Uterine Serous Carcinoma. J Clin Oncol. 2021 May 10;39(14):1531-1539. doi: 10.1200/JCO.20.03167. Epub 2021 Mar 11.

    PubMed 33705205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1775 in people with Uterine Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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