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Small Molecule Inhibitor

AZD1775 for Uterine Cancer

Phase 2
Waitlist Available
Led By Joyce Liu, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 or 1
Participants with biopsiable disease must be willing to undergo pre- and on-treatment biopsies
Must not have
Recent chemotherapy, radiotherapy, or investigational therapy
Known brain metastases or other CNS disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing AZD1775 to see if it can help treat patients with uterine cancer.

Who is the study for?
This trial is for women aged 18+ with recurrent or persistent uterine serous carcinoma or carcinosarcoma, who've had one platinum-based chemo treatment. They must have measurable disease, normal organ/marrow function, and not be pregnant or breastfeeding. Participants need to agree to use contraception and can't join if they've recently had certain treatments, other cancers (with exceptions), severe heart conditions, uncontrolled illnesses, or are HIV-positive.
What is being tested?
The study tests AZD1775 as a potential treatment for uterine cancer. It's an investigational drug given orally. The trial will assess its effectiveness in patients with specific genetic alterations (p53) and those who have previously undergone chemotherapy but whose cancer has returned.
What are the potential side effects?
While the exact side effects of AZD1775 aren't listed here, similar drugs may cause nausea, fatigue, blood count changes leading to infection risk increase or bleeding problems; liver issues; allergic reactions; heart rhythm problems; and could potentially harm an unborn child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am willing to have tissue samples taken before and during treatment.
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My uterine cancer has come back or hasn't gone away and is a specific type called 'serous carcinoma'.
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I have had one platinum-based chemotherapy for advanced uterine cancer.
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I am 18 years old or older.
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My uterine carcinosarcoma has recurred with specific features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not recently had chemotherapy, radiotherapy, or experimental treatments.
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I have brain metastases or another CNS condition.
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I am HIV-positive.
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I am currently taking herbal supplements.
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My tumor is MSI-high/MMR-deficient and I haven't had immune checkpoint inhibitors.
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I do not have any unmanaged ongoing illnesses.
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I have had other types of cancer besides the one I'm seeking treatment for.
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I have a heart condition.
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I have previously received treatment with a cell cycle checkpoint inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate
Progression-free survival
Secondary study objectives
Assess the toxicities of AZD1775 in women with recurrent or persistent uterine serous carcinoma or uterine carcinosarcoma using CTCAE v4
Clinical benefit rate
Duration of Response

Side effects data

From 2020 Phase 2 trial • 34 Patients • NCT03012477
85%
Nausea
79%
Fatigue
74%
Vomiting
50%
Diarrhea
41%
Constipation
35%
Neutrophil count decreased
32%
Anemia
29%
Anorexia
26%
Pain
24%
Dysgeusia
24%
Peripheral sensory neuropathy
24%
Headache
21%
Dyspnea
21%
Tinnitus
18%
Cough
18%
Platelet count decreased
15%
Insomnia
15%
Urinary tract infection
12%
Back pain
12%
Dehydration
9%
Gastrointestinal disorders - Other
9%
Dizziness
9%
Edema limbs
9%
Hot flashes
9%
Lymphedema
9%
Abdominal pain
9%
Aspartate aminotransferase increased
9%
Creatinine increased
9%
Weight gain
6%
Confusion
6%
Thromboembolic event
6%
Dyspepsia
6%
Pruritus
6%
Rash acneiform
6%
Skin and subcutaneous tissue disorders - Other
6%
Alopecia
6%
Dry skin
6%
Weight loss
6%
Chest wall pain
6%
Myalgia
6%
Neck pain
3%
Syncope
3%
Cognitive disturbance
3%
Flatulence
3%
Nervous system disorders - Other
3%
Breast pain
3%
Alkaline phosphatase increased
3%
Stomach pain
3%
Alanine aminotransferase increased
3%
Depression
3%
Pneumonitis
3%
Sepsis
3%
Pain in extremity
3%
Bruising
3%
Pleural effusion
3%
Sinus pain
3%
Anxiety
3%
Rash maculo-papular
3%
Cardiac arrest
3%
Cardiac disorders - Other
3%
Sinus tachycardia
3%
Ear and labyrinth disorders - Other
3%
Arthralgia
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Hearing impaired
3%
Endocrine disorders - Other
3%
Hypothyroidism
3%
Flu like symptoms
3%
Irritability
3%
Localized edema
3%
Non-cardiac chest pain
3%
Allergic reaction
3%
Cardiac troponin T increased
3%
Investigations - Other
3%
Acidosis
3%
Hypocalcemia
3%
Hypomagnesemia
3%
Hyponatremia
3%
Muscle weakness upper limb
3%
Chronic kidney disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cisplatin + AZD1775

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: AZD1775 in Uterine Serous with biopsiable diseaseExperimental Treatment1 Intervention
-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Group II: Part B: AZD1775 in CarcinosarcomaExperimental Treatment1 Intervention
-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Group III: Part A: AZD1775Experimental Treatment1 Intervention
-AZD1775 will be taken by mouth daily on days 1 through 5 and days 8 through 12 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD1775
2015
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,388 Previous Clinical Trials
289,109,056 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,107 Previous Clinical Trials
357,079 Total Patients Enrolled
Joyce Liu, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Brigham & Women'S Hospital (Residency)

Media Library

AZD1775 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03668340 — Phase 2
Uterine Cancer Research Study Groups: Part C: AZD1775 in Uterine Serous with biopsiable disease, Part A: AZD1775, Part B: AZD1775 in Carcinosarcoma
Uterine Cancer Clinical Trial 2023: AZD1775 Highlights & Side Effects. Trial Name: NCT03668340 — Phase 2
AZD1775 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03668340 — Phase 2
~1 spots leftby Dec 2024
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