Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or can carry out light work.
Select...
I am willing to have tissue samples taken before and during treatment.
Select...
My uterine cancer has come back or hasn't gone away and is a specific type called 'serous carcinoma'.
Select...
I have had one platinum-based chemotherapy for advanced uterine cancer.
Select...
I am 18 years old or older.
Select...
My uterine carcinosarcoma has recurred with specific features.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Progression-free survival
Secondary outcome measures
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 • NCT0301247785%
Nausea
79%
Fatigue
74%
Vomiting
50%
Diarrhea
41%
Constipation
35%
Neutrophil count decreased
32%
Anemia
29%
Anorexia
26%
Pain
24%
Dysgeusia
24%
Headache
24%
Peripheral sensory neuropathy
21%
Dyspnea
21%
Tinnitus
18%
Cough
18%
Platelet count decreased
15%
Insomnia
15%
Urinary tract infection
12%
Back pain
12%
Dehydration
9%
Edema limbs
9%
Dizziness
9%
Gastrointestinal disorders - Other
9%
Hot flashes
9%
Lymphedema
9%
Abdominal pain
9%
Aspartate aminotransferase increased
9%
Creatinine increased
9%
Weight gain
6%
Confusion
6%
Dyspepsia
6%
Thromboembolic event
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%
Breast pain
3%
Pneumonitis
3%
Alanine aminotransferase increased
3%
Alkaline phosphatase increased
3%
Sepsis
3%
Sinus pain
3%
Stomach pain
3%
Cognitive disturbance
3%
Anxiety
3%
Syncope
3%
Nervous system disorders - Other
3%
Pleural effusion
3%
Pain in extremity
3%
Depression
3%
Bruising
3%
Flatulence
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
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
4,265 Previous Clinical Trials
288,605,233 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,899 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My organs and bone marrow are functioning normally.I have not recently had chemotherapy, radiotherapy, or experimental treatments.I have brain metastases or another CNS condition.I am willing to have tissue samples taken before and during treatment.My uterine cancer has come back or hasn't gone away and is a specific type called 'serous carcinoma'.I am HIV-positive.I am currently taking herbal supplements.My tumor is MSI-high/MMR-deficient and I haven't had immune checkpoint inhibitors.I do not have any unmanaged ongoing illnesses.I have had one platinum-based chemotherapy for advanced uterine cancer.I have had other types of cancer besides the one I'm seeking treatment for.I am taking medication that is affected by CYP3A4.I have a heart condition.I am 18 years old or older.I have had recent surgery.I have previously received treatment with a cell cycle checkpoint inhibitor.My uterine carcinosarcoma has recurred with specific features.
Research Study Groups:
This trial has the following groups:- Group 1: Part C: AZD1775 in Uterine Serous with biopsiable disease
- Group 2: Part A: AZD1775
- Group 3: Part B: AZD1775 in Carcinosarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be able to join this experiment?
"That is correct. Based on the information available on clinicaltrials.gov, this trial is still looking for enrollees. The posting date was October 22nd, 2018 and the most recent update was July 5th, 2022. They have only found 1 of the 80 patients they need so far."
Answered by AI
Has the FDA given its stamp of approval to AZD1775?
"While Phase 2 trials don't have the same rigor as later stages, there is still some evidenceAZD1775 is safe. Our team at Power rates it a 2."
Answered by AI
Are participants being enrolled in this clinical trial at the present moment?
"The information available on clinicaltrials.gov does seem to imply that this study is still looking for candidates. According to the website, the trial was first posted on October 22nd, 2018 and updated as recently as July 5th, 2022. The goal is to have 80 people enrolled at a single site."
Answered by AI
What does the research say about AZD1775's effectiveness?
"Out of the 17 ongoing studies related to AZD1775, none are currently in Phase 3. The majority of these investigations taking place in Royal Oak, Michigan; however, there are 1671 total locations where research is being conducted."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger