A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
ADAGIO
A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma
1 other identifier
interventional
109
5 countries
27
Brief Summary
This Phase 2b study aims to evaluate the efficacy and safety of adavosertib, an inhibitor of the tyrosine kinase WEE1, in subjects with recurrent or persistent uterine serous carcinoma (USC) who have previously received at least 1 prior platinum-based chemotherapy regimen for the management of USC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2020
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedAugust 14, 2023
August 1, 2023
1.5 years
September 22, 2020
May 8, 2023
August 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for target lesions (TLs) and assessed by computed tomography (CT) or magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
up to 75 weeks
Secondary Outcomes (9)
Duration of Response (DoR)
up to 75 weeks
Depth of Response
Up to 75 weeks
Progression Free Survival (PFS)
Up to 75 weeks
Progression Free Survival Rate at 6 Months (PFS6)
Up to 6 months
Overall Survival (OS)
Up to 75 weeks
- +4 more secondary outcomes
Study Arms (1)
Adavosertib
EXPERIMENTALSubjects will receive adavosertib 300 mg administered orally, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
Interventions
The subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
Eligibility Criteria
You may qualify if:
- Subjects must be aged ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas are not eligible.
- Evidence of measurable disease as per RECIST v1.1.
- At least 1 prior platinum-based chemotherapy regimen for the management of USC. Prior receipt of immune checkpoint inhibitors, vascular endothelial growth factor (VEGF) inhibitors and human epidermal growth factor receptor 2 (HER2) targeted therapy is allowed. There is no restriction on the number of prior lines of systemic therapy.
- Eastern Cooperative Oncology Group performance (ECOG) status 0-1.
- Life expectancy ≥ 12 weeks.
- Subjects must have normal organ and marrow function at baseline, within 7 days prior to study drug administration.
- Consent to submit and provide a mandatory Formalin-fixed paraffin-embedded tumor sample for central testing.
- Female subjects who are not of childbearing potential and women of childbearing potential who agree to use adequate contraceptive measures.
You may not qualify if:
- Any underlying medical condition and uncontrolled intercurrent illness that would impair the ability of the subject to receive study treatment, as judged by the investigator.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment.
- Unable to swallow oral medications.
- Spinal cord compression or metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
- Subjects with current signs or symptoms of bowel obstruction, including sub-occlusive disease, related to underlying disease.
- Any of the following cardiac diseases currently or within the last 6 months:
- Unstable angina pectoris
- Acute myocardial infarction
- Congestive heart failure
- Conduction abnormality not controlled with pacemaker or medication
- Significant ventricular or supraventricular arrhythmias
- History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected.
- a) Resting corrected QTc interval using the Fridericia formula (QTcF) \> 480 msec, or b) congenital long QT syndrome.
- Immunocompromised subjects.
- Subjects with known active hepatitis (ie, hepatitis B or C).
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (27)
Research Site
Burbank, California, 91505, United States
Research Site
Duarte, California, 91010, United States
Research Site
La Jolla, California, 92093, United States
Research Site
West Hollywood, California, 90048, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Covington, Louisiana, 70433, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
New Brunswick, New Jersey, 08903, United States
Research Site
New York, New York, 10065, United States
Research Site
The Bronx, New York, 10467, United States
Research Site
Spokane, Washington, 99202, United States
Research Site
Vancouver, Washington, 98684, United States
Research Site
Toronto, M5G 2M9, Canada
Research Site
Dijon, 21079, France
Research Site
Marseille, 13273, France
Research Site
Nice, 6189, France
Research Site
Pierre-Bénite, 69495, France
Research Site
Saint-Herblain, 44805, France
Research Site
Milan, 20141, Italy
Research Site
Napoli, 80131, Italy
Research Site
Roma, 00168, Italy
Research Site
A Coruña, 15009, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Pozuelo de Alarcón, 28223, Spain
Related Publications (2)
Liu JF, Colombo N, Oza AM, Frenel JS, Corr BR, Rubinstein MM, Nevadunsky NS, Lheureux S, Gaba L, Gonzalez Cortijo L, Salutari V, You B, Chiang S, O'Connor MJ, Oplustil O'Connor L, Meulendijks D, Khatun M, Ghiorghiu D, Oaknin A. ADAGIO: A Phase IIb, Open-Label, Single-Arm, Multicenter Study Assessing the Efficacy and Safety of Adavosertib (AZD1775) as Treatment for Recurrent or Persistent Uterine Serous Carcinoma. J Clin Oncol. 2025 Sep 10;43(26):2897-2907. doi: 10.1200/JCO-24-01606. Epub 2025 Apr 22.
PMID: 40262070DERIVEDLiu J, Oza AM, Colombo N, Oaknin A. ADAGIO: a phase IIb international study of the Wee1 inhibitor adavosertib in women with recurrent or persistent uterine serous carcinoma. Int J Gynecol Cancer. 2022 Jan;32(1):89-92. doi: 10.1136/ijgc-2021-003144. Epub 2021 Oct 29.
PMID: 34716177DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca Clinical Study Information Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce Liu, MD, MPH
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2020
First Posted
October 19, 2020
Study Start
November 30, 2020
Primary Completion
May 23, 2022
Study Completion
February 7, 2023
Last Updated
August 14, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.