← Back to Search

Tyrosine Kinase Inhibitor

Adavosertib for Uterine Carcinoma (ADAGIO Trial)

Phase 2

Waitlist Available

Led By Joyce Liu, MD, MPH

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

ADAGIO Trial Summary

This trial will test if a new drug, adavosertib, is effective and safe for treating uterine serous carcinoma that has come back or persisted after previous treatment.

Eligible Conditions

Uterine Serous Carcinoma

ADAGIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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 (ORR)

Secondary outcome measures

Depth of Response

Disease Control Rate (DCR)

Duration of Response (DoR)

+6 more

Side effects data

From 2023 Phase 1 & 2 trial • 76 Patients • NCT02095132

80%

Lymphocyte count decreased

80%

Fatigue

80%

Hypoalbuminemia

80%

White blood cell decreased

80%

Vomiting

70%

Anemia

70%

Diarrhea

70%

Abdominal pain

70%

Nausea

60%

Anorexia

50%

Sinus tachycardia

50%

Cough

50%

Fever

50%

Pleural effusion

40%

Anxiety

40%

Neutrophil count decreased

40%

Aspartate aminotransferase increased

40%

Dyspnea

40%

Headache

40%

Platelet count decreased

30%

Insomnia

30%

Hypomagnesemia

30%

Alopecia

30%

Constipation

30%

Hypermagnesemia

30%

Pain

30%

Pain in extremity

30%

Dizziness

30%

Hypertension

30%

Dehydration

30%

Hypocalcemia

30%

Weight loss

20%

Allergic rhinitis

20%

Hyponatremia

20%

Alanine aminotransferase increased

20%

Hematuria

20%

Wound infection

20%

Atelectasis

20%

Gait disturbance

20%

Hyperkalemia

20%

Hypophosphatemia

20%

Hypokalemia

20%

Myalgia

20%

Nasal congestion

20%

Osteoporosis

20%

Productive cough

20%

Dry mouth

20%

Hypotension

20%

Peripheral sensory neuropathy

10%

Investigations - Other, ELEVATED LDH

10%

Lymphedema

10%

Muscle weakness upper limb

10%

Photophobia

10%

Pulmonary edema

10%

Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION

10%

Skin and subcutaneous tissue disorders - Other, SMEGMA

10%

Lethargy

10%

Infections and infestations - Other, Retropharyngeal infection

10%

Tumor pain

10%

Alkalosis

10%

Bruising

10%

Eye disorders - Other, Visual disturbance

10%

Localized edema

10%

Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY

10%

Sinus bradycardia

10%

Generalized muscle weakness

10%

Muscle weakness lower limb

10%

Urine output decreased

10%

Chest wall pain

10%

Malaise

10%

Skin ulceration

10%

Hypothyroidism

10%

Acute kidney injury

10%

Hyperglycemia

10%

Hypoxia

10%

Non-cardiac chest pain

10%

Back pain

10%

Blood bilirubin increased

10%

Blurred vision

10%

Chills

10%

Dyspepsia

10%

Dysphagia

10%

Fecal incontinence

10%

Gastritis

10%

Hyperhidrosis

10%

Hypernatremia

10%

Hypertriglyceridemia

10%

Infections and infestations - Other, C. DIFF INFECTION

10%

Infections and infestations - Other, E COLI

10%

Infections and infestations - Other, E. COLI

10%

Investigations - Other, BUN increased

10%

Investigations - Other, elevated LDH

10%

Lipase increased

10%

Metabolism and nutrition disorders - Other, CACHEXIA

10%

Mucositis oral

10%

Oculomotor nerve disorder

10%

Paresthesia

10%

Proteinuria

10%

Respiratory, thoracic and mediastinal disorders - Other,

10%

Respiratory, thoracic and mediastinal disorders - Other, TACHYPNEA

10%

Scoliosis

10%

Skin hypopigmentation

10%

Surgical and medical procedures - Other, G-tube placement

10%

Tinnitus

10%

Urinary retention

10%

Skin and subcutaneous tissue disorders - Other, TUMOR BLEEDING

10%

Urinary tract obstruction

10%

Alkaline phosphatase increased

10%

Bone pain

10%

Creatinine increased

10%

Dysgeusia

10%

Electrocardiogram QT corrected interval prolonged

10%

Investigations - Other, VIT D DEFICIENCY

10%

Hearing impaired

10%

Investigations - Other, bicarbonate serum low

10%

Neck pain

10%

Sore throat

100%

80%

60%

40%

20%

Study treatment Arm

Part D, Rhabdomyosarcoma

Part A, Dose Level 1

Part A, Dose Level 2

Part A, Dose Level 3

Part A, Dose Level 4

Part A, Dose Level 5

Part A, PK Expansion

Part B, Neuroblastoma

Part C, Medulloblastoma/CNS PNET

ADAGIO Trial Design

1Treatment groups

Experimental Treatment

Group I: AdavosertibExperimental Treatment1 Intervention

Subjects 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adavosertib

2015

Completed Phase 2

~570

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,717 Total Patients Enrolled

AstraZenecaLead Sponsor

4,265 Previous Clinical Trials

288,605,173 Total Patients Enrolled

Joyce Liu, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

25 Total Patients Enrolled

1 Trials studying Uterine Carcinoma

25 Patients Enrolled for Uterine Carcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a person is older than 20, do they still qualify for this research project?

"The age limit for this clinical trial is 18-130."

Answered by AI

Who is eligible to participate in this experiment?

"This clinical trial is looking for 109 people with cystadenocarcinoma, serous between the ages of 18 and 130. Most notably, candidates must meet the following criteria: -Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas are not eligible., -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.,"

Answered by AI

Are there any ongoing research projects with Adavosertib?

"Adavosertib was first studied in 2013 at University of Alabama at Birmingham Cancer Center. Since the inception of this research, 23 studies have been completed with data suggesting efficacy. There are 17 clinical trials that are still recruiting patients; many of these locations are based in Rochester, Minnesota."

Answered by AI

How many study participants are there in this trial?

"Unfortunately, this study is not presently enrolling any more patients. The trial was first posted on 11/30/2020 and the latest update was on 10/17/2022. However, if you are looking for other studies, there are 2586 trials actively recruiting participants with cystadenocarcinoma serous and 17 studies for Adavosertib that still have open enrollment."

Answered by AI

Has Adavosertib undergone the FDA's stamp of approval?

"While there is some evidence to support Adavosertib's safety, it only received a 2 because there are no efficacy data at this stage of the clinical trial process."

Answered by AI

In how many different places is this trial being run today?

"To make participation more convenient for patients, this study is being conducted at 23 sites. Some of these locations include Rochester and Vancouver; however, there are also 20 other recruitment centres."

Answered by AI

Is this research opportunity still available to new volunteers?

"This study is not recruiting new patients at this time, as stated on clinicaltrials.gov. This specific trial was first posted on November 30th 2020 and has not seen updates since October 17th 2022. However, there are 2603 other trials that are actively recruiting individuals for participation."

Answered by AI

Recent research and studies

International Journal of Gynecologic CancerJournal

ADAGIO: A Phase Iib International Study of the Wee1 Inhibitor Adavosertib in Women with Recurrent or Persistent Uterine Serous Carcinoma

Liu, Joyce, Amit M Oza, Nicoletta Colombo, and Ana Oaknin. 2021. “ADAGIO: A Phase Iib International Study of the Wee1 Inhibitor Adavosertib in Women with Recurrent or Persistent Uterine Serous Carcinoma”. International Journal of Gynecologic Cancer. BMJ. doi:10.1136/ijgc-2021-003144.

International Journal of Gynecologic CancerJournal

ADAGIO: A Phase Iib International Study of the Wee1 Inhibitor Adavosertib in Women with Recurrent or Persistent Uterine Serous Carcinoma

clinicaltrials.govStudy

A Study of Adavosertib as Treatment for Uterine Serous Carcinoma

2020. "A Study of Adavosertib as Treatment for Uterine Serous Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590248.