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Adavosertib + Durvalumab for Cancer
Phase 1
Waitlist Available
Led By Manish Patel, M.D.
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic confirmation of a solid tumour, excluding lymphoma, refractory to standard therapy or for which no standard of care regimen exists
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated 18 months
Awards & highlights
Study Summary
This trial will study a new cancer drug given orally and intravenously to see if it is safe and works well against tumors.
Who is the study for?
Adults (≥18 years) with solid tumors that are unresponsive to standard treatments or have no standard care available. Participants must weigh at least 30 kg, be able to consent, and have an ECOG Performance Status of 0-1. They should not be pregnant or breastfeeding, agree to use contraception, and meet specific health criteria including blood counts and organ function tests.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: AZD1775 (adavosertib), taken orally, and MEDI4736 (durvalumab), given intravenously. It aims to evaluate their safety, how well they're tolerated by patients' bodies, how they affect the body's handling of drugs (pharmacokinetics), immune response effects (immunogenicity), changes in disease indicators (pharmacodynamics), and initial effectiveness against advanced solid tumors.See study design
What are the potential side effects?
Potential side effects include reactions related to drug infusion into the bloodstream; issues affecting organs due to inflammation; fatigue; gastrointestinal problems like upset stomach or diarrhea; changes in blood cell counts which can affect immunity; as well as other individual-specific reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor does not respond to standard treatments or no treatment exists.
Select...
I am fully active or can carry out light work.
Select...
I weigh at least 30 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Change from baseline in clinical chemistry, hematology, and coagulation parameters
Change from baseline in physical examination findings
Change from baseline in vital signs
+9 moreSide 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%
Alanine aminotransferase increased
3%
Alkaline phosphatase increased
3%
Pneumonitis
3%
Sepsis
3%
Breast pain
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
4Treatment groups
Experimental Treatment
Group I: Dose Schedule DExperimental Treatment2 Interventions
In Schedule D, patients will receive MEDI4736 (durvalumab) by intravenous on Day 1, and AZD1775 (adavosertib) one time per day orally on Days 15-19, and Days 22-26 of a 28-day cycle. In Schedule D there will be a 9-day lead-in period with AZD1775 (adavosertib) being dosed on Days -9 to -5 to enable serial PK measurements prior to initiating MEDI4736 (durvalumab) on Day 1. In all dose schedules, dexamethasone will be administered as an anti-emetic on the first day of the AZD1775 (adavosertib) consecutive dosing day blocks including the lead-in portion of Schedules B, C, and D. Additional alternative dose levels and/or schedules may also be explored if emerging data suggest these would be more appropriate.
Group II: Dose Schedule CExperimental Treatment2 Interventions
In Schedule C, patients will receive MEDI4736 (durvalumab) by intravenous on Day 1, and AZD1775 (adavosertib) twice daily orally on Days 8-10, Days 15-17, and Days 22-24 of a 28-day cycle. In Schedule C there will be a 7-day AZD1775 (adavosertib) lead-in to enable serial PK measurements prior to initiating MEDI4736 (durvalumab) on Day 1. In all dose schedules, dexamethasone will be administered as an anti-emetic on the first day of the AZD1775 (adavosertib) consecutive dosing day blocks including the lead-in portion of Schedules B, C, and D. Additional alternative dose levels and/or schedules may also be explored if emerging data suggest these would be more appropriate.
Group III: Dose Schedule BExperimental Treatment2 Interventions
In Schedule B, patients will receive MEDI4736 (durvalumab) by intravenous on Day 1, and AZD1775 (adavosertib) twice daily orally on Days 15-17 and Days 22-24 of a 28-day cycle. In Schedule B there will be a 7-day AZD1775 (adavosertib) lead-in to enable serial PK measurements prior to initiating MEDI4736 on Day 1. In all dose schedules, dexamethasone will be administered as an anti-emetic on the first day of the AZD1775 (adavosertib) consecutive dosing day blocks including the lead-in portion of Schedules B, C, and D. Additional alternative dose levels and/or schedules may also be explored if emerging data suggest these would be more appropriate.
Group IV: Dose Schedule AExperimental Treatment2 Interventions
In Schedule A, patients will receive MEDI4736 (durvalumab) by intravenous on Day 1, and AZD1775 (adavosertib) twice daily orally on Days 1-5 and Days 15-19 of a 28-day cycle. In all dose schedules, dexamethasone will be administered as an anti-emetic on the first day of the AZD1775 (adavosertib).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD1775
2015
Completed Phase 2
~400
MEDI4736
2016
Completed Phase 3
~5560
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,846 Total Patients Enrolled
Manish Patel, M.D.Principal InvestigatorFlorida Cancer Specialists
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My solid tumor does not respond to standard treatments or no treatment exists.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I am not taking any drugs that are known to be sensitive to CYP3A4.I do not have any severe or uncontrolled illnesses.I have not received a whole blood transfusion in the last 4 months.I am fully active or can carry out light work.I have had cancer spread to the lining of my brain and spinal cord.My blood pressure is not controlled by medication.I finished palliative radiation therapy less than a week ago.I don't have lasting side effects from previous treatments.I need treatment for fluid buildup in my abdomen.I have or had an autoimmune or inflammatory disorder.I have had serious stomach issues causing diarrhea in the last year.I am not allergic to any components of the study drug.I have not received a live vaccine in the last 30 days.I have an active cancer diagnosis.I do not have a serious active infection.I have had a bone marrow transplant from another person.I haven't taken any approved cancer treatments in the last 21 days.I weigh at least 30 kg.I will stop taking herbal supplements 7 days before starting the study drug.I cannot swallow pills.I haven't taken WEE-1 inhibitors or immunosuppressants in the last 14 days.I have interstitial lung disease.I have had an organ transplant and am on immunosuppressive drugs.I understand the study and can agree to participate.I am 18 years old or older.I have had tuberculosis in the past.My brain or spinal tumors are stable, and I haven't taken steroids for over 14 days.I am not on any other cancer treatments while on the study medication.I have had heart problems in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Schedule D
- Group 2: Dose Schedule C
- Group 3: Dose Schedule A
- Group 4: Dose Schedule B
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.
Are there any antecedent experiments with AZD1775?
"Presently, 347 studies are examining AZD1775 with 52 of these in the final stage. Most trials for this therapeutic agent occur in Cordoba, Texas, yet there are 14589 other locations conducting research on it as well."
Answered by AI
Are elderly individuals eligible for participation in this clinical experiment?
"According to the criteria for entry, individuals that are between 18 and 130 years old may take part in this clinical trial."
Answered by AI
What clinical indications is AZD1775 most commonly employed to treat?
"AZD1775 is chiefly prescribed to treat late-stage, inoperable non-small cell lung cancer. However, it can also be helpful for those with metastatic ureteral carcinoma or advanced directives."
Answered by AI
How many participants are currently involved in this research endeavor?
"At present, this medical trial is not recruiting new participants. Initially posted on December 28th 2015 and last updated November 25th 2022, it has since concluded its recruitment process. However, there are 2,387 trials open for those with advanced solid tumours as well as 347 studies enrolling patients to partake in AZD1775 treatments."
Answered by AI
Could you detail the potential harms associated with AZD1775?
"Our team at Power gave AZD1775 a score of 1 as it is in the earliest stage of testing and has limited evidence backing its safety or efficacy."
Answered by AI
Who has the eligibility to become a participant of this clinical research?
"This research requires 56 individuals with advanced solid tumours, aged between 18 and 130, to participate."
Answered by AI
Is there availability for volunteers in this research endeavor?
"This clinical trial is not currently enrolling. The post was originally made on December 28th 2015 and most recently edited in November 25th 2022. For those interested, there are 2387 medical studies actively recruiting patients with advanced solid tumours and 347 trials for AZD1775 seeking enrolment as well."
Answered by AI
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