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ATR Kinase Inhibitor

Adavosertib + Olaparib for Recurrent Ovarian Cancer

Phase 2
Recruiting
Led By Shannon Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer for which there is no known or established treatment available with curative intent.
Are germline or somatic BRCA mutant or HRD positive by a licensed test prior to enrollment.
Must not have
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial is testing adavosertib with or without olaparib to treat patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back.

Who is the study for?
This trial is for adults with recurrent ovarian, primary peritoneal, or fallopian tube cancer who've seen their disease progress on PARP inhibitors. They should have a measurable lesion and be in relatively good health (ECOG score 0-1). Women must not be pregnant, breastfeeding, and agree to use contraception. People can't join if they have heart issues like long QT syndrome, uncontrolled brain metastases, severe reactions to study drugs or certain drug interactions.
What is being tested?
The trial tests adavosertib alone or combined with olaparib in patients whose cancer has returned. These drugs may block enzymes that tumor cells need to grow. Participants are chosen for different treatment groups based on specific criteria and will receive the treatments to see which works better.
What are the potential side effects?
Adavosertib and olaparib might cause side effects such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. There could also be liver issues or allergic reactions among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian, peritoneal, or fallopian tube cancer has returned and cannot be cured with available treatments.
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My cancer is BRCA mutant or HRD positive.
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I am 18 years old or older.
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I have saved tissue samples from before my PARP inhibitor treatment.
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My cancer progressed despite being on a PARP inhibitor treatment.
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I have seen improvement with PARP inhibitor treatment for at least 6 months.
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My organs and bone marrow are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a blood transfusion in the last 4 months.
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I do not have a serious infection or condition that would stop me from receiving the study treatment.
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I cannot swallow pills or have a stomach condition that affects medication absorption.
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I have not had serious heart problems in the last 6 months.
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My heart's electrical activity (QTc interval) is normal.
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I have had a bone marrow or double umbilical cord blood transplant.
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I have heart conditions or family history that could affect my heart's rhythm.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I am not taking any strong or moderate drugs that affect liver enzymes.
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I have high blood pressure that needs treatment.
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I have been diagnosed with ataxia telangiectasia.
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I have experienced side effects from previous treatments, but not hair loss or loss of appetite.
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I am not taking strong or moderate drugs that affect liver enzymes.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate
Secondary study objectives
Disease control rate

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%
Alopecia
30%
Hypomagnesemia
30%
Constipation
30%
Hypermagnesemia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Alanine aminotransferase increased
20%
Allergic rhinitis
20%
Hematuria
20%
Hyponatremia
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%
Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY
10%
Tumor pain
10%
Muscle weakness upper limb
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
10%
Lymphedema
10%
Eye disorders - Other, Visual disturbance
10%
Pulmonary edema
10%
Investigations - Other, ELEVATED LDH
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Alkalosis
10%
Lethargy
10%
Bruising
10%
Localized edema
10%
Photophobia
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%
0%
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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (ceralasertib, olaparib)Experimental Treatment2 Interventions
Patient receive ceralasertib tablets by PO BID each day on Days 1-14. You will also take olaparib tablets by PO BID each day on Days 1-28.
Group II: Arm II (olaparib, adavosertib)Experimental Treatment2 Interventions
Patients receive olaparib PO BID on days 1-21 and adavosertib PO QD on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (adavosertib)Active Control1 Intervention
Patients receive adavosertib PO QD on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Ceralasertib
2017
Completed Phase 1
~40
Adavosertib
2015
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,597 Total Patients Enrolled
48 Trials studying Ovarian Cancer
16,789 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,896 Total Patients Enrolled
291 Trials studying Ovarian Cancer
74,941 Patients Enrolled for Ovarian Cancer
Shannon WestinPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

Adavosertib (ATR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03579316 — Phase 2
Ovarian Cancer Research Study Groups: Arm III (ceralasertib, olaparib), Arm I (adavosertib), Arm II (olaparib, adavosertib)
Ovarian Cancer Clinical Trial 2023: Adavosertib Highlights & Side Effects. Trial Name: NCT03579316 — Phase 2
Adavosertib (ATR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03579316 — Phase 2
~4 spots leftby Dec 2024
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