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ATR Kinase Inhibitor

Adavosertib + Olaparib for Recurrent Ovarian Cancer

Phase 2

Waitlist Available

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

No Placebo-Only Group

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 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

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%

Diarrhea

70%

Anemia

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%

Alopecia

30%

Hypermagnesemia

30%

Hypomagnesemia

30%

Constipation

30%

Insomnia

30%

Pain

30%

Pain in extremity

30%

Dizziness

30%

Hypertension

30%

Dehydration

30%

Hypocalcemia

30%

Weight loss

20%

Hyponatremia

20%

Hematuria

20%

Allergic rhinitis

20%

Alanine aminotransferase increased

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%

Alkalosis

10%

Lethargy

10%

Muscle weakness upper limb

10%

Bruising

10%

Localized edema

10%

Lymphedema

10%

Eye disorders - Other, Visual disturbance

10%

Tumor pain

10%

Pulmonary edema

10%

Investigations - Other, ELEVATED LDH

10%

Infections and infestations - Other, Retropharyngeal infection

10%

Skin and subcutaneous tissue disorders - Other, SMEGMA

10%

Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY

10%

Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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