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ATR Kinase Inhibitor

Adavosertib Before Surgery for Ovarian Cancer

Phase < 1

Waitlist Available

Led By Shannon N 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how a drug affects the DNA of patients with advanced ovarian cancer to see if it can help doctors plan more effective treatment.

Who is the study for?

This trial is for women with advanced high-grade ovarian, fallopian tube, or primary peritoneal cancer who haven't had prior treatment for these conditions. Participants must be able to swallow pills, use effective contraception if of childbearing potential, and have no gastrointestinal issues affecting medication absorption. They should understand the study and consent to it, meet certain health criteria including an ECOG status of 0 or 1, and be scheduled for surgery within a specific timeframe.

What is being tested?

The trial is testing how adavosertib affects tumor DNA in patients undergoing surgery for aggressive cancers of the ovary, fallopian tube, or peritoneum. It's an early phase I pilot study aimed at understanding DNA characteristics that influence treatment response to help plan better therapies.

What are the potential side effects?

While not explicitly listed in the provided information, side effects from adavosertib may include nausea, fatigue, blood count changes (like low white blood cells), diarrhea and other gastrointestinal symptoms based on similar medications' profiles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in level of deoxyribonucleic acid (DNA) copy number in p53-related pathways

Change in level of protein expression in p53-related pathways

Change in level of ribonucleic acid (RNA) expression in p53-related pathways

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%

Constipation

30%

Hypermagnesemia

30%

Hypomagnesemia

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%

Tumor pain

10%

Muscle weakness upper limb

10%

Bruising

10%

Localized edema

10%

Lymphedema

10%

Eye disorders - Other, Visual disturbance

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%

Lethargy

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

1Treatment groups

Experimental Treatment

Group I: Treatment (adavosertib)Experimental Treatment2 Interventions

Patients receive adavosertib PO QD on days 1-5. Patients then undergo standard of care laparoscopy. Patients may also receive adavosertib PO QD on days 8-12, 15-19, and 22-26 for up to 28 days based on surgery schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adavosertib

2015

Completed Phase 2

~570

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