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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My ovarian, peritoneal, or fallopian tube cancer has returned and cannot be cured with available treatments.
Select...
My cancer is BRCA mutant or HRD positive.
Select...
I am 18 years old or older.
Select...
I have saved tissue samples from before my PARP inhibitor treatment.
Select...
My cancer progressed despite being on a PARP inhibitor treatment.
Select...
I have seen improvement with PARP inhibitor treatment for at least 6 months.
Select...
My organs and bone marrow are functioning well.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
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%
Neutrophil count decreased
40%
Anxiety
40%
Aspartate aminotransferase increased
40%
Dyspnea
40%
Headache
40%
Platelet count decreased
30%
Insomnia
30%
Hypermagnesemia
30%
Constipation
30%
Alopecia
30%
Hypomagnesemia
30%
Pain
30%
Pain in extremity
30%
Dizziness
30%
Hypertension
30%
Dehydration
30%
Hypocalcemia
30%
Weight loss
20%
Hematuria
20%
Allergic rhinitis
20%
Hyponatremia
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%
Localized edema
10%
Investigations - Other, ELEVATED LDH
10%
Pulmonary edema
10%
Tumor pain
10%
Muscle weakness upper limb
10%
Skin and subcutaneous tissue disorders - Other, SMEGMA
10%
Infections and infestations - Other, Retropharyngeal infection
10%
Bruising
10%
Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY
10%
Lethargy
10%
Lymphedema
10%
Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION
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%
Eye disorders - Other, Visual disturbance
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%
Photophobia
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
~2140
Ceralasertib
2017
Completed Phase 1
~30
Adavosertib
2015
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,261 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,745 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,291 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,708 Patients Enrolled for Ovarian Cancer
Shannon WestinPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
134 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

Frequently Asked Questions

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

Does this medical experiment introduce a new method of treatment?

"At present, 202 separate experiments utilizing Adavosertib are being conducted across 1629 cities and 60 nations. Initially studied in 2005 by AstraZeneca with 98 participants, the Phase 1 drug approval stage of this trial has been successfully completed. In the intervening years since then, 85 trials have finished their course."

Answered by AI

What potential adverse outcomes might be associated with Adavosertib usage?

"Our experts rank the safety of Adavosertib as a 2, due to this Phase 2 trial having some data demonstrating its safe usage but none providing evidence for effectiveness."

Answered by AI

Could you provide a synopsis of the research thus far conducted on Adavosertib?

"First studied in 2005, adavosertib has had 85 trials completed and over 200 ongoing investigations. Of those currently active studies, a significant portion are conducted within the Boston area of Massachusetts."

Answered by AI

What medical conditions can be addressed with the use of Adavosertib?

"Adavosertib is typically prescribed to treat late-stage diseases, including malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations with physical symptoms."

Answered by AI

Are there any openings remaining for individuals to participate in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this trial is currently seeking participants, having initially been posted on December 7th 2018 and last updated August 31st 2022. 104 individuals need to be recruited from two separate medical facilities."

Answered by AI

How many individuals are being recruited to participate in this trial?

"Affirmative. Per the information housed on clinicaltrials.gov, this medical trial is actively accepting participants. The initial posting was made on December 7th 2018 and the listing has been updated as recently as August 31st 2022. This study requires 104 individuals to be recruited from two distinct sites."

Answered by AI
~13 spots leftby Dec 2024