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ATR Kinase Inhibitor

Adavosertib for Ovarian Cancer

Phase 2

Waitlist Available

Led By Kathleen Moore, MD

Research Sponsored by AstraZeneca

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 throughout the study, approximately 4 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, adavosertib, in combination with other drugs that are commonly used to treat ovarian cancer.

Eligible Conditions

Ovarian Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 4 years 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 (ORR)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DoR)

Gynecologic Cancer Intergroup (GCIG) CA-125 Response

+19 more

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%

Hypomagnesemia

30%

Alopecia

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%

Hyponatremia

20%

Hematuria

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%

Muscle weakness upper limb

10%

Investigations - Other, ELEVATED LDH

10%

Lymphedema

10%

Photophobia

10%

Pulmonary edema

10%

Skin and subcutaneous tissue disorders - Other, HAIR DEPIGMENTATION

10%

Skin and subcutaneous tissue disorders - Other, SMEGMA

10%

Lethargy

10%

Infections and infestations - Other, Retropharyngeal infection

10%

Tumor pain

10%

Alkalosis

10%

Bruising

10%

Eye disorders - Other, Visual disturbance

10%

Localized edema

10%

Musculoskeletal and connective tissue disorder - Other, GROWTH PLATE ABNORMALITY

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (adavosertib + PLD)Experimental Treatment2 Interventions

Five doses of adavosertib (175 mg or 225 mg) will be taken in approximate 12 hour intervals over 2.5 days (Days 1, 2, and 3) of each 28-day cycle. PLD will administered IV on Day 1 of each cycle.

Group II: Arm C/C2 (adavosertib + carboplatin)Experimental Treatment2 Interventions

Arm C: Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days (Days 1-3). Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21-Day cycle. Arm C2: Five doses of adavosertib (225 mg PO BID) 2.5 days per dosing week (QW), on Weeks 1 (D1-3), 2 (D8-10) and 3 (D15-17), or on Weeks 1 (D1-3) and 2 (D8-10) ( 2 weeks on followed by 1 week off.) Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21 day cycle.

Group III: Arm B (adavosertib + paclitaxel)Experimental Treatment2 Interventions

Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days weekly (Days 1-3, 8-10, and 15-17). Weekly paclitaxel 80 mg/m² IV will be administered according to institutional standards on Day 1, 8, and 15 of each 28 day cycle.

Group IV: Arm A (adavosertib + gemcitabine)Experimental Treatment2 Interventions

Adavosertib (175 mg PO) will be taken on Days 1-2, 8-9, and 15-16. Gemcitabine 800 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adavosertib

2015

Completed Phase 2

~570

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Gemcitabine

2017

Completed Phase 3

~2070

PLD

2015

Completed Phase 3

~1420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,267 Previous Clinical Trials

288,606,886 Total Patients Enrolled

48 Trials studying Ovarian Cancer

23,850 Patients Enrolled for Ovarian Cancer

Kathleen Moore, MDPrincipal InvestigatorStephenson Cancer Center, University of Oklahoma Health Sciences Center

8 Previous Clinical Trials

350 Total Patients Enrolled

1 Trials studying Ovarian Cancer

27 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

To what extent can Adavosertib pose a threat to patient health?

"Our team at Power assigned Adavosertib a score of 2, given that this trial is in its second phase and only limited safety data exists. No efficacy has been established yet."

Answered by AI

Is the study actively seeking participants at this time?

"According to clinicaltrials.gov this trial has halted enrollment; the most recent changes were made on November 23rd, 2022 and it was originally posted in January 30th, 2015. However, there are still 1,530 other studies recruiting patients at present."

Answered by AI

What health conditions can Adavosertib be deployed to address?

"Adavosertib is frequently prescribed for non-Hodgkin lymphoma, as well as advanced local and metastatic bladder cancer, and initial treatment of non-small cell lung cancer."

Answered by AI

Is it feasible for me to join this research project?

"This medical trial is seeking 95 patients to evaluate the efficacy of a novel treatment for peritoneal neoplasms. Candidates must be between 18 and 130 years old in order to qualify."

Answered by AI

In what geographic regions is this research accessible?

"This research is currently recruiting patients from 18 different sites, including those in Milwaukee Abington, and Augusta. Prospective participants should consider choosing the clinic closest to them in order to reduce their travel burden."

Answered by AI

Does this experiment include participants aged 45 or older?

"This experimental trial has established a lower threshold of 18 years old and an upper limit at 130, which must be met to qualify."

Answered by AI

How many participants are enrolled in this clinical trial?

"This study is no longer taking on new participants. The trial's posting date was January 30th 2015 and the last update happened November 23rd 2022; anyone seeking to participate in a similar medical venture should explore the 104 trials recruiting patients with peritoneal neoplasms or the 1426 studies for Adavosertib that are accepting volunteers."

Answered by AI

What prior investigations have shed light on Adavosertib's effects?

"First researched in 1997, adavosertib's clinical trials have now reached 2203 completed studies. 1426 of these trails are still undergoing evaluation, with many locations situated around Milwaukee Wisconsin."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Adavosertib with Chemotherapy in Patients with Primary Platinum-resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: An Open-label, Four-arm, Phase II Study

Moore, Kathleen N., Setsuko K. Chambers, Erika P. Hamilton, Lee-may Chen, Amit M. Oza, Sharad A. Ghamande, Gottfried E. Konecny, et al.. 2022. “Adavosertib with Chemotherapy in Patients with Primary Platinum-resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: An Open-label, Four-arm, Phase II Study”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-0158.

clinicaltrials.govStudy

Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2015. "Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02272790.