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PARP Inhibitor
Cediranib + Olaparib for Advanced Prostate Cancer
Phase 2
Waitlist Available
Led By Joseph W Kim
Research Sponsored by National Cancer Institute (NCI)
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 up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well olaparib, with or without cediranib, works to treat patients with metastatic prostate cancer. Olaparib is a PARP inhibitor, which means it prevents PARP proteins from repairing DNA mutations. This may stop tumor cells from growing. Cediranib is an enzyme inhibitor that may also stop tumor cell growth.
Who is the study for?
Men with advanced prostate cancer that has spread and is resistant to castration treatment. Participants must have had at least one prior therapy for metastatic castration-resistant prostate cancer (mCRPC), be able to swallow pills, and not have untreated brain metastases or a history of allergic reactions to similar drugs. They should also meet specific health criteria like controlled blood pressure, adequate organ function, and agree to use contraception.
What is being tested?
The trial is testing if combining two oral medications, Cediranib and Olaparib, is more effective than using just Olaparib in men with advanced prostate cancer. The study will randomly assign participants into groups receiving either the combination or the single drug to compare their effects on tumor growth.
What are the potential side effects?
Possible side effects include nausea, fatigue, anemia (low red blood cell counts), increased risk of bleeding or clotting issues due to changes in platelet count or coagulation parameters, high blood pressure management needs when taking Cediranib, and potential heart-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiographic progression free survival
Secondary study objectives
Correlation between homologous recombination deficiency status and radiographic progression free survival
Incidence of adverse events
Incidence of genomic alterations
+3 moreOther study objectives
Baseline predictive biomarkers by plasma angiome
On-treatment markers of acquired resistance by plasma angiome
Side effects data
From 2015 Phase 2 & 3 trial • 1814 Patients • NCT0038417677%
Diarrhoea
52%
Nausea
48%
Hypertension
47%
Fatigue
45%
Neutropenia
40%
Stomatitis
37%
Decreased Appetite
34%
Vomiting
29%
Thrombocytopenia
26%
Neuropathy Peripheral
26%
Abdominal Pain
25%
Dysphonia
24%
Headache
24%
Epistaxis
24%
Paraesthesia
19%
Peripheral Sensory Neuropathy
18%
Constipation
17%
Weight Decreased
16%
Palmar-Plantar Erythrodysaesthesia Syndrome
16%
Asthenia
14%
Dyspnoea
14%
Pyrexia
13%
Dysgeusia
13%
Hypothyroidism
12%
Proteinuria
12%
Cough
11%
Abdominal Pain Upper
11%
Nasopharyngitis
10%
Leukopenia
10%
Back Pain
9%
Alopecia
8%
Hypokalaemia
8%
Urinary Tract Infection
8%
Pain In Extremity
8%
Anaemia
8%
Dizziness
8%
Insomnia
8%
Arthralgia
7%
Rash
7%
Oropharyngeal Pain
7%
Oedema Peripheral
6%
Alanine Aminotransferase Increased
6%
Lethargy
6%
Myalgia
6%
Depression
6%
Dysphagia
6%
Dyspepsia
5%
Drug Hypersensitivity
5%
Dry Mouth
5%
Phlebitis
4%
Musculoskeletal Pain
3%
Dehydration
3%
Pulmonary Embolism
2%
Upper Respiratory Tract Infection
1%
Non-Cardiac Chest Pain
1%
Abdominal Abscess
1%
Abdominal Infection
1%
Cognitive Disorder
1%
Atrial Flutter
1%
Gastrointestinal Pain
1%
Ileus
1%
Embolism Venous
1%
Angina Pectoris
1%
Rectal Haemorrhage
1%
Sepsis
1%
Supraventricular Tachycardia
1%
Lobar Pneumonia
1%
Transient Ischaemic Attack
1%
Cerebrovascular Accident
1%
Renal Failure
1%
Vena Cava Thrombosis
1%
Pneumonia
1%
Hypercalcaemia
1%
Haematuria
1%
General Physical Health Deterioration
1%
Pharyngeal Oedema
1%
Left Ventricular Dysfunction
1%
Cerebral Haemorrhage
1%
Oesophagitis
1%
Catheter Related Infection
1%
Pleural Effusion
1%
Agranulocytosis
1%
Intestinal Perforation
1%
Convulsion
1%
Deep Vein Thrombosis
1%
Cardiomyopathy
1%
Enteritis
1%
Gastrointestinal Toxicity
1%
Ileus Paralytic
1%
Large Intestinal Obstruction
1%
Appendicitis
1%
Bronchitis
1%
Catheter Site Cellulitis
1%
Neutropenic Sepsis
1%
Pulmonary Tuberculosis
1%
Syncope
1%
Cerebral Ischaemia
1%
Haemorrhagic Stroke
1%
Vascular Encephalopathy
1%
Subclavian Vein Thrombosis
1%
Thrombosis
1%
Cardiopulmonary Failure
1%
Mitral Valve Incompetence
1%
Myocardial Ischaemia
1%
Intestinal Haemorrhage
1%
Bradyphrenia
1%
Hypertensive Crisis
1%
Febrile Neutropenia
1%
Pancytopenia
1%
Intestinal Obstruction
1%
Gastrointestinal Inflammation
1%
Large Intestine Perforation
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cediranib 30 mg
1Bevacizumab 5mg/kg
Cediranib 20 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (olaparib, cediranib)Experimental Treatment2 Interventions
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (olaparib)Active Control1 Intervention
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 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
Cediranib
2016
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,942 Total Patients Enrolled
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
331 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a blocked bowel within the month before starting the study.You have taken any experimental drugs within the last 28 days before the start of the study.You have cancer that has spread to your brain or spinal cord and have not yet received treatment for it, or you have symptoms of this spreading that affect your brain.You are taking medications that strongly affect CYP3A enzymes, either by increasing or decreasing their activity.You have had another type of cancer in the last 5 years.You have a history of a hole or opening in your stomach or intestines, an infection in your abdomen, or an abnormal connection between your organs.You have experienced bleeding inside your abdomen or back in the last 3 years.You are expected to live for at least 16 weeks.You have newly discovered areas of concern on a bone scan.Your disease has been getting worse according to a specific medical assessment method called RECIST 1.1.You agree to have tissue samples taken from your tumor before and during the study. There is an optional biopsy after the treatment stops working.You have received two or more treatments for metastatic castration-resistant prostate cancer (mCRPC). If you were given a chemotherapy drug called taxane for metastatic castration sensitive disease, it will not count as a prior treatment, unless your cancer progressed within 12 months after the last dose of chemotherapy.You have already received treatment for metastatic castration-resistant prostate cancer (mCRPC) at least once.Your condition must show signs of getting worse, which will be confirmed by specific tests or measurements.You have taken medicine before that blocks VEGF signaling or PARP.You are currently taking natural herbal products or other non-prescription remedies.You have an ongoing and uncontrolled illness.You are willing to have tumor samples taken for research purposes.Your PSA levels have been increasing for at least two tests, and the most recent test shows a value of 1.0 ng/ml or higher. If the PSA level at the third test is higher than at the second test, or if the fourth test is higher than the second test and either the third or fourth test is 1 ng/mL or higher, you may be eligible to participate.You have a significant disease in your blood vessels or a known bulge in your abdominal aorta.You have brain tumors that have been treated but they do not meet specific requirements.You have been diagnosed with prostate cancer, and it has been confirmed by a biopsy or imaging tests. If the cancer has other types of cells, you need to talk to the study leader.The spreading of the cancer to other parts of your body must be confirmed by medical images.If you are a male with prostate cancer, you should have had surgery or medication to lower your testosterone levels. If you are taking medication, you should have started it at least 4 weeks before the study starts and continue taking it throughout the study.You need to have a tumor that can be safely biopsied by the doctor. The doctor may prefer a soft tissue tumor, but a bone tumor is also allowed if enough samples can be taken. The tumor used for the biopsy cannot be used to assess treatment response.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (olaparib, cediranib)
- Group 2: Arm B (olaparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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