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Angiogenesis Inhibitor
Cediranib + Olaparib for 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
Summary
This trial is testing a combination of two drugs to treat patients with solid tumors. Cediranib maleate blocks enzymes needed for cell growth, and olaparib may make the tumor more sensitive to Cediranib maleate.
Who is the study for?
This trial is for adults with advanced or inoperable solid tumors, including breast, non-small cell lung, small cell lung, and pancreatic cancers. Participants must have had at least one standard treatment previously and be able to take oral medication. They should not be pregnant or breastfeeding and must use effective contraception. People with recent significant bleeding, heart issues, other invasive cancers within the last 3 years, untreated brain metastases, or those on certain drugs affecting liver enzymes are excluded.
What is being tested?
The study tests a combination of two drugs: Cediranib Maleate and Olaparib in patients with various advanced solid tumors. The goal is to see if these drugs can stop tumor growth by inhibiting specific enzymes needed for cell proliferation and cutting off oxygen supply to the tumor cells.
What are the potential side effects?
Potential side effects may include gastrointestinal symptoms like nausea and vomiting due to both medications' effect on enzyme inhibition; fatigue from energy depletion in cancer cells; risk of bleeding as cediranib affects blood vessel formation; possible heart complications related to cediranib's impact on oxygen flow.
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
Objective Response Rate
Secondary study objectives
Incidence of Adverse Events
Progression-free Survival
Other study objectives
Changes in Level of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (All Cohorts)
Changes in Levels of Angiogenesis/ Inflammatory Markers (Angiome Panel) (All Cohorts)
Changes in Tumor Hypoxia by Imaging
+1 moreSide effects data
From 2016 Phase 2 trial • 53 Patients • NCT0113282081%
Fatigue
69%
Diarrhea
60%
Hypertension
48%
Anorexia
46%
Nausea
35%
Anemia
33%
Weight Loss
31%
Vomiting
31%
Peripheral Sensory Neuropathy
29%
Mucositis Oral
29%
Hypothyroidism
27%
Constipation
25%
Aspartate Aminotransferase Increased
23%
Headache
23%
Abdominal Pain
23%
Platelet Count Decreased
23%
Creatinine Increased
23%
White Blood Cell Decreased
21%
Urinary Tract Infection
21%
Pain
21%
Hyponatremia
21%
Proteinuria
19%
Hypoalbuminemia
19%
Alanine Aminotransferase Increased
19%
Hypomagnesemia
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dehydration
10%
Voice Alteration
10%
Dizziness
10%
Oral Pain
8%
Palmar-Plantar Erythrodysesthesia Syndrome
8%
Hoarseness
8%
Neoplasms Benign, Malignant And Unspecified (Incl
8%
Arthralgia
8%
Dyspepsia
8%
Neutrophil Count Decreased
8%
Back Pain
8%
Anxiety
6%
Dry Skin
6%
Hypoglycemia
6%
Cough
6%
Thromboembolic Event
6%
Generalized Muscle Weakness
6%
Blurred Vision
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Fecal Incontinence
4%
Upper Respiratory Infection
4%
Flatulence
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Rash Maculo-Papular
4%
Alopecia
4%
Dysgeusia
4%
Epistaxis
4%
Abdominal Distension
4%
Bladder Infection
4%
Dry Eye
4%
Rectal Hemorrhage
4%
Gastroesophageal Reflux Disease
4%
Edema Limbs
4%
Inr Increased
4%
Activated Partial Thromboplastin Time Prolonged
4%
Hypophosphatemia
4%
Hypernatremia
4%
Hyperkalemia
4%
Pelvic Pain
4%
Cognitive Disturbance
2%
Urinary Tract Obstruction
2%
Bullous Dermatitis
2%
Middle Ear Inflammation
2%
Acidosis
2%
Gallbladder Pain
2%
Edema Face
2%
Hemoglobin Increased
2%
Acute Kidney Injury
2%
Vaginal Hemorrhage
2%
Pruritus
2%
Blood Bilirubin Increased
2%
Breast Pain
2%
Lymphocyte Count Decreased
2%
General Disorders And Administration Site Conditio
2%
Nasal Congestion
2%
Blood And Lymphatic System Disorders - Other
2%
Rectal Pain
2%
Cholesterol High
2%
Gastric Hemorrhage
2%
Ascites
2%
Esophageal Pain
2%
Gait Disturbance
2%
Muscle Weakness Lower Limb
2%
Chest Wall Pain
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Multi-Organ Failure
2%
Pleuritic Pain
2%
Allergic Rhinitis
2%
Pain In Extremity
2%
Hypotension
2%
Oral Hemorrhage
2%
Peripheral Motor Neuropathy
2%
Colitis
2%
Anal Hemorrhage
2%
Oral Dysesthesia
2%
Gastrointestinal Pain
2%
Joint Range Of Motion Decreased
2%
Hematuria
2%
Vaginal Pain
2%
Confusion
2%
Death Nos
2%
Myocardial Infarction
2%
Colonic Perforation
2%
Rectal Fistula
2%
Ileal Obstruction
2%
Peritoneal Necrosis
2%
Lung Infection
2%
Chest Pain - Cardiac
2%
Sinus Tachycardia
2%
Sinus Bradycardia
2%
Vertigo
2%
Conjunctivitis
2%
Endocrine Disorders - Other
2%
Eye Disorders - Other
2%
Hyperthyroidism
2%
Dysphagia
2%
Gastric Ulcer
2%
Flu Like Symptoms
2%
Skin Infection
2%
Investigations - Other
2%
Chills
2%
Lipase Increased
2%
Syncope
2%
Neck Pain
2%
Flank Pain
2%
Intracranial Hemorrhage
2%
Memory Impairment
2%
Vaginal Dryness
2%
Depressed Level Of Consciousness
2%
Depression
2%
Skin Induration
2%
Urinary Tract Pain
2%
Respiratory Failure
2%
Hot Flashes
2%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cediranib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cediranib maleate, olaparib)Experimental Treatment5 Interventions
Patients receive cediranib maleate PO QD on day 1. Patients undergoing FMISO scan also receive olaparib PO BID beginning the day after the second FMISO scan and the rest of the patients receive olaparib PO BID beginning day 4 of cycle 1. Cycles repeat every 28 days (35 days for cycle 1) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2007
Completed Phase 4
~2190
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,878 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,687 Total Patients Enrolled
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
299 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have certain levels of blood cells and chemicals in your blood for this study.You have been diagnosed with certain types of cancer that has spread or cannot be removed with surgery.You are using natural herbal products, alternative medications, or folk remedies.You have had a significant amount of coughing up blood or bleeding in the past month.You have been classified as having severe heart failure by your doctor.You are able to perform daily activities without help or with some help.You have had another type of cancer in the past 3 years.You should not have any blood clotting or bleeding problems.You have a hole in the middle of a lung lesion.You currently have a heart rhythm problem that needs to be treated with medication.You do not have signs of myelodysplastic syndrome or acute myelogenous leukemia in your blood or bone marrow samples.Any side effects from previous treatment should be minor according to the National Cancer Institute's grading system.You are expected to live for at least 4 more months.You have had a stroke or mini-stroke in the last 6 months before joining the study.You have already tried at least one standard treatment for your advanced or spreading cancer.You have had allergic reactions to drugs similar to cediranib or olaparib.You have untreated cancer that has spread to your brain or spinal cord, or you have symptoms from cancer that has spread to your brain covering.You had a heart attack within the 6 months before signing up for the study.You must have a way for the doctors to measure your disease according to specific guidelines.You are taking medications or substances that strongly affect how your body processes certain drugs.You have a severe illness, ongoing infection, or mental health issues that could make it hard for you to follow the study rules.You have already taken a medication that blocks VEGF signaling and a PARP inhibitor together.You have certain factors that make you more likely to have heart problems, and you need to have a heart scan showing normal function within the last 3 months.You had a major surgery or significant injury within the last 28 days before starting cediranib.You have HIV and are taking a combination of drugs to manage it.You have a serious condition affecting your blood vessels in your arms or legs, or a bulge in the main blood vessel in your abdomen.Your thyroid function and blood pressure are well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cediranib maleate, 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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