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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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Secondary outcome measures
Incidence of adverse events
Progression-free survival
Other outcome measures
DNA
Changes in levels of angiogenesis/ inflammatory markers (angiome panel) (all cohorts)
Changes in tumor hypoxia by imaging
+1 more

Side effects data

From 2016 Phase 2 trial • 53 Patients • NCT01132820
81%
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%
Hypomagnesemia
19%
Alanine Aminotransferase Increased
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dizziness
10%
Dehydration
10%
Voice Alteration
10%
Oral Pain
8%
Hoarseness
8%
Palmar-Plantar Erythrodysesthesia Syndrome
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%
Thromboembolic Event
6%
Blurred Vision
6%
Generalized Muscle Weakness
6%
Cough
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Upper Respiratory Infection
4%
Alopecia
4%
Fecal Incontinence
4%
Epistaxis
4%
Flatulence
4%
Abdominal Distension
4%
Rash Maculo-Papular
4%
Dysgeusia
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%
Allergic Rhinitis
2%
Blood And Lymphatic System Disorders - Other
2%
Middle Ear Inflammation
2%
Breast Pain
2%
Pleuritic Pain
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Muscle Weakness Lower Limb
2%
Edema Face
2%
General Disorders And Administration Site Conditio
2%
Acute Kidney Injury
2%
Cholesterol High
2%
Nasal Congestion
2%
Gastric Hemorrhage
2%
Blood Bilirubin Increased
2%
Gallbladder Pain
2%
Lymphocyte Count Decreased
2%
Ascites
2%
Pain In Extremity
2%
Pruritus
2%
Gait Disturbance
2%
Hypotension
2%
Acidosis
2%
Hemoglobin Increased
2%
Multi-Organ Failure
2%
Bullous Dermatitis
2%
Chest Wall Pain
2%
Rectal Pain
2%
Urinary Tract Obstruction
2%
Esophageal Pain
2%
Vaginal Hemorrhage
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
~2210
Positron Emission Tomography
2008
Completed Phase 2
~2210

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,279 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,477 Total Patients Enrolled
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
299 Total Patients Enrolled

Media Library

Cediranib Maleate (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02498613 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment (cediranib maleate, olaparib)
Pancreatic Cancer Clinical Trial 2023: Cediranib Maleate Highlights & Side Effects. Trial Name: NCT02498613 — Phase 2
Cediranib Maleate (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02498613 — Phase 2
~14 spots leftby Jul 2025