Cediranib Maleate for Stage IIIB Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage IIIB Non-Small Cell Lung Cancer+24 MoreCediranib Maleate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Pancreatic Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Pancreatic Cancer Metastatic
  • Stage IIIA Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer (SCLC)
  • Unresectable Pancreatic Cancer
  • Triple Negative Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Stage IV Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Unresectable Lung Small Cell Carcinoma
  • Stage III Non-Small Cell Lung Cancer
  • Unresectable Triple-Negative Breast Cancer
  • Stage III Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IV Breast Cancer
  • Metastatic Triple-Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 2 years

Baseline to post therapy
DNA
Baseline to post-cediranib monotherapy
Changes in tumor hypoxia by imaging
Baseline to post-therapy
Changes in levels of angiogenesis/ inflammatory markers (angiome panel) (all cohorts)
Week 4
Progression-free survival
Up to 2 years
Neoplasms
Week 4
Incidence of adverse events
Objective response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Cediranib
81%Fatigue
69%Diarrhea
60%Hypertension
48%Anorexia
46%Nausea
35%Anemia
33%Weight Loss
31%Vomiting
31%Peripheral Sensory Neuropathy
29%Hypothyroidism
29%Mucositis Oral
27%Constipation
25%Aspartate Aminotransferase Increased
23%Abdominal Pain
23%Platelet Count Decreased
23%Creatinine Increased
23%White Blood Cell Decreased
23%Headache
21%Pain
21%Urinary Tract Infection
21%Hyponatremia
21%Proteinuria
19%Hypokalemia
19%Alanine Aminotransferase Increased
19%Hypoalbuminemia
19%Hypomagnesemia
17%Dry Mouth
17%Hyperglycemia
15%Alkaline Phosphatase Increased
15%Hypocalcemia
15%Dyspnea
13%Myalgia
10%Oral Pain
10%Dehydration
10%Dizziness
10%Voice Alteration
8%Arthralgia
8%Neoplasms Benign, Malignant And Unspecified (Incl
8%Dyspepsia
8%Neutrophil Count Decreased
8%Back Pain
8%Anxiety
8%Hoarseness
8%Palmar-Plantar Erythrodysesthesia Syndrome
6%Insomnia
6%Tinnitus
6%Blurred Vision
6%Fever
6%Bruising
6%Hypoglycemia
6%Generalized Muscle Weakness
6%Cough
6%Dry Skin
6%Thromboembolic Event
4%Bladder Infection
4%Dry Eye
4%Rectal Hemorrhage
4%Abdominal Distension
4%Gastroesophageal Reflux Disease
4%Fecal Incontinence
4%Flatulence
4%Edema Limbs
4%Upper Respiratory Infection
4%Inr Increased
4%Activated Partial Thromboplastin Time Prolonged
4%Hypophosphatemia
4%Hypernatremia
4%Hyperkalemia
4%Dysgeusia
4%Pelvic Pain
4%Cognitive Disturbance
4%Rash Maculo-Papular
4%Epistaxis
4%Skin And Subcutaneous Tissue Disorders - Other
4%Alopecia
2%Colitis
2%Vaginal Pain
2%Hematuria
2%Oral Dysesthesia
2%Joint Range Of Motion Decreased
2%Anal Hemorrhage
2%Peripheral Motor Neuropathy
2%Ascites
2%Confusion
2%Death Nos
2%Myocardial Infarction
2%Colonic Perforation
2%Rectal Fistula
2%Ileal Obstruction
2%Multi-Organ Failure
2%Peritoneal Necrosis
2%Lung Infection
2%Urinary Tract Obstruction
2%Chest Pain - Cardiac
2%Blood And Lymphatic System Disorders - Other
2%Middle Ear Inflammation
2%Sinus Tachycardia
2%Sinus Bradycardia
2%Vertigo
2%Conjunctivitis
2%Endocrine Disorders - Other
2%Eye Disorders - Other
2%Hyperthyroidism
2%Gastrointestinal Pain
2%Dysphagia
2%Oral Hemorrhage
2%Gastric Hemorrhage
2%Esophageal Pain
2%Gastric Ulcer
2%Rectal Pain
2%General Disorders And Administration Site Conditio
2%Flu Like Symptoms
2%Gait Disturbance
2%Edema Face
2%Skin Infection
2%Investigations - Other
2%Gallbladder Pain
2%Hemoglobin Increased
2%Chills
2%Lymphocyte Count Decreased
2%Lipase Increased
2%Cholesterol High
2%Blood Bilirubin Increased
2%Syncope
2%Muscle Weakness Lower Limb
2%Acidosis
2%Pain In Extremity
2%Neck Pain
2%Chest Wall Pain
2%Flank Pain
2%Reversible Posterior Leukoencephalopathy Syndrome
2%Intracranial Hemorrhage
2%Memory Impairment
2%Vaginal Dryness
2%Depressed Level Of Consciousness
2%Depression
2%Skin Induration
2%Urinary Tract Pain
2%Acute Kidney Injury
2%Breast Pain
2%Nasal Congestion
2%Pruritus
2%Respiratory Failure
2%Vaginal Hemorrhage
2%Pleuritic Pain
2%Allergic Rhinitis
2%Bullous Dermatitis
2%Hypotension
2%Hot Flashes
2%Hematoma
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01132820) in the Cediranib ARM group. Side effects include: Fatigue with 81%, Diarrhea with 69%, Hypertension with 60%, Anorexia with 48%, Nausea with 46%.

Trial Design

1 Treatment Group

Treatment (cediranib maleate, olaparib)
1 of 1

Experimental Treatment

126 Total Participants · 1 Treatment Group

Primary Treatment: Cediranib Maleate · No Placebo Group · Phase 2

Treatment (cediranib maleate, olaparib)Experimental Group · 5 Interventions: Cediranib Maleate, Laboratory Biomarker Analysis, Olaparib, Positron Emission Tomography, 18F-Fluoromisonidazole · Intervention Types: Drug, Other, Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
Not yet FDA approved
Olaparib
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2820

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,988 Previous Clinical Trials
91,857,490 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,988 Total Patients Enrolled
26 Trials studying Stage IIIB Non-Small Cell Lung Cancer
4,646 Patients Enrolled for Stage IIIB Non-Small Cell Lung Cancer
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
299 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who have one of the following types of cancer are eligible for the study: non-small cell lung cancer, triple-negative breast cancer, pancreatic adenocarcinoma, or small cell lung cancer
The text states that for patients with NSCLC, locally advanced or metastatic disease, they must have received one line of standard systemic treatment, which could be a PD-1/PD-L1 inhibitor, platinum-containing chemotherapy, EGFR tyrosine kinase inhibitor, or ALK inhibitor if a sensitizing mutation is present
Patients who have completed prior therapy (except for hair loss) should have any toxicities resolved to a level of grade 1 or lower, as per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0
is a predictor of sepsis A high absolute neutrophil count increases the likelihood of sepsis.
Patients must have tumor that can be measured using RECIST v1.1.
People with ECOG performance status 0, 1 or 2 are likely to live at least six months.
A person who is expected to live for four months or more.