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Angiogenesis Inhibitor
Combination Therapy with Cediranib, Olaparib, and Durvalumab for Advanced Solid Tumors (DAPPER Trial)
Phase 2
Waitlist Available
Led By Lillian Siu, MD
Research Sponsored by University Health Network, Toronto
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 3 years
Awards & highlights
DAPPER Trial Summary
This trial is studying a combination of two drugs, olaparib and durvalumab or cediranib and durvalumab, in people with advanced cancer of the colon or rectum, pancreas, or uterus.
Who is the study for?
Adults with advanced colorectal cancer, pancreatic adenocarcinoma, or leiomyosarcoma that's not curable and has failed standard therapy can join. They must be willing to use effective contraception, provide tumor tissue samples, have normal organ function, and no recent major surgeries. Excluded are those with certain heart conditions, uncontrolled hypertension or seizures, recent bleeding events or blood transfusions.Check my eligibility
What is being tested?
The trial tests combinations of Olaparib (a pill for DNA repair inhibition), Cediranib (a pill for blocking blood vessel growth in tumors), and Durvalumab (an IV drug boosting immune response against cancer). Participants will receive treatments based on their assigned cohort to see how these drugs affect tumor biomarkers.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea from Olaparib; high blood pressure and fatigue from Cediranib; infusion reactions like fever or chills and autoimmune-like symptoms such as skin rash or thyroid issues from Durvalumab.
DAPPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in genomic and immune biomarkers that will be measured in the baseline biopsy and the first on-treatment biopsy by applying a log-transformation and the t-test.
Secondary outcome measures
Antitumor activity based on iRECIST
Clinical benefit rate (CBR)
Incidence of treatment-emergent adverse events (AEs)
+3 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
DAPPER Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment2 Interventions
Cediranib (given orally at a dose of 20 mg daily, 5 days on 2 days off) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Group II: Cohort AExperimental Treatment2 Interventions
Olaparib (given orally at a dose of 300 mg twice a day) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
2016
Completed Phase 3
~4030
Olaparib
2007
Completed Phase 4
~2140
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,429 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
56 Patients Enrolled for Leiomyosarcoma
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,696 Total Patients Enrolled
Lillian Siu, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
24 Previous Clinical Trials
14,057 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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