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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
Consent to provide archival tumor tissue for correlative biomarker studies
Have histologically/cytologically-documented, locally-advanced, or metastatic mismatch repair proficient colorectal cancer (MMRp-CRC), pancreatic adenocarcinoma (PA), or leiomyosarcoma (LMS) that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the subject and treating physician
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Leiomyosarcoma
- Pancreatic Adenocarcinoma
- Colorectal Cancer
DAPPER Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You agree to provide a sample of your tumor tissue for research purposes.
Select...
You have advanced colorectal cancer, pancreatic adenocarcinoma or leiomyosarcoma that cannot be cured and have not responded to standard treatments. If no standard treatment is available, or if you and your doctor decide not to use it, you may be eligible for the trial.
Select...
You must agree to provide a fresh sample of your tumor tissue taken no more than 4 weeks before starting the study. If you don't have a fresh sample, you can still participate if you have a stored sample that is less than 6 months old and taken before any other treatments. You will need to undergo a pre-treatment biopsy.
Select...
You must have at least one tumor that can be measured by CT or MRI scan. If you've had radiation treatment before, a previously treated tumor may count if it has grown since the treatment. The biopsy site cannot be the same as the tumor being measured.
Select...
You are allowed to have received immune-oncology therapy in the past, and there is no maximum limit to the number of prior treatments you have had for advanced or metastatic disease. However, you must stop all anti-cancer treatments, including immune-oncology, for at least 4 weeks before starting the trial. There is no limit to the number of prior anti-cancer treatments you can have had before enrolling in the trial.
Select...
You must have at least one tumor site that can be biopsied.
Select...
Your doctor predicts that you will live for at least 16 more weeks from the start of the trial.
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 • 46 Patients • NCT03003520100%
Neutropenia
67%
Fatigue
67%
Constipation
67%
Peripheral sensory neuropathy
67%
Nausea
67%
Stomatitis
33%
Hypoacusis
33%
Pneumonia
33%
Febrile neutropenia
33%
Spinal pain
33%
Oedema peripheral
33%
Muscle spasms
33%
Rash
33%
Oral herpes
33%
Anaemia
33%
Leukopenia
33%
Thrombocytopenia
33%
Gastrooesophageal reflux disease
33%
Hypokalaemia
33%
Dizziness
33%
Restless legs syndrome
33%
Sensory disturbance
33%
Diarrhoea
33%
Infusion related reaction
33%
Blood pressure increased
33%
Platelet count decreased
33%
Histiocytic necrotising lymphadenitis
33%
Cognitive disorder
33%
Dysuria
33%
Pulmonary embolism
33%
Erythema
33%
Generalised erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
DUR + R2-CHOP
DUR + R-CHOP
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3890
Olaparib
2017
Completed Phase 4
~1430
Durvalumab
2017
Completed Phase 2
~3030
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,178 Previous Clinical Trials
289,626,910 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,430 Previous Clinical Trials
482,557 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
56 Patients Enrolled for Leiomyosarcoma
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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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