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Kinase Inhibitor

PDR001 for Colorectal Cancer

Phase 2
Recruiting
Led By Ryan Corcoran, MD
Research Sponsored by Massachusetts General Hospital
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 from the date of randomization until the time of death, up to approximately 10 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat metastatic colorectal cancer with the BRAF V600E mutation. The drugs being tested are Dabrafenib, Trametinib, and PDR001.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until the time of death, up to approximately 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the time of death, up to approximately 10 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
Number of participants with grade 3, 4 and 5 adverse events
Overall Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Mechanisms of response and resistance to dabrafenib, trametinib, and PDR001
+2 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
83%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

Trial Design

1Treatment groups
Experimental Treatment
Group I: PDR001, Dabrafenib, TrametinibExperimental Treatment3 Interventions
Patients who fulfill eligibility criteria will be entered into the trial to receive PDR001, Dabrafenib, Trametinib. Treatment will be administered on an outpatient basis. After the screening procedures confirm participation in the research study: Dabrafenib will be taken twice a day for 28 consecutive days Trametinib will be taken once a day for 28 consecutive days PDR001 will be administered IV every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1550
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,470 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,010 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,269 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dabrafenib + Trametinib + PDR001 In Colorectal Cancer
Ryan B Corcoran 2018. "Dabrafenib + Trametinib + PDR001 In Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03668431.
~4 spots leftby Apr 2025
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