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Kinase Inhibitor
derazantinib for Intrahepatic Cholangiocarcinoma (FIDES-01 Trial)
Phase 2
Waitlist Available
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Signed written informed consent granted prior to initiation of any study-specific procedures
Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose and up to 54 months
Awards & highlights
FIDES-01 Trial Summary
This trial will study the effectiveness of derazantinib, a new drug, in treating subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors have FGFR2 gene mutations or amplifications.
Eligible Conditions
- Intrahepatic Cholangiocarcinoma
- Hepatocellular-Cholangiocarcinoma
FIDES-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIDES-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose and up to 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose and up to 54 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Substudy 1: Objective Response Rate (ORR)
Substudy 2: Progression Free Survival at 3 Months (PFS 3)
Secondary outcome measures
Duration of Response (DoR)
Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs)
Overall Survival (OS)
+2 moreSide effects data
From 2022 Phase 2 trial • 148 Patients • NCT0323031841%
Nausea
39%
Dry mouth
34%
Vomiting
32%
Diarrhoea
30%
Alanine aminotransferase increased
30%
Aspartate aminotransferase increased
30%
Fatigue
27%
Hyperphosphataemia
25%
Dysgeusia
20%
Decreased appetite
20%
Blood alkaline phosphatase increased
18%
Constipation
16%
Blood creatinine increased
16%
Cough
16%
Dry eye
14%
Vision blurred
14%
Weight decreased
14%
Anaemia
14%
Alopecia
14%
Abdominal pain
14%
Asthenia
11%
Platelet count decreased
11%
Headache
11%
Xerophthalmia
11%
Hypertension
9%
Hyponatraemia
9%
Oedema peripheral
7%
Visual impairment
7%
Dizziness
7%
Disease progression
7%
Epistaxis
7%
Dry skin
7%
White blood cell count decreased
7%
Nail discolouration
7%
Keratitis
7%
Neutrophil count decreased
7%
Hypercalcaemia
7%
Peripheral sensory neuropathy
7%
Mucosal inflammation
7%
Abdominal distension
5%
Dyspnoea
5%
Dehydration
5%
Dyspepsia
5%
Anxiety
5%
Hypoalbuminaemia
5%
Vitamin D deficiency
5%
Blood phosphorus increased
5%
Urinary tract infection
5%
Pyrexia
2%
Tremor
2%
Depression
2%
Death
2%
Device occlusion
2%
Cornea verticillata
2%
COVID-19 pneumonia
2%
Arthritis bacterial
2%
Abdominal pain upper
2%
Presyncope
2%
Paraesthesia
2%
Pleural effusion
2%
Oesophageal varices haemorrhage
2%
Intervertebral discitis
2%
Liver transplant
2%
Thrombocytopenia
2%
Pulmonary embolism
2%
General physical health deterioration
2%
Bundle branch block left
2%
Oropharyngeal pain
2%
Acute kidney injury
2%
Hypoxia
2%
Gastrooesophageal reflux disease
2%
Arthralgia
2%
Nephrolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Substudy 2
Substudy 1
FIDES-01 Trial Design
1Treatment groups
Experimental Treatment
Group I: derazantinibExperimental Treatment1 Intervention
Oral administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
derazantinib
2017
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Basilea PharmaceuticaLead Sponsor
39 Previous Clinical Trials
8,909 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
Manuel Häckl, MDStudy DirectorBasilea Pharmaceutica International Ltd, Allschwil
3 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
Miryana Dimova-Dobreva, MDStudy DirectorBasilea Pharmaceutica International Ltd
1 Previous Clinical Trials
1 Trials studying Intrahepatic Cholangiocarcinoma
Frequently Asked Questions
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