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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 one year
Awards & highlights
Study Summary
This trial is testing the combination of a new drug (CBP501) with cisplatin and nivolumab to treat patients with exocrine pancreatic cancer that has spread and has a low white blood cell count.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Three-month progression free survival rate (3M PFSR)
Secondary outcome measures
Confirmed and timepoint objective response rates (cORR/ORR)
Duration of responses (DoR)
Overall survival (OS)
+3 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 4: Cisplatin + NivolumabExperimental Treatment2 Interventions
Cisplatin 60mg/m2 will be administered as infusion and then Nivolumab 240mg will be administered.
Group II: Arm 3: CBP501 (25) + CisplatinExperimental Treatment2 Interventions
CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously.
Group III: Arm 2: CBP501 (16) + Cisplatin + NivolumabExperimental Treatment3 Interventions
CBP501 16mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.
Group IV: Arm 1: CBP501 (25) + Cisplatin + NivolumabExperimental Treatment3 Interventions
CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
CBP501 (25)
2021
Completed Phase 2
~40
CBP501 (16)
2021
Completed Phase 2
~40
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
CanBas Co. Ltd.Lead Sponsor
4 Previous Clinical Trials
359 Total Patients Enrolled
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