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Cisplatin for Pancreatic Cancer

Phase 2

Waitlist Available

Research Sponsored by CanBas Co. Ltd.

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

No Placebo-Only Group

Summary

This trial tests combinations of three drugs to treat advanced pancreatic cancer. It targets patients with advanced cancer and specific blood cell counts. The drugs work by killing cancer cells and helping the immune system fight the cancer. Gemcitabine has been a cornerstone in the treatment of advanced pancreatic cancer, often used in combination with other drugs to improve efficacy.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Three-month progression free survival rate (3M PFSR)

Secondary study objectives

Confirmed and timepoint objective response rates (cORR/ORR)

Duration of responses (DoR)

Overall survival (OS)

+3 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

CBP501 (25)

2021

Completed Phase 2

~40