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KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Phase < 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
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 cycle 1 day 1 (c1d1) and cycle 3 day 1 (c3d1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. the duration of the infusion was 2 hours. one cycle=28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called KAZ954 alone and with other drugs to find the safest and most effective dose for patients with advanced cancer. The goal is to see if these treatments can help patients who haven't responded to standard therapies.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 (c1d1) and cycle 3 day 1 (c3d1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. the duration of the infusion was 2 hours. one cycle=28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 (c1d1) and cycle 3 day 1 (c3d1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. the duration of the infusion was 2 hours. one cycle=28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose intensity of study treatment
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of adverse events and serious adverse events during the on-treatment period
+1 more
Secondary study objectives
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of NIR178 and its metabolite NJI765
Area under the serum concentration-time curve from time zero to 14 days post dose (AUC0-14d) of KAZ954
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of PDR001
+13 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
73%
Diarrhoea
48%
Aspartate aminotransferase increased
43%
Alanine aminotransferase increased
27%
Decreased appetite
23%
Nausea
20%
Blood bilirubin increased
20%
Pyrexia
19%
Vomiting
19%
Fatigue
19%
Oedema peripheral
19%
Abdominal pain
17%
Pruritus
15%
Asthenia
14%
Constipation
13%
Anaemia
12%
Blood alkaline phosphatase increased
12%
Cough
12%
Abdominal pain upper
11%
Ascites
11%
Gamma-glutamyltransferase increased
10%
Dyspnoea
10%
Insomnia
9%
Abdominal distension
9%
Back pain
8%
Weight decreased
8%
Hyperphosphataemia
8%
Lipase increased
8%
Hypoalbuminaemia
8%
Headache
7%
Musculoskeletal pain
5%
Hyponatraemia
5%
Dry skin
5%
Hypertension
5%
Rash
4%
Dysgeusia
4%
Nasopharyngitis
4%
Procedural pain
4%
Productive cough
4%
Platelet count decreased
3%
Hepatic pain
3%
Blood creatine phosphokinase increased
3%
Myalgia
3%
Anxiety
3%
Hyperlipasaemia
3%
Gastrooesophageal reflux disease
3%
Dysphagia
3%
Dry mouth
3%
Rhinitis
3%
Chills
3%
Arthralgia
3%
Blood creatinine increased
3%
Hyperglycaemia
3%
Hypokalaemia
3%
Haemoptysis
2%
Abdominal discomfort
2%
Peripheral swelling
2%
Leukopenia
2%
Night sweats
2%
Hyperkalaemia
2%
Dizziness
2%
Musculoskeletal chest pain
2%
Epistaxis
2%
Pleural effusion
2%
Upper gastrointestinal haemorrhage
2%
Dyspepsia
2%
Melaena
2%
Bronchitis
2%
Jaundice
2%
Oesophageal varices haemorrhage
2%
Haematemesis
2%
Hyperbilirubinaemia
2%
Hypertriglyceridaemia
2%
Stomatitis
2%
Pain in extremity
2%
Hepatocellular injury
2%
Malaise
2%
Oedema
2%
Pain
2%
Duodenal ulcer
2%
Pneumonia
2%
Urinary tract infection
2%
Amylase increased
2%
C-reactive protein increased
2%
Transaminases increased
2%
Hypercalcaemia
2%
Hypophosphataemia
2%
Flank pain
2%
Muscle spasms
2%
Oropharyngeal pain
2%
Neutrophil count decreased
2%
Dysphonia
1%
Hypomagnesaemia
1%
Sinusitis
1%
Bleeding varicose vein
1%
Hypovolaemic shock
1%
Hyperthyroidism
1%
Hypoglycaemia
1%
Bronchostenosis
1%
Gastroenteritis
1%
Varicocele
1%
Rash macular
1%
Gastritis
1%
Liver carcinoma ruptured
1%
Paraparesis
1%
Hepatorenal syndrome
1%
Peripheral sensory neuropathy
1%
Female genital tract fistula
1%
Toothache
1%
Pulmonary embolism
1%
Oesophageal stenosis
1%
Venous thrombosis
1%
Hepatic cirrhosis
1%
Vertigo
1%
Duodenal obstruction
1%
Angular cheilitis
1%
Bone contusion
1%
Sleep disorder
1%
Pneumonitis
1%
Haematoma
1%
Spinal cord compression
1%
Spinal pain
1%
Biloma
1%
Herpes zoster
1%
Calculus urinary
1%
Atelectasis
1%
Thrombocytopenia
1%
Hepatic function abnormal
1%
Malnutrition
1%
Gastric varices
1%
Abdominal tenderness
1%
Groin pain
1%
Dyspnoea exertional
1%
Confusional state
1%
Blood albumin decreased
1%
Gastrointestinal sounds abnormal
1%
Gastrointestinal haemorrhage
1%
Bilirubin conjugated increased
1%
Haemorrhoidal haemorrhage
1%
Acute kidney injury
1%
Prothrombin time prolonged
1%
Cancer pain
1%
Rash pustular
1%
Oesophageal ulcer
1%
Hyperuricaemia
1%
Tumour associated fever
1%
Folliculitis
1%
Hepatomegaly
1%
Cholangitis
1%
Varices oesophageal
1%
Animal bite
1%
Haemorrhage intracranial
1%
Palpitations
1%
General physical health deterioration
1%
Hernia
1%
Acute coronary syndrome
1%
Coronary artery disease
1%
Haemorrhoids
1%
Rash maculo-papular
1%
Cholestasis
1%
Hepatic haematoma
1%
Pyelonephritis acute
1%
Varicella
1%
Cerebrovascular accident
1%
Dysarthria
1%
Paraesthesia
1%
Paraplegia
1%
Urinary retention
1%
Aneurysm
1%
Hyperglobulinaemia
1%
Chest discomfort
1%
Herpes virus infection
1%
Tinea cruris
1%
Activated partial thromboplastin time prolonged
1%
Blood cholesterol increased
1%
Blood phosphorus decreased
1%
Haemoglobin decreased
1%
Osteoporosis
1%
Scrotal oedema
1%
Carotid artery stenosis
1%
Lymphopenia
1%
Jaundice cholestatic
1%
Hot flush
1%
Tumour thrombosis
1%
Candida infection
1%
Visual field defect
1%
Gait disturbance
1%
Depression
1%
Multiple organ dysfunction syndrome
1%
Lung infection
1%
Bronchial obstruction
1%
Vena cava thrombosis
1%
Inferior vena caval occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients
Phase I: 80 mg Fed
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 120 mg Fasted
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase I: FGF401 80 mg + PDR001 300 mg
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 120 mg + PDR001 300 mg
All Patients of Combination Dose

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 DExperimental Treatment2 Interventions
KAZ954 + NZV930
Group II: Arm CExperimental Treatment2 Interventions
KAZ954 + NIR178
Group III: Arm BExperimental Treatment2 Interventions
KAZ954 + PDR001
Group IV: Arm AExperimental Treatment1 Intervention
KAZ954
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2890

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,610 Total Patients Enrolled

Media Library

KAZ954 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04237649 — Phase < 1
Solid Tumors Research Study Groups: Arm B, Arm D, Arm A, Arm C
Solid Tumors Clinical Trial 2023: KAZ954 Highlights & Side Effects. Trial Name: NCT04237649 — Phase < 1
KAZ954 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04237649 — Phase < 1
~13 spots leftby Dec 2025
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