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KAZ954 for 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 36 months
Awards & highlights

Study Summary

This trial is testing different therapies to see if they are effective and safe in patients with advanced cancer.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensity of study treatment
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of adverse events and serious adverse events
+1 more
Secondary outcome measures
Assess the correlation between PD-L1 expression level in tumor using a validated assay and response to KAZ954 and in combo with PDR001, NIR178 or NZV930
Disease Control Rate (DCR)
Overall Response Rate (ORR)
+12 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

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
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,273 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to enlist in this research study at the present moment?

"According to clinicaltrials.gov, this research study is actively recruiting participants with the original post date of February 20th 2020 and most recent update on June 7th 2022."

Answered by AI

Could you enumerate the tests that have been carried out using KAZ954?

"Presently, 27 clinical trials involving KAZ954 are active with 1 of them at the Phase 3 level. These studies have enrolled participants from across 508 sites in New york and other locations around the world."

Answered by AI

How many people have enrolled in this research project?

"Affirmative. According to information on clinicaltrials.gov, this medical trial was first published in February 2020 and recently updated in June 2022 is actively searching for patients. A total of 145 participants from 6 different sites are being sought out for the study."

Answered by AI

Is this investigation completely unprecedented?

"At the time of writing, 27 clinical trials for KAZ954 are currently taking place. 35 nations and 122 cities are participating in these tests which were initiated by Novartis Pharmaceuticals back in 2011 with 185 volunteers who took part in Phase 1 drug approval analyses. Since then, 21 experiments have been concluded."

Answered by AI

Are there a plethora of sites operating this trial in North America?

"To participate in this study, patients can visit the University of Texas MD Anderson Cancer Center in Houston, or UCLA Medical Centre in Los Angeles. For those on the East coast, Yale Cancer Center is offering enrolment. Furthermore there are 6 other medical sites that are taking part as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
2020. "KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04237649.
~15 spots leftby Apr 2025
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