capmatinib for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Leuven, BelgiumSolid Tumorscapmatinib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is to study the long-term safety of a drug called capmatinib, which is given to patients who are judged to benefit from the treatment.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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KAZ954
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PDR001
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Capmatinib

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Day 1 up to 10 years, assessed every 12 weeks

Year 10
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
KAZ954
1
PDR001
1
Capmatinib

Side Effects for

Run-in Part: Capmatinib + Spartalizumab
39%Nausea
28%Diarrhoea
28%Blood creatinine increased
28%Vomiting
28%Dyspnoea
22%Pyrexia
22%Asthenia
22%Fatigue
22%Oedema peripheral
17%Weight decreased
11%Pleural effusion
11%Decreased appetite
11%Constipation
11%Lipase increased
11%Pruritus
11%Chest pain
11%Dysphagia
11%Anaemia
11%Alanine aminotransferase increased
11%Anxiety
11%Lymphocyte count decreased
11%Aspartate aminotransferase increased
11%C-reactive protein increased
6%Haemoptysis
6%Productive cough
6%General physical health deterioration
6%Cancer pain
6%Herpes zoster
6%Osteomyelitis
6%Depression
6%Stress cardiomyopathy
6%Abdominal pain
6%Cough
6%Blood magnesium decreased
6%Dehydration
6%Hyperglycaemia
6%Hyperhidrosis
6%Lethargy
6%Gamma-glutamyltransferase increased
6%Hypotension
6%Arthralgia
6%Hypoalbuminaemia
6%Pain
6%Dysgeusia
6%Pneumonia
6%Confusional state
6%Dizziness
6%Pain in extremity
6%Dyspnoea exertional
6%Dyspepsia
6%Dry mouth
6%Stomatitis
6%Cardiac failure congestive
6%Cheilitis
6%Ventricular arrhythmia
6%Deep vein thrombosis
6%Respiratory failure
6%Eyelid oedema
6%Drug hypersensitivity
6%Respiratory tract infection
6%Bronchial obstruction
6%Abdominal infection
6%Anaphylactic reaction
6%Pericardial effusion
6%Sleep disorder
6%Renal pain
6%Hypomagnesaemia
6%Axillary pain
6%Muscle spasms
6%Dysphonia
6%Blood alkaline phosphatase increased
6%Creatinine renal clearance decreased
6%Somnolence
6%Amylase increased
6%Musculoskeletal chest pain
6%Headache
6%Nipple pain
6%Rash macular
6%Bronchospasm
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03647488) in the Run-in Part: Capmatinib + Spartalizumab ARM group. Side effects include: Nausea with 39%, Diarrhoea with 28%, Blood creatinine increased with 28%, Vomiting with 28%, Dyspnoea with 28%.

Trial Design

7 Treatment Groups

INC280/Gefitinib
1 of 7
Capmatinib + Gefitinib
1 of 7
INC280/EGF816
1 of 7
Capmatinib
1 of 7
Capmatinib + Nazartinib
1 of 7
Capmatinib + Osimertinib
1 of 7
INC280
1 of 7

Active Control

Experimental Treatment

40 Total Participants · 7 Treatment Groups

Primary Treatment: capmatinib · No Placebo Group · Phase 2

Capmatinib + GefitinibExperimental Group · 2 Interventions: Capmatinib, Gefitinib · Intervention Types: Drug, Drug
INC280/EGF816Experimental Group · 2 Interventions: Nazartinib, capmatinib · Intervention Types: Drug, Drug
Capmatinib
Drug
Experimental Group · 1 Intervention: Capmatinib · Intervention Types: Drug
Capmatinib + NazartinibExperimental Group · 2 Interventions: Capmatinib, Nazartinib · Intervention Types: Drug, Drug
Capmatinib + OsimertinibExperimental Group · 2 Interventions: Osimertinib, Capmatinib · Intervention Types: Drug, Drug
INC280
Drug
Experimental Group · 1 Intervention: capmatinib · Intervention Types: Drug
INC280/GefitinibActiveComparator Group · 2 Interventions: Gefitinib, capmatinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~770
Capmatinib
2021
Completed Phase 2
~290
Gefitinib
FDA approved
Capmatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to 10 years, assessed every 12 weeks

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,738 Previous Clinical Trials
3,544,174 Total Patients Enrolled
Toni Wozniak, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently benefiting from the study treatment according to the investigator.
References

Frequently Asked Questions

How many people total will be taking part in this clinical trial?

"That is correct. The clinical trial, which was first posted on July 4th 2017 and last edited on October 5th 2020, appears to be actively recruiting patients. Currently, the study needs 40 individuals between its 2 planned locations." - Anonymous Online Contributor

Unverified Answer

When will capmatinib be available for public use?

"Capmatinib's safety is supported by some data, but as this is only a Phase 2 trial, there is no clinical evidence yet of the medication's efficacy. Therefore, we gave it a score of 2." - Anonymous Online Contributor

Unverified Answer

Are patients being enrolled in this clinical trial at present?

"The clinical trial is actively recruiting patients, as shown by the updated information on clinicaltrials.gov. The trial was originally posted on 7/4/2017, and the most recent update was 10/5/2022. The study requires 40 patients from 2 locations." - Anonymous Online Contributor

Unverified Answer

Are there other similar medical studies that have tested the effects of capmatinib?

"44 clinical trials are investigating the efficacy of capmatinib with 17 of them in Phase 3. Most of these medical studies are taking place in Chuo-Ku, Tokyo; however, there are 873 research sites for this drug globally." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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