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Monoclonal Antibodies

INC280 for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by SCRI Development Innovations, LLC
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 every 8 weeks up to 6 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat people with GBM who have progressed after other treatments or who can't have surgery.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma
  • Colorectal Cancer
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks up to 6 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
Maximum Tolerated Dose (MTD) of INC280
Secondary outcome measures
Overall Response Rate
Progression-free Survival

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT02019693
80%
Nausea
75%
Creatinine increased
60%
Diarrhea
60%
Dyspepsia
55%
Lymphocyte count decreased
55%
Fatigue
50%
Pain
50%
Hypoalbuminemia
45%
Hypophosphatemia
45%
Edema limbs
35%
Lipase increased
35%
Headache
30%
Hyponatremia
30%
Serum amylase increased
30%
Anemia
30%
Chills
30%
Dizziness
30%
Platelet count decreased
25%
Hyperglycemia
25%
Hypotension
25%
Myalgia
25%
Abdominal pain
25%
Alanine aminotransferase increased
25%
Anxiety
25%
Aspartate aminotransferase increased
25%
Cough
25%
Sinus bradycardia
20%
Weight gain
20%
Hypertriglyceridemia
20%
White blood cell decreased
20%
Hypocalcemia
20%
Hyperuricemia
20%
Constipation
20%
Fever
15%
Rash acneiform
15%
Nasal congestion
15%
Vomiting
15%
Insomnia
15%
Anorexia
15%
Back pain
15%
Proteinuria
15%
Pruritus
10%
Hyperparathyroidism
10%
Hypoglycemia
10%
Hypothyroidism
10%
Memory impairment
10%
Pain in extremity
10%
CPK increased
10%
Alkaline phosphatase increased
10%
Blurred vision
10%
Chest wall pain
10%
Cholesterol high
10%
Dry skin
10%
Dyspnea
10%
Gastroesophageal reflux disease
10%
Genital edema
10%
Neutrophil count decreased
10%
Pleural effusion
5%
Hypertension
5%
Skin infection
5%
Skin and subcutaneous tissue disorders - Other, Skin lesions
5%
General disorders and administration site conditions - Other, Sweats
5%
Hypermagnesemia
5%
Hypokalemia
5%
Hypomagnesemia
5%
Localized edema
5%
Palmar-plantar erythrodysesthesia syndrome
5%
Penile pain
5%
Peripheral sensory neuropathy
5%
Urinary frequency
5%
Urinary incontinence
5%
Urticaria
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Thyroid mass
5%
Atrial fibrillation
5%
Syncope
5%
Dry mouth
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Benign Thyroid Neoplasm
5%
Nervous system disorders - Other, numbness sinus area
5%
Spinal fracture
5%
Toothache
5%
Wheezing
5%
Allergic rhinitis
5%
Arthralgia
5%
Ataxia
5%
Blood bilirubin increased
5%
Burn
5%
Chest pain - cardiac
5%
Depression
5%
Dry eye
5%
Dysgeusia
5%
Edema face
5%
Eye disorders - Other, Left eye subconjunctival hemorrhage
5%
Eye disorders - Other, Right eye stye
5%
Flashing lights
5%
Flatulence
5%
Flu like symptoms
5%
Gastritis
5%
Gastrointestinal disorders - Other, diverticulosis
5%
Gynecomastia
5%
Hemoglobinuria
5%
Hoarseness
5%
Irritability
5%
Laryngeal inflammation
5%
Neuralgia
5%
Non-cardiac chest pain
5%
Oral dysesthesia
5%
Oral pain
5%
Palpitations
5%
Photophobia
5%
Rash maculo-papular
5%
Skin and subcutaneous tissue disorders - Other, Seborrheic keratosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Capmatinib (INC280)

Trial Design

1Treatment groups
Experimental Treatment
Group I: INC280 + BevacizumabExperimental Treatment2 Interventions
Dose Escalation: 18 GBM patients received bevacizumab 10 mg/kg intravenously (IV) once every 2 weeks in combination with INC280 given by mouth (PO) starting at 100 mg twice daily and escalating on a 3+3 escalation pattern until the maximum tolerated dose (MTD) was determined. Dose Expansion: Up to 45 GBM patients enrolled in 3 Cohorts: Cohort A: 20 GBM patients - progressed during or after standard 1st-line therapy; Cohort B: 15 GBM patients - progressed during or after 2nd-line bevacizumab therapy; Cohort C: 10 unresectable GBM patients. INC280: PO twice daily at the MTD. Bevacizumab: 10 mg/kg IV once every 2 weeks for Cohorts A and B; 15 mg/kg IV every 4 weeks for Cohort C Treatment cycles will be repeated every 28 days (4 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INC280
2014
Completed Phase 2
~1020
bevacizumab
2002
Completed Phase 3
~3360

Find a Location

Who is running the clinical trial?

SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,498 Total Patients Enrolled
3 Trials studying Glioblastoma
203 Patients Enrolled for Glioblastoma
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,726 Total Patients Enrolled
12 Trials studying Glioblastoma
696 Patients Enrolled for Glioblastoma
Kent C. Shih, M.D.Study ChairSCRI Development Innovations, LLC

Frequently Asked Questions

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

Are there any openings for participants in this clinical trial currently?

"This research has already ceased recruitment, as the first posting was published on September 22nd 2015 with a final update made to it on November 1st 2022. However, if you are seeking active clinical studies that involve gliosarcoma or INC280 there are currently 1388 and 369 trials respectively recruiting patients."

Answered by AI

Could you please elaborate on other scientific endeavors that have involved INC280?

"In 2004, the first trial of INC280 was conducted at Memoral Sloan Kettering Basking Ridge (Follow Up Only). Subsequently, 1020 studies have been completed. Currently, 369 research initiatives are underway; with a significant portion being in Kansas City, Missouri."

Answered by AI

How many healthcare centers are carrying out this clinical experiment?

"Patients can be enrolled in this research project at HCA Midwest - Kansas City, Sarah Cannon Research Institute at HealthONE and Yale School of Medicine as well as 5 additional medical facilities."

Answered by AI

Can you explain what conditions INC280 is typically administered to treat?

"INC280 is frequently prescribed for the treatment of malignant neoplasms. Moreover, it also has therapeutic potential in recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer that was initially surgically removed, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many participants are a part of this research project?

"Unfortunately, this experiment is not presently looking for volunteers. This clinical trial was first published on September 22nd 2015 and last modified on November 1st 2022. If you are interested in alternative studies, there are 1388 trials enrolling patients with gliosarcoma and 369 research projects recruiting participants for INC280 treatments."

Answered by AI

What potential risks are associated with INC280 when used therapeutically?

"Due to the early stage of this trial, there is limited data regarding INC280's efficacy and safety. Hence, we have rated it a 1 on our scale from one to three."

Answered by AI
~7 spots leftby Mar 2025