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Tyrosine Kinase Inhibitor
Cabozantinib + Cetuximab for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Loren Michel, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capability of understanding and complying with the protocol requirements and signed the informed consent document
Age ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety of cabozantinib combined with cetuximab to treat HNSCC.
Who is the study for?
Adults with incurable head and neck squamous cell carcinoma, who have measurable disease and are in good physical condition (ECOG 0 or 1). They must not be pregnant, have had certain treatments recently, or have serious health issues that could interfere with the trial. Participants should agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing different doses of cabozantinib combined with cetuximab to see how safe they are for treating recurrent or metastatic head and neck cancer. The effects on patients at these varying doses will be closely monitored.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, bleeding issues including GI bleeding or coughing up blood, problems swallowing tablets, significant fatigue due to anemia or other blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study requirements and have signed the consent form.
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I am 18 years old or older.
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My blood tests and organ functions are within normal ranges.
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I am not pregnant and can become pregnant.
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I am fully active or can carry out light work.
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My cancer has spread or returned and cannot be removed by surgery.
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My cancer is a type of squamous cell carcinoma located in the head or neck.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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)
Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cabozantinib in Combination With CetuximabExperimental Treatment2 Interventions
Cetuximab will be administered at 500 mg/m^2 intravenously every other week. Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,602 Total Patients Enrolled
Loren Michel, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study requirements and have signed the consent form.I am 18 years old or older.I have received more than 70 Gy of radiation to my neck or head in the last 2 months.I have recently had specific cancer treatments.I am currently taking blood thinners.My tumor is growing into or around major blood vessels.My brain metastases are treated and stable.I have not had major surgery recently.I have symptoms of an underactive thyroid.I have received chemotherapy for cancer that has spread.I need ongoing treatment with strong CYP3A4 inducers.I have recovered from side effects of previous treatments, with only mild symptoms remaining.My blood tests and organ functions are within normal ranges.I am not pregnant and can become pregnant.My liver function is significantly impaired.I am fully active or can carry out light work.I have had serious bleeding issues recently.I do not have any severe, uncontrolled illnesses.All my cancer sites were checked within the last 28 days.I have a serious wound, ulcer, or bone fracture that isn't healing.I have not had radiation therapy recently.My cancer has spread or returned and cannot be removed by surgery.I have been treated with cabozantinib before.I have had cancer other than my current one in the last 5 years, with some exceptions.My cancer is a type of squamous cell carcinoma located in the head or neck.I cannot swallow whole pills.My tumor has spread to my gastrointestinal tract or airways recently.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib in Combination With Cetuximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Cabozantinib for medical use?
"Cabozantinib's safety has been evaluated to the extent that it received a score of 1 on a scale from 1 to 3. This is because this phase one trial only provides limited evidence for its efficacy and security."
Answered by AI
In how many distinct locations is this clinical trial taking place?
"Nine sites are presently participating in this clinical trial, including Memorial Sloan Kettering Monmouth (Middletown), Lehigh Valley Health Network (Allentown) and Memorial Sloan Kettering Westchester (Harrison). Several other medical centres have joined the study as well."
Answered by AI
How often has Cabozantinib been utilized in past experiments?
"Currently, there are 229 active clinical trials that focus on Cabozantinib with 41 of them being in the final phase. Most tests take place in Dresden, Arizona; however a total of 12373 sites worldwide provide testing for this drug."
Answered by AI
How many participants are undergoing treatment as part of this clinical experiment?
"This trial requires 24 eligible patients to participate, with recruitment taking place at sites such as Memorial Sloan Kettering Monmouth in Middletown, Pennsylvania and Lehigh Valley Health Network in Allentown, New york."
Answered by AI
What does Cabozantinib generally aim to treat?
"Patients who have already undergone anti-vegf treatment, present with metastatic squamous cell carcinoma of the head and neck (hnscc), or are deemed at a higher risk for developing cancer can benefit from Cabozantinib."
Answered by AI
Is enrollment currently open for this trial?
"Clinicaltrials.gov reveals that the trial is actively recruiting patients, with its initial posting on September 7th 2018 and most recent update being October 14th 2022."
Answered by AI
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