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Tyrosine Kinase Inhibitor

Cabozantinib for Neuroendocrine Carcinoma

Phase 2
Waitlist Available
Led By Robert Haddad, MD
Research Sponsored by Dana-Farber Cancer Institute
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 3 months
Awards & highlights

Study Summary

This trial is testing whether a drug called cabozantinib may help people with a certain type of skin cancer that has come back or spread after other treatments.

Eligible Conditions
  • Neuroendocrine Carcinoma
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
3-Month Disease Control Rate (DCR)
Secondary outcome measures
3-Month Overall Survival (OS) Rate
3-month Progression-free Survival (PFS)
Grade 3-5 Treatment-Related Adverse Event (AE) Rate

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
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%
BILIRUBIN INCREASED
14%
DIZZINESS
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%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Peripheral Sensory Neuropathy
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
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: CabozantinibExperimental Treatment1 Intervention
Cabozantinib 60 mg given orally daily for 28 days (4 weeks) each cycle. Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,972 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,543 Total Patients Enrolled
Robert Haddad, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
1,197 Total Patients Enrolled

Frequently Asked Questions

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

What is the history of Cabozantinib in human clinical trials?

"As of now, there are 116 ongoing clinical trials evaluating the effects of Cabozantinib. Out of these studies, 13 are in Phase 3. Most investigations for Cabozantinib are taking place in Cordoba and Calabria; however, there are 7151 total research sites worldwide."

Answered by AI

How many people are participating in this clinical trial?

"This particular trial is not recruiting patients at the moment, as noted by its last edit date of July 13th, 2022. However, there are 2684 other trials for cancer of the skin and 116 studies for Cabozantinib that are currently looking for participants."

Answered by AI

What conditions does Cabozantinib commonly help alleviate?

"While typically used to treat patients that have already undergone anti-VEGF therapy, cabozantinib has also shown efficacy in treating advanced renal cell carcinoma, adrenal medulla tumours, and high risk patients."

Answered by AI

Are there any short-term side effects of Cabozantinib?

"Because there is only data supporting Cabozantinib's safety and none for efficacy, it received a score of 2."

Answered by AI

To your knowledge, has a study like this been conducted before?

"According to our records, there are 116 clinical trials involving Cabozantinib that are currently active in 46 countries and 1375 cities. The first such trial began in 2012, 86 patients participated, and it completed Phase 2 drug approval. Since then, 55 more trials have been conducted."

Answered by AI

Are there any available appointments for this research project?

"This study is not recruiting patients at the moment. Per information found on clinicaltrials.gov, this trial was originally posted on 01/01/2014 and was last updated 07/13/2022. If you are looking for other studies, there are 2684 trials concerning cancer of the skin that are actively recruiting participants and 116 trials involving Cabozantinib currently have open recruitment."

Answered by AI
Recent research and studies
The OncologistJournal
Cabozantinib in Patients with Advanced Merkel Cell Carcinoma
Rabinowits, Guilherme, Cecilia Lezcano, Paul J. Catalano, Patricia McHugh, Hailey Becker, Megan M. Reilly, Julian Huang, et al.. 2018. “Cabozantinib in Patients with Advanced Merkel Cell Carcinoma”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.2017-0552.
clinicaltrials.govStudy
Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma
Robert Haddad, MD 2014. "Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02036476.
~1 spots leftby Apr 2025
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