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Gamma-Secretase Inhibitor
PF-03084014 for Desmoid Tumors
Phase 2
Waitlist Available
Led By Geraldine H O'Sullivan Coyne, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 at baseline prior to drug administration and at least every 6 cycles of drug (18 weeks) up to 20 months of treatment.
Awards & highlights
Study Summary
This trial is testing a drug to treat desmoid tumors, which are rare, slow-growing tumors. The drug is given orally twice a day, and the trial will assess the response rate to the drug, as well as side effects. Tumor biopsies will be done to assess the drug's effect on the tumors and to look for genetic mutations associated with the disease.
Eligible Conditions
- Desmoid Tumors
- Aggressive Fibromatosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline prior to drug administration and at least every 6 cycles of drug (18 weeks) up to 20 months of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline prior to drug administration and at least every 6 cycles of drug (18 weeks) up to 20 months of treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a Complete Response (CR) + Partial Response (PR)
Secondary outcome measures
Mean MD Anderson Symptom Inventory Scores After Treatment
Number of Participants With Serious and Non-serious Adverse Events
Number of Participants With Somatic or Germline Mutations Identified in Adenomatous Polyposis Coli Gene (APC) or Catenin Beta-1 (CTNNB1) Genes
Side effects data
From 2023 Phase 2 trial • 17 Patients • NCT0198155188%
Diarrhea
76%
Headache
76%
Hypophosphatemia
76%
Nausea
71%
Aspartate aminotransferase increased
71%
Lymphocyte count decreased
59%
Rash maculo-papular
53%
Fatigue
53%
Alanine aminotransferase increased
53%
Anemia
53%
Hypocalcemia
53%
Hypokalemia
47%
Hyponatremia
47%
Hot flashes
47%
Pain
47%
Abdominal pain
41%
Rash acneiform
41%
Hypertension
41%
Skin infection
41%
White blood cell decreased
41%
Dry mouth
35%
Vomiting
35%
Myalgia
35%
Fever
35%
Flu like symptoms
35%
Cough
35%
Mucositis oral
35%
Edema limbs
29%
Constipation
29%
Bruising
29%
Alkaline phosphatase increased
29%
Upper respiratory infection
29%
Back pain
29%
Pain in extremity
29%
Hypoalbuminemia
24%
Irregular menstruation
24%
Nasal congestion
24%
Skin and subcutaneous tissue disorders - Other, folliculitis
24%
Epistaxis
24%
Fracture
24%
Activated partial thromboplastin time prolonged
24%
Peripheral sensory neuropathy
24%
Chills
24%
Hyperhidrosis
24%
Memory impairment
24%
Platelet count decreased
24%
Sore throat
24%
Weight loss
24%
Dizziness
24%
Dry skin
18%
Hyperkalemia
18%
Creatinine increased
18%
Infections and infestations - Other, upper respiratory infection
18%
Libido decreased
18%
Menorrhagia
18%
Gastroesophageal reflux disease
18%
Blurred vision
18%
Anorexia
18%
Blood bilirubin increased
18%
Hypercalcemia
18%
Hyperglycemia
18%
Reproductive system and breast disorders - Other, amenorrhea
18%
Anxiety
18%
Neutrophil count decreased
18%
Insomnia
18%
Dehydration
18%
Depression
18%
Dysgeusia
12%
Pharyngitis
12%
Postnasal drip
12%
Vertigo
12%
Weight gain
12%
Productive cough
12%
Sinusitis
12%
Pruritus
12%
Flatulence
12%
Arthralgia
12%
Palpitations
12%
Paresthesia
12%
Thromboembolic event
12%
Urinary tract infection
12%
Allergic rhinitis
12%
Alopecia
12%
Hypermagnesemia
12%
Hypernatremia
12%
Vaginal infection
12%
Skin hyperpigmentation
12%
Cognitive disturbance
12%
Dysmenorrhea
12%
Dyspnea
12%
Ear and labyrinth disorders - Other, eustachian tube dysfunction
6%
Oral hemorrhage
6%
Gingival pain
6%
Gastrointestinal disorders - Other, abdominal cramping
6%
Musculoskeletal and connective tissue disorder - Other, stress injury
6%
Hip fracture
6%
Hirsutism
6%
Metabolism and nutrition disorders - Other, hyperphosphatemia
6%
Musculoskeletal and connective tissue disorder - Other, right deltoid muscle tenderness
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, R paraspinal form tumor
6%
Hypomagnesemia
6%
Injury, poisoning and procedural complications - Other, injury, abdomen contusion
6%
Infections and infestations - Other, rhinitis infective
6%
Infections and infestations - Other, viral gastroenteritis
6%
Postoperative hemorrhage
6%
Reproductive system and breast disorders - Other, menstruation
6%
Skin and subcutaneous tissue disorders - Other, skin lesions
6%
Infections and infestations - Other, fungal infection (ear)
6%
Vaginal dryness
6%
Infections and infestations - Other, oral infections
6%
Infusion site extravasation
6%
Skin and subcutaneous tissue disorders - Other, small hard lump/Rt upper thigh
6%
Infections and infestations - Other, sinus infection
6%
Injury, poisoning and procedural complications - Other, injury, swollen mouth
6%
Reproductive system and breast disorders - Other, elevated LH
6%
Seizure
6%
Supraventricular tachycardia
6%
Infusion related reaction
6%
Investigations - Other, hypophosphatemia
6%
Psychiatric disorders - Other, Mood swings
6%
Injection site reaction
6%
Laryngitis
6%
Joint effusion
6%
Skin and subcutaneous tissue disorders - Other, left groin cystic lesion
6%
Skin and subcutaneous tissue disorders - Other, cyst
6%
Oral pain
6%
Renal and urinary disorders - Other, kidney stones
6%
Respiratory, thoracic and mediastinal disorders - Other, sinus congestion
6%
Skin and subcutaneous tissue disorders - Other, skin keratosis
6%
Periodontal disease
6%
Blood gonadotrophin abnormal
6%
Concentration impairment
6%
Enterocolitis
6%
Reproductive system and breast disorders - Other, elevated FSH
6%
Reproductive system and breast disorders - Other, genital infection
6%
Vaginal pain
6%
Electrocardiogram QT corrected interval prolonged
6%
Gastrointestinal disorders - Other, abdominal discomfort
6%
Gastrointestinal disorders - Other, gastroenteritis
6%
Hematoma
6%
Confusion
6%
Hematuria
6%
Stroke
6%
Atrial fibrillation
6%
Bronchial infection
6%
Bullous dermatitis
6%
Floaters
6%
Endocrine disorders - Other, elevated glucose level
6%
Erythema multiforme
6%
Eye disorders - Other, eye injury
6%
Eye disorders - Other, left eye swelling & discharge
6%
Cardiac disorders - Other, potential murmur/"whooshing"
6%
Conjunctivitis
6%
Cystitis noninfective
6%
Gastrointestinal disorders - Other, canker sores
6%
Hemoglobin increased
6%
Hemorrhoids
6%
Injury, poisoning and procedural complications - Other, specify
6%
Surgical and medical procedures - Other, hysterectomy
6%
Vaginal inflammation
6%
Arthritis
6%
Eye disorders - Other, visual disturbance
6%
Eye disorders - Other, exopthalmos bilateral
6%
Hoarseness
6%
Lung infection
6%
Musculoskeletal and connective tissue disorder - Other, tendinitis left groin/thigh
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, cyst
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, popliteal cysts
6%
Neoplasms benign, malignant and unspecified
6%
Pain of skin
6%
Pelvic pain
6%
Reproductive system and breast disorders - Other, breast tenderness
6%
Reproductive system and breast disorders - Other, R breat lump
6%
Respiratory, thoracic and mediastinal disorders - Other, cold
6%
Respiratory, thoracic and mediastinal disorders - Other, dry nasal passages
6%
Respiratory, thoracic and mediastinal disorders - Other, pneumonia
6%
Sinus tachycardia
6%
Surgical and medical procedures - Other, esophageal dilation
6%
Tinnitus
6%
Urinary frequency
6%
Urticaria
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, squamous cell carcinoma
6%
Amnesia
6%
Bloating
6%
Chest wall pain
6%
Eye disorders - Other, macular degeneration - left eye
6%
Eye disorders - Other, vision changes
6%
Musculoskeletal and connective tissue disorder - Other, tendinitis
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, rt groin area
6%
Nervous system disorders - Other, lightheadedness
6%
Non-cardiac chest pain
6%
Osteoporosis
6%
Renal and urinary disorders - Other, elevated BUN
6%
Surgical and medical procedures - Other, splenectomy
6%
Watering eyes
6%
Lip infection
6%
Lymphocyte count increased
6%
Malaise
6%
Middle ear inflammation
6%
Musculoskeletal and connective tissue disorder - Other, bone spur
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, cyst - right arm
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
6%
Tooth infection
6%
Allergic reaction
6%
Bronchospasm
6%
Facial pain
6%
Nail infection
6%
Pleural effusion
6%
Portal vein thrombosis
6%
Reproductive system and breast disorders - Other, menstrual spotting
6%
Skin and subcutaneous tissue disorders - Other, subcutaneous cysts
6%
Skin ulceration
6%
Soft tissue necrosis upper limb
6%
Stomach pain
6%
Wheezing
6%
Wound infection
6%
Psychiatric disorders - Other, Dreams
6%
Dry eye
6%
Hypoglycemia
6%
Cholesterol high
6%
Dyspepsia
6%
Dysphagia
6%
Ear pain
6%
Edema trunk
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis
Trial Design
1Treatment groups
Experimental Treatment
Group I: PF-03084014 in Desmoid Tumors/Aggressive FibromatosisExperimental Treatment1 Intervention
PF-03084014 will be administered orally at 150 mg twice a day in 21-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-03084014
2009
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,650 Total Patients Enrolled
4 Trials studying Desmoid Tumors
221 Patients Enrolled for Desmoid Tumors
Geraldine H O'Sullivan Coyne, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with certain medications called Gamma-secretase inhibitors or anti-notch antibody therapy in the past.
Research Study Groups:
This trial has the following groups:- Group 1: PF-03084014 in Desmoid Tumors/Aggressive Fibromatosis
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.
Are researchers currently looking for more participants for this clinical trial?
"The most recent update on clinicaltrials.gov shows that this study is not currently looking for patients, as of 9/14/2022. However, there are 95 other trials with open recruitment at this time."
Answered by AI
Which patients would be a good match for this research project?
"Eligibility for this study requires a diagnosis of fibromatosis, an aggressive subtype, and being between 18-120 years old. A total of 17 individuals are needed for the clinical trial."
Answered by AI
Is this the first time PF-03084014 has been investigated?
"Currently, there are 8 active studies related to PF-03084014. 1 of those is a Phase 3 clinical trial. Most of the studies for PF-03084014 are based in San Juan, Louisiana; however, there are 259 locations running these types of trials globally."
Answered by AI
Are people of all ages being accepted for this study, or are there age restrictions?
"The enrolment requirements for this trial stipulate that patients must be over 18 and not older than 120 years old."
Answered by AI
Are there long-term repercussions to taking PF-03084014?
"PF-03084014 is still in Phase 2 testing, so while there is some evidence that it is safe, there is no data yet to support its efficacy."
Answered by AI
How many people are enrolled in the trial currently?
"Unfortunately, this clinical trial is not currently looking for new patients. The study was first posted on October 31st, 2013 and was edited September 14th, 2020. There are other active studies though: 87 enrolling fibromatosis patients and 8 for PF-03084014 specifically."
Answered by AI
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