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AMXT1501 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Aminex Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable, locally advanced, or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will help establish how safe and effective AMXT 1501 dicaprate is when used by itself and in combination with DFMO in cancer patients.

Eligible Conditions
  • Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer that cannot be removed by surgery, has spread to other parts of your body, and there are no approved treatments available. Or, if there are approved treatments available, they have not worked for you.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine DLTs and RP2Ds in AMXT 1501 in combination with DFMO
Determine safety and tolerability of AMXT1501 in combination with DFMO
Secondary outcome measures
Characterize AMXT1501 in combination with DFMO on the expression of immune related gene signatures
Characterize investigator defined Duration of Response (DOR)
Characterize investigator defined response Overall Response Rate (ORR) using RECIST v1.1
+2 more
Other outcome measures
Evaluate AMXT1501 in combination with DFMO on PD biomarker by evaluating the level/concentration of polyamine uptake in the blood.

Side effects data

From 2008 Phase 3 trial • 375 Patients • NCT00118365
17%
FATIGUE
16%
DIARRHEA
10%
HEADACHE
8%
NAUSEA
6%
COLD SYMPTOMS
6%
HEARING CHANGE
6%
TINNITUS
5%
SINUS CONGESTION
5%
UTI
5%
WEIGHT LOSS
5%
VOMITING
4%
WEIGHT LOSS INTENTIONAL
4%
FLU
4%
OTHER* HEARTBURN
4%
DIZZINESS
4%
ANOREXIA
4%
BLEEDING RECTAL
4%
EPIGASTRIC PAIN
3%
BLEEDING RECTAL HEMORRHOIDS
3%
HEARING
3%
HYPERTENSION
3%
VERTIGO
3%
PAIN* BACK
3%
RESPIRATORY BRONCHITIS
3%
URI
3%
CONSTIPATION
3%
COUGH*
2%
HEARING LOSS
2%
PAIN* LOW BACK
2%
INFECTION* SINUS
2%
ORAL* COLD SORES, LIPS
2%
RASH
2%
INDIGESTION
2%
LABS DECREASE IN HGB
2%
LABS DECREASED WBC
2%
LABS HEMATURIA
2%
LABS HYPERLIPIDEMIA
2%
PAIN* RIGHT HEEL
2%
BALANCE
2%
ABDOMINAL PAIN
2%
OTHER* INSOMNIA
2%
CORONARY ARTERY DISEASE
2%
BALANCE DISTURBANCE
2%
BLOOD IN STOOL
2%
HEARING HEARING CHANGE
2%
PAIN* BACK PAIN
1%
INCREASE FLATULENCE
1%
PAIN* UPPER RIGHT QUADRANT
1%
RASH ABDOMINAL
1%
SINUSITIS
1%
STOOL* LOOSE
1%
STOOL* LOOSE, 2-3 DAYS/WEEK
1%
SURGERY* PROSTATE RESTRUCTURING-ELECTIVE
1%
STOMACH FLU
1%
NECK PAIN, INJURY
1%
VISION CATARACT
1%
PAIN* RIGHT HIP AND KNEE
1%
OTHER* INCREASE IN DEPRESSION
1%
PARATHYROID DISORDER
1%
BACK STRAIN
1%
BROKEN TOE
1%
FEELING HEATED AFTER TAKING MEDICATION
1%
HEARING DIFFICULTY
1%
HEMATURIA-MICROSCOPIC
1%
HIP AREA
1%
HYPERGLYCEMIA
1%
FLU DIARRHEA N/V
1%
INFECTION* PNEUMONIA POSS "SCAR" ON CXR
1%
BROKEN TOOTH
1%
MUSCULOSKELETAL SPRAINED ANKLE
1%
OTHER* DEPRESSION
1%
OTHER* SOB CHEST TIGHTNESS, POSSIBLE GERD SX
1%
PAIN* LOWER BACK STIFFNESS
1%
PERIPHERAL NERVOUS SYSTEM* NEURO SCIATICA RIGHT LEG
1%
HEARING AUDIO CHANGE SUBCLINICAL
1%
PERIPHERAL NERVOUS SYSTEM* OLD INJURY
1%
HEARING AUDIOMETRIC CHANGE BILATERAL
1%
OTHER* BACK PAIN AND DIARRHEA
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA
1%
LABS LOW HGB = 10%
1%
HEARING AUDIOGRAM GRADE 1 HEARING CHANGE
1%
GI INFLAMMATION COLITIS
1%
HEARING CHANGE NOTED ON AUDIO
1%
OTHER* GENITOURINARY "TWINGE" RIGHT TESTICLE
1%
OTHER* DRY EYES
1%
WEIGHT LOSS DURING RUN-IN PERIOD
1%
OTHER* INCREASED DEPRESSION
1%
OTHER* IMPOTENCE
1%
OTHER* DEPRESSION - RECURRANCE
1%
OTHER* PRURITUS, INTERMITTENT, BELLY, HIPS, LEGS
1%
OTHER* SCRATCHY THROAT/SNIFFLES
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA BILAT TINGLING IN SHOULDERS
1%
STOOL* HIGHER FREQUENCY
1%
OTHER* SLEEP APNEA
1%
OTHER* SNIFFLES
1%
PERIPHERAL NERVOUS SYSTEM* NEURO SCIATIC RIGHT LEG
1%
INCREASE FREQ OF HEMORHOIDAL BLEEDING
1%
PAIN* KNEE
1%
SURGERY* HERNIA
1%
HYPERKALEMIA
1%
UTI WITH SEPSIS
1%
MYOCARDIAL INFARCTION/CHEST PAIN, ABNORMAL CARDIAC ENZYMES
1%
HEARING CHANGE AUDIOGRAM
1%
INFECTION* LEFT INDEX FINGER
1%
LUMBAR HERNIATED DISC AND LUMBAR RADICULOPATHY
1%
DECREASED PERIPHERAL REFLEXES
1%
HEARING /INNER EAR - "STATIC NOISE" LEFT
1%
MUSCULOSKELETAL TAILBONE INJURY
1%
OTHER* ENDOCRINE -- HOT FLASHES
1%
OTHER* PRURITIUS LEGS
1%
HEARING AUDITORY
1%
OTHER* BIOPSY OF SKIN NEOPLASM, ABD. CYST AND THIGH
1%
OTHER* DISCOMFORT POST PROSTATE BIOPSY
1%
OTHER* LACERATION, ER VISIT
1%
OTHER* PHLEBITIS SUPERFICIAL LEFT FOREARM
1%
SINUS CONGESTION SINUSITIS
1%
GI CECUM BIOPSY: EROSIM WITH CHRONIC INFLAMMATION, NON-SPECIFIC
1%
SINUS INFECTION
1%
VOMITING NAUSEA AND VOMITING
1%
GI INCREASE IN GERD SYMPTOMS
1%
HEARING INNER EAR
1%
INFECTION* MIDDLE EAR-BLOCKED EUSTACHIAN TUBE
1%
VISION CATARACTS, "FLASHING LIGHT"
1%
OTHER* ARTHRALGIA LEFT ELBOW
1%
INFECTION* INSECT BITE RIGHT ANKLE
1%
OTHER* PLANTAR FASCIITIS
1%
PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA BOTH HANDS
1%
HOSPITALIZATION; FRACTURE OF LEFT ANKLE REQUIRING SURGICAL INTERVENTION
1%
LEFT LEG CELLULITIS
1%
ANOREXIA DECREASED APPETITE
1%
KNEE PAIN
1%
PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA
1%
COLD SYMPTOMS COUGH AND COLD SYMPTOMS
1%
HEARING SELF PERCEPTION, DIFFICULTY WITH DISCRIMINATION
1%
OTHER* PROSTATIC ADENOCARCINOMA DX 7/01/03 BY BX
1%
OTHER* PRURITIUS, HIPS AND BELLY
1%
HYPERTENSION /DIABETES
1%
ARTHRITIS ARTHRITIS FLARE UP - HANDS
1%
COLD/SINUS/EAR CONGESTION
1%
HEARING AUDIOGRAM ONLY
1%
INFECTION* RIGHT MIDDLE FINGER NAIL
1%
CELLULITIS
1%
KIDNEY CALCULUS
1%
HOSPITALIZATION FOR PANCREATIC NEOPLASM
1%
CHEST PAIN AND PALPITATIONS
1%
ABDOMINAL PAIN MOST LIKELY SECONDARY TO ACUTE CHOLECYSTITIS
1%
HOSPITALIZATION - OVERNIGHT OBSERVATION; LEFT KIDNEY BIOPSY
1%
ARTHIALGIA SHOULDER
1%
RIGHT HIP PAIN
1%
INFARCT MYOCARDIAL
1%
STERNAL WOUND SURGICAL DEBRIDEMENT
1%
ABDOMINAL PAIN DIARRHEA X 3-4 DAILY, CRAMPING
1%
ABDOMINAL PAIN ABDOMINAL CRAMPING
1%
ANXIETY AND DEPRESSION
1%
ARTHRITIS OSTEO
1%
BLOOD IN STOOL /HEMORRHOID
1%
CARDIAC* TACHYCARDIA
1%
DERMATOLOGY* ACTINIC KERATOSES REMOVED X3
1%
BLEEDING* PROLONGED MENSTRUAL BLEEDING
1%
BLOOD IN STOOL OCCULT
1%
FINGER LACERATION RIGHT HAND
1%
GI BLOATING / GAS
1%
CENTRAL NERVOUS SYSTEM HEADACHE RELATED TO CHOCOLATE
1%
DERMATOLOGY* 2 SPOTS ON SCALP
1%
FATIGUE* WEAKNESS
1%
FLU ACHY, NAUSEA, HEADACHE, COUGH
1%
CARDIAC* DX -- POSSIBLE RETURN OF RENOVASCULAR HTN
1%
CARDIAC* TACHYCARDIA EPISODES - INCREASED FREQUENCY
1%
COLD SYMPTOMS WITH COUGH
1%
CARDIAC* UNSTABLE ANGINA, CHEST PAIN
1%
CHANGE IN SIGNIFICANT OTHER'S PERCEPTION OF HEARING
1%
HAND PAIN
1%
INFECTION* LEFT LOWER LEG AK SITE
1%
HEMORRHOIDS
1%
GI UPSET STOMACH X 2 EPISODES
1%
HEARING SELF PERCEPTION
1%
FLU FLU-LIKE SYMPTOMS
1%
HEMMORRHOID
1%
ERECTILE DYSFUNTION
1%
FATIGUE* SYNCOPE
1%
GI ABDOMINAL BLOATING
1%
GI UPSET STOMACH X3 EPISODES
1%
GENITOURINARY URINATING
1%
INFECTION* SINUS INFECTION
1%
GI BARRETT'S ESOPHAGUS
1%
ORAL* PRE-ABSCESS
1%
HEARING CHANGE PER AUDIOGRAM
1%
HEARING AUDIOMETRIC CHANGE RIGHT EAR/ OVERALL NO SIGNIFICANT CHANGE
1%
HEARING DECREASE IN HEARING ABILITY
1%
INFECTION* FUNGAL, LEFT MIDDLE FINGER
1%
INFECTION* TOOTH
1%
LABS DECREASED HBG OF 10% BASELINE
1%
LABS ELEVATED BILIRUBIN
1%
ORAL* CHAPPED LIPS
1%
LABS DECREASED HEMOGLOBIN, REDRAW 12/4/01
1%
MUSCULOSKELETAL SHOULDER PAIN
1%
ORAL* BLISTER ROOF OF MOUTH
1%
MUSCULOSKELETAL SHOULDER PAIN CONTINUES
1%
OTHER CONJUNCTIVITIS, WITH OP EYE SURGERY
1%
OTHER* ALLERGY SYMPTOMS
1%
OTHER* ARTHRALGIA NECK
1%
OTHER* ARTHRALGIA LOWER BACK
1%
OTHER* PHLEBITIS LEFT FOREARM
1%
OTHER* PERIANAL SWELLING
1%
OTHER* PERIANAL ABSCESS
1%
PAIN
1%
ROSACASE
1%
WEIGHT LOSS DIETING
1%
OTHER* + + PITTING BILATERAL ANKLE EDEMA
1%
OTHER* BLADDER POLYP
1%
ORAL* LESION
1%
PAIN* RIGHT SIDED PAIN AFTER EXERCISE
1%
ABNORMAL PSA
1%
BACK PAIN, ON MOTRIN
1%
BIL LE EDEMA
1%
FEVER INTERMITTENT
1%
MUSCULOSKELETAL ANKLE INJURY, LEFT, R/T MISSTEP
1%
ORAL* PAIN - SOFT PALATE POST SURGICAL
1%
ORAL* SORENESS
1%
ORAL* YEAST INFECTION
1%
OTHER* BACK STRAIN
1%
OTHER* BLOATING
1%
OTHER* BLOATING, HX IBS
1%
OTHER* DECREASED THYROID FUNCTION, THIN HAIR, DECREASED TEMP, DRY SKIN
1%
OTHER* DEGENERATIVE JOINT DISEASE-RIGHT GREAT TOE
1%
OTHER* HSV OUTBREAK
1%
OTHER* HT OF GASTRIC ULCERS
1%
OTHER* HTN
1%
PAIN* EAR PAIN
1%
PAIN* LEFT HIP
1%
PAIN* MILD BACK PAIN "BURNING"
1%
PAIN* RIGHT SHOULDER
1%
RESPIRATORY SOB WITH EXERTION
1%
RESPIRATORY UPPER, SINUS PROBLEM ALLERGY RELATED
1%
STOMACH UPSET AND HEARTBURN
1%
TINNITUS MAY HAVE INCREASED
1%
CARDIAC* HEART MURMUR
1%
GASTRITIS
1%
OTHER* GENERAL ACHES
1%
LABS HGB DROP 10%
1%
COLD SYMPTOMS SINUS DRAINAGE
1%
DYSPNEA
1%
DYSPNEA (SHORTNESS OF BREATH)
1%
GI UPPER GI PAIN/ACID REFLUX
1%
HEARING DECREASE IN HEARING
1%
HERPES
1%
HIGH BLOOD PRESSURE
1%
HIP BURSITIS
1%
HTN
1%
INCREASED FLATULENCE; ANAL INCONTINENCE
1%
INCREASED FREQUENCY OF DROPPING ITEMS
1%
INFECTION* BLADDER INFECTION
1%
INFECTION* ESOPHAGITIS
1%
LEFT FLANK PAIN
1%
INFECTION* VAGINAL YEAST
1%
MUSCULOSKELETAL BILATERAL THIGH CRAMPS
1%
MUSCULOSKELETAL BUMP INTERIOR TO LEFT ELBOW
1%
MUSCULOSKELETAL OLECRANON BURSITIS/CELLULITIS/ELBOW SWELLING
1%
OTHER* BURSITIS - SHOULDER
1%
OTHER* LOOSE STOOL
1%
OTHER* LOWER EXTREMITY EDEMA
1%
OTHER* MILD PARESTHESIA
1%
OTHER* NASAL DISCHARGE
1%
OTHER* MODERATE PARESTHESIA
1%
OTHER* MODERATE PARESTHESIA IN RIGHT HAND
1%
OTHER* NAIL AVULSION, LEFT HALLUX NAIL
1%
OTHER* ULCERATION, RT LOWER EXTREMITY
1%
PAIN* FINGER PAIN
1%
PAIN* FROM SEED IMPLANT FOR PROSTATE CA
1%
PAIN* GAS
1%
PAIN* IN FRONT OF LEFT UPPER THIGH
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA L/HAND NUMBNESS
1%
RESPIRATORY ASTHMA FLARE-UP, WHEEZING, SOB
1%
RESPIRATORY BRONCHIAL ASTHMA
1%
RESPIRATORY PNEUMONIA
1%
RESPIRATORY SINUSITIS
1%
RESPIRATORY SOB 6 EPISODES
1%
RESPIRATORY UPPER, INFLUENZA
1%
RIGHT SIDE ABOVE EAR
1%
SERUM GLUCOSE
1%
STOOL* SOFT WITH ABDOMINAL CRAMPS
1%
SWELLING PERIPHERAL EDEMA
1%
SWOLLEN ANKLES (PERIPHERAL EDEMA)
1%
TOOTH ABCESS
1%
VISION BLURRED
1%
VISION FLOATERS, RIGHT EYE
1%
WEIGHT LOSS >5%
1%
CENTRAL NERVOUS SYSTEM MEMORY LOSS INCREASED
1%
HIP PAIN
1%
REMOVAL PRE-CAN SK.
1%
ANXIETY DEPRESSION
1%
HEART DISEASE: A. CORONARY, B. NON-Q-WAVE INFARCTION, C. UNSTABLE ANGINA; CORONARY STENTING
1%
PROBABLE RIGHT SUBCORTICAL INFARCT
1%
CENTRAL NERVOUS SYSTEM
1%
CHEST PAIN RELATED TO 4/18 REPORT FOR HEART BURN
1%
DERMATOLOGY* BCC
1%
DERMATOLOGY* FACIAL EDEMA
1%
DERMATOLOGY* ROSACEA
1%
DIZZINESS/VERTIGO EPISODE LASTING LESS THAN 10 SEC
1%
GI HEARTBURN X9 EPISODES
1%
HEADACHE WITH VISION INVOLVEMENT
1%
HEARING SLIGHT LOSS
1%
HYPERGLICEMIA
1%
HYPERTENSION RETURNED
1%
HYPERTENSION SUSPECT OCULAR HYPERTENSION
1%
INCREASE "BURPING"
1%
INCREASED ALT
1%
INCREASED AST
1%
INCREASED BILIRUBIN
1%
INCREASED CREATININE
1%
INDIGESTION HEART BURN
1%
INFECTION* EUSTACHIAN TUBES
1%
INFECTION* FUNGAL FINGERNAIL
1%
INFECTION* FUNGAL INFECTION FINGERNAILS
1%
INFECTION* INFECTED SCROTAL CYST
1%
INFECTION* YEAST
1%
PAIN* LEFT ANKLE
1%
PAIN* LEFT FOOT
1%
KIDNEY PROBLEMS
1%
KIDNEY PROBLEMS/RENAL-OTHER
1%
KIDNEY STONES
1%
LABS ANEMIA
1%
LABS ANEMIA: IRON DEFICIENCY
1%
LABS DECREASED HBG 10% FROM BASELINE
1%
LABS DECREASED HEMOGLOBIN NOT GREATER THAN 10% BASELINE
1%
LABS DECREASED HGB
1%
LABS DECREASED HGB GREATER THAN 10% BASELINE
1%
LABS DECREASED HGB, 10% FROM BASELINE
1%
LABS DECREASED HGB: CHRONIC
1%
LABS DROP IN HGB AND HEMATOCRIT
1%
LABS ELEVATED PSA
1%
LABS ENDOCRINE: ELEVATED BLOOD GLUCOSE
1%
LABS HGB DECREASE = 10%
1%
LABS HGB DECREASE GREATER THAN 10%
1%
LABS INCREASED CHOLESTEROL
1%
LABS PROTEINURIA
1%
LEG PAIN
1%
LOOSE STOOL
1%
LYMPHADENITIS RIGT NECK
1%
MUSCULOSKELETAL BACK PAIN
1%
MUSCULOSKELETAL BACK SPASM
1%
MUSCULOSKELETAL CRAMPS THIGH RIGHT
1%
MUSCULOSKELETAL CRAMPS THIGHS BILATERAL
1%
MUSCULOSKELETAL FOOT PAIN
1%
MUSCULOSKELETAL GANGLION CYST
1%
MUSCULOSKELETAL L2, L3 DISKS
1%
MUSCULOSKELETAL MUSCLE SORENESS - R FOREMARM
1%
MUSCULOSKELETAL MUSCLE WEAKNESS/SORENESS
1%
MUSCULOSKELETAL RIGHT KNEE TORN MENISCUS
1%
PAIN* LEFT HEEL BONE SPUR
1%
MUSCULOSKELETAL TORN ROTATOR CUFF, LEFT
1%
NAUSEA 5 EPISODES
1%
NAUSEA NAUSEA/DIARRHEA/HEADACHE
1%
NAUSEA RELATED TO NEW MEDICINE GLUCOPHAGE
1%
NEUROLOGY - DIZZINESS
1%
NEUROPATHY/SENSORY; TINGLING IN FINGERS
1%
NOSEBLEED
1%
NUMBNESS/TINGLING OF RIGHT ARM
1%
ORAL* DRY MOUTH
1%
ORAL* EXACERBATION/ LICHEN PLANUS
1%
ORAL* MOUTH SORE
1%
ORAL* MOUTH SORES
1%
ORAL* PAIN IN MOUTH POST PERIODONTAL SURGERY
1%
ORAL* PAIN RIGHT UPPER MOLAR
1%
OTHER* 2 LUMPS IN GROIN AREA (SIZE 2 X 2 CM)
1%
OTHER* ALLERGIC RHINITIS
1%
OTHER* ANAL FISTULA
1%
OTHER* ANAL FISTULA, SURG REPAIR
1%
OTHER* ARTHRALGIA LEFT ANKLE
1%
OTHER* BAD COLD X 3 WKS
1%
OTHER* BASAL CELL CARCINOMA LEFT CLAVICLE
1%
OTHER* BASAL CELL CARCINOMA LEFT JAW
1%
OTHER* BODY ACHES
1%
PAIN* MUSCLE STRAIN/SPASM
1%
PAIN* NECK
1%
PAIN* NECK & BACK
1%
OTHER* BRACHY THERAPY FOR PROSTATE CA
1%
OTHER* CELLULITIS RIGHT KNEE
1%
OTHER* CHEST X-RAY ABNORMAL, RIGHT UPPER LOBE LESION
1%
OTHER* CLAUDICATION
1%
OTHER* COLD SORE (NOSE)
1%
OTHER* CRAMPING
1%
OTHER* CYST IN GROIN WITH INFECTION
1%
OTHER* CYST ON BACK, DRAINED 10/10/00
1%
OTHER* DECREASED LIBIDO
1%
OTHER* DIABETES
1%
OTHER* DIFFICULTY SWALLOWING(DYSPHAGIA)
1%
OTHER* DX OF DIABETES
1%
OTHER* DYSPHAGIA
1%
OTHER* DYSPLASIA PROSTATE
1%
OTHER* EAR PAIN AND PRESSURE
1%
OTHER* ENLARGED PROSTATE, PT PLACED ON PROZOSIN
1%
OTHER* ESOPHAGEAL SPASM
1%
OTHER* F/U 6MO CT
1%
OTHER* FEELS "FUZZY" IN HER HEAD
1%
OTHER* FOOD POISONING: DIARRHEA. VOMITTING
1%
OTHER* GENITOURINARY, LEFT TESTICLE TENDER/SWOLLEN
1%
OTHER* GENITOURINARY/ VAGINITIS
1%
OTHER* GERD
1%
OTHER* GLAUCOMA
1%
OTHER* GLAUCOMA INCREASED
1%
PAIN* LEFT KNEE
1%
OTHER* HEARTBURN X 3 EPISODES
1%
OTHER* HEARTBURN X5 EPISODES
1%
OTHER* HEMOPTISIS
1%
OTHER* HOT AND SWEATY
1%
OTHER* INFECTION SINUS
1%
OTHER* INSOMNIA INCREASE
1%
OTHER* LEFT BREAST NODULE
1%
OTHER* LESION ON RIGHT THIGH
1%
OTHER* LUMP IN RIGHT GROIN, LYMPHADENOPATHY
1%
OTHER* OCCASIONAL BRUISING
1%
OTHER* OCULAR - INCREASE INTRAOCULAR PRESSURE LEFT EYE
1%
OTHER* OCULAR/VISUAL MYOPIA
1%
OTHER* ORAL SORENESS; ABCESS LOWER GUM
1%
OTHER* PAIN-LEFT ANKLE
1%
OTHER* PARESTHESIA-LEFT ARM
1%
OTHER* PLANTAR FASCIITIS LEFT FOOT
1%
OTHER* PRURITUS, INTERMITTENT, HIPS
1%
OTHER* RECTAL MOISTNESS
1%
OTHER* REDDENED EYES
1%
OTHER* RETINA EDEMA, POST OP
1%
OTHER* RIGHT EAR PRESSURE
1%
PAIN* LEFT SHOULDER
1%
PAIN* MUSCLE STRAIN (PAIN) IN LOWER BACK (OCCASIONAL)
1%
OTHER* SHADOW IN LEFT LUNG, POSS. BENIGN TUMOR OR SCAR TISSUE. CT 3/10/04
1%
OTHER* SORE THROAT
1%
OTHER* SPIDER BITE (LEG) SWELLING
1%
OTHER* STIFF FINGERS RIGHT. GOLF?
1%
OTHER* TURP
1%
OTHER* VAGINAL ITCHING
1%
OTHER* WHITE BLOOD CELL COUNT INCREASE
1%
OTOTOXICITY* LEFT EAR
1%
OTOTOXICITY* R/EAR CLOGGED
1%
PAIN AND LOCAL SWELLING, UPPER LEFT MOLAR
1%
PAIN IN LOWER CALF
1%
PAIN* "VAGUE PAIN" WEAKNESS LEFT LEG
1%
PAIN* ALL OVER BODY
1%
PAIN* BACK INTERMITTENT
1%
PAIN* BACK PAIN WHILE EXERCISING
1%
PAIN* BACK X2 EPISODES
1%
PAIN* BILATERAL KNEE SORENESS
1%
PAIN* BREAST TENDERNESS
1%
PAIN* CHEST
1%
PAIN* CHEST; EXACERBATION OF PREVIOUS CONDITION
1%
PAIN* EAR ACHE
1%
PAIN* FLANK PAIN, KIDNEY STONES
1%
PAIN* FOOT PAIN/SORE
1%
PAIN* HIPS/BACK
1%
PAIN* PAIN IN LEFT LEG AND KNEE
1%
PAIN* POST - SURGICAL
1%
PAIN* POST TOOTH EXTRACTION
1%
PAIN* PULLED MUSCLE
1%
PAIN* RIGHT BUTTOCKS
1%
PAIN* RIGHT FLANK
1%
PAIN* RIGHT HEEL - PLANTAR FASCIITIS
1%
PAIN* RIGHT KNEE
1%
PAIN* RIGHT KNEE - INCREASE
1%
PAIN* RIGHT LEG PAIN
1%
PAIN* RIGHT SHOULDER BLADE
1%
PAIN* RIGHT SHOULDER PAIN
1%
PAIN* SCORPION BITE RIGHT FOREARM
1%
PAIN* SHIN LACERATION
1%
PAIN* SHOULDERS
1%
PAIN* SORE KNEE
1%
PAIN* SORE ON THUMB
1%
PAIN* SORE THROAT
1%
PAIN* STIFF NECK R/T HEAD BUMP IN BATH
1%
PAIN* TAILBONE
1%
PERIPHERAL NERVOUS SYSTEM*
1%
PERIPHERAL NERVOUS SYSTEM* ARMS TINGLE/GO NUMB
1%
PERIPHERAL NERVOUS SYSTEM* RIGHT FOOT TOE NUMBNESS
1%
PERIPHERAL NERVOUS SYSTEM* SPINAL STENOSIS
1%
POSSIBLE RENAL CALCULUS (TOOK 1 VICODINE)
1%
PROTRUDING AND TENDER HEMORRHOIDS
1%
RASH BODY AND EXTREMITIES
1%
RASH RIGHT CHEEK
1%
RASH RIGHT FOOTECZEMA
1%
RASH RIGHT FOREARM
1%
RASH RIGHT LEG
1%
REFLUX GERD
1%
REFLUX GERD EPISODE
1%
REFLUX GERD EPISODIC
1%
REFLUX INCREASED GERD, NUMBER OF EPISODES
1%
RELEASE OF CARPAL TUNNEL IN RIGHT HAND
1%
RESPIRATORY ALLERGIES/ASTHMA
1%
RESPIRATORY ASTHMA FLARE UP
1%
RESPIRATORY CHEST COLD SX, DX WITH PNEUMONIA RIGHT LUNG
1%
RESPIRATORY CHEST CRX, PNEUMONIA RIGHT LUNG
1%
RESPIRATORY CHRONIC RHINITIS CONTINUES
1%
RESPIRATORY COLD
1%
RESPIRATORY COUGH
1%
RESPIRATORY DX WITH BRONCHIAL PNEUMONIA
1%
RESPIRATORY DYSPNEA ON EXERTION
1%
RESPIRATORY INFECTION, BRONCHITIS
1%
RT ELBOW FX
1%
SEASONAL ALLERGIES
1%
SINUS CONGESTION ALLERGIES
1%
SLEEP APNEA
1%
SLIGHT QUEEZY STOMACH
1%
SORE THROAT, MUCUS/COUGH
1%
SPINNING
1%
SPRAINED ANKLE
1%
SQUAMOUS CELL REMOVAL
1%
STOMACH PAIN
1%
STOMACH VIRUS (VIRAL GASTROECTERITIS)
1%
STOOL* LOOSER
1%
STOOL* TARRY
1%
SUBCONJUNCTIVAL HEMORRHAGE
1%
SURGERY* CABG WOUNDS (CORONARY ARTERY BYPASS GRAFT)
1%
SURGERY* TURP/HOSPITAL
1%
TINNITUS X1 EPISODE
1%
TOOTH INFECTION -> ROOT CANAL
1%
UPPER HARD PALATE 1 CM ERYTHEMA W/ ULCER
1%
UPPER RESPIRATORY INFECTION
1%
VISION DISTURBANCE
1%
VISION GLAUCOMA
1%
WEAKNESS
1%
WOUND INFECT
1%
ABDOMINAL PAIN CRAMPING
1%
HOSPITALIZATION VAGINAL BLEEDING TOTAL HYSTERECTOMY
1%
GASTRIC REFLUX
1%
HEARING OTOTOXICITY - AUDIOGRAM ONLY
1%
LOWBACK PAIN
1%
MUSCULOSKELETAL INCREASED BACK PAIN
1%
MUSCULOSKELETAL THIGH CRAMPS BILATERAL
1%
NAUSEA AND BELCHING
1%
NAUSEA POST SURGICAL
1%
ORAL* ULCERS
1%
FX (L) ELBOW
1%
GASTROINTESTINAL BLEEDING
1%
FORHEAD LESION REMOVAL
1%
LABS B-12 DEFICIENCY
1%
ORAL* GUM PAIN
1%
ORAL* INCREASED SALIVA
1%
SHINGLES
1%
CARDIAC* CONGESTIVE HEART FAILURE
1%
CARDIAC* FLUID IN LUNGS
1%
CHOLECYSTITIS
1%
ACUTE SHORTNESS OF BREATH R/T CHF, IMPROVED
1%
ACUTE MYOCARDIAL INFARCTION
1%
ACUTE SHORTNESS OF BREATH; CAD; UNSTABLE ANGINA
1%
ANEURYSM
1%
AORTIC STENOSIS
1%
ARRYTHMIA SINUS
1%
BROKEN RIGHT TIBIA UNDER KNEE D/T MVA
1%
CARCINOMA PROSTATIC
1%
BIPOLAR, EXACERBATED
1%
BASAL CELL CARCINOMA
1%
CHEST PAIN
1%
CELLULITIS OF RIGHT LEG
1%
CEREBRAL INFARCTION
1%
CENTRAL NERVOUS SYSTEM MEMORY PROBLEMS
1%
CHEST PAIN X 3 WKS, R/O CORONARY ARTERY DISEASE
1%
CONGESTIVE HEART FAILURE
1%
CHANGE
1%
GI BLEED R/T DIVERTICULA
1%
HOSPITALIZATION UTI
1%
HOSPITALIZATION; APPENDICITIS
1%
LEFT URETERAL STONES, OBSTRUCTING
1%
MVA
1%
CHANGE IN HEARING PER AUDIOGRAM
1%
MENTAL AND PHYSICAL BREAKDOWN
1%
CHEST PAIN WITH EXERTION
1%
OBSTRUCCTIVE JAUNDICE
1%
PANCREATITIS
1%
COLD
1%
COLD SYMPTOMS NASAL CONGESTION
1%
PNEUMONIA
1%
COLD SYMPTOMS COLD X3-4
1%
COLD SYMPTOMS HEAD
1%
PNEUMONIA; POSSIBLE COPD EXACERBATION
1%
PROLAPSED CYSTOCELE; TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY
1%
QUADRUPLE BYPASS SURGERY FOR CAD, UNSTABLE ANGINA
1%
COLD SYMPTOMS DX SINUS INFECTION
1%
ABDOMINAL PAIN ABD CRAMPING AND BLOAT
1%
RIGHT KNEE PAIN
1%
ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION
1%
ABDOMINAL PAIN DIARRHEA X 1-2 DAILY, CRAMPING
1%
ABDOMINAL PAIN CRAMPS/ CONSTIPATION
1%
COLD SYMPTOMS SNIFFLES
1%
ABDOMINAL PAIN EPIGASTRIC PAIN
1%
ABDOMINAL PAIN LEFT SIDE
1%
ABDOMINAL PAIN OCCASIONAL ABD CRAMP WITH LOOSE STOOL WHEN NERVIOUS
1%
ARTHRITIS
1%
ABDOMINAL PAIN STOMACH CRAMPS
1%
ABNORMAL X-RAY
1%
ANOREXIA LOSS OF APPETITE
1%
ANXIETY
1%
ARTHRITIS BACK PAIN WORSENING
1%
ANXIETY MOOD SWINGS, HOT FLASHES, ANXIETY
1%
ARTHRITIS BILATERAL KNEE PAIN R/T
1%
ASTHMA FLARE-UP
1%
GLUCOSURIA
1%
ASTHMA
1%
ARTHRITIS IN RIGHT KNEE
1%
ARTHRITIS LEFT HAND JOINT PAIN R/T ARTHRITIS
1%
ARTHRITIS LEFT WRIST
1%
ARTHRITIS TOE PAIN
1%
BELLS PALSY SIDE WEAKNESS
1%
ARTHRITIS R THUMB JOINT PAIN R/T
1%
COLD WITH URI SX
1%
BLEEDING IN EYE FROM THORN
1%
CONSTIPATION GETTING WORSE
1%
ARTHRITIS THUMB PAIN - ARTHRITIS BOTH HANDS
1%
BASAL CELL SKIN LESION REMOVAL
1%
CRAMPING
1%
DERMATOLOGY* BASAL CELL CARCINOMA
1%
BIL SWOLLEN FEET AND ANKLES
1%
GI STOMACH CRAMPS
1%
BLACK STOOLS (THINKS FROM MAALOX)
1%
BLEEDING RECTAL 4 EPISODES BRBPR
1%
BALANCE DISTANCE DISTURBANCE
1%
BALANCE BALANCE DISTURBANCE
1%
BLEEDING* VAGINAL BLEED
1%
BLEEDING, RECTAL
1%
BLEEDING* HEMATURIA
1%
BLOOD IN STOOL SMALL DOT
1%
BLEEDING* HEMORRHAGE HEMATURIA
1%
DEPRESSION, MOM'S DEATH
1%
DERMATOLOGY* ACTINIC KERATOSIS
1%
DERMATOLOGY* ANAL SKIN TAG REMOVED
1%
COUGH* DRY
1%
BPH
1%
BLOOD IN STOOL BURGUNDY
1%
CARDIAC* HEART ATTACK
1%
CAD
1%
CARDIAC* MYOCARDIAL INFARCTION BY EKG
1%
BRUISING LEFT HIP AREA
1%
CARDIAC* HEART PALPITATIONS AND HYPERTENSION
1%
CARDIAC* MILD AORTIC SCLEROSIS
1%
DERMATOLOGY* DRY SKIN, FEET
1%
CARDIAC* VASOVAGAL EPISODE
1%
CENTRAL NERVOUS SYSTEM INCREASE IN SEIZURES
1%
DERMATOLOGY* DERMATITIS/ EXACERBATION THUMBS
1%
DERMATOLOGY* MELANOMA UPPER ARM MOLE SKIN EXCISION
1%
DERMATOLOGY* IMPETIGO (NOSE)
1%
DERMATOLOGY* FUNGAL INF.
1%
DIAPHORESIS ABDOMINAL DISCOMFORT
1%
DERMATOLOGY* SKIN - BUMP, RED LEFT UPPER MOUTH
1%
DIARRHEA MILD
1%
DIARRHEA 3 EPISODES
1%
DIVERTICULITIS
1%
DIARRHEA LOOSER STOOL
1%
DIZZINESS FELL R/T LIGHT HEADED
1%
ELEVATED CREATININE BUN
1%
DIARRHEA + ABDOMINAL CRAMPS
1%
DIARRHEA OCCASIONAL
1%
DIARRHEA X 1 RELATED TO FOOD
1%
DYSPNEA ON EXERTION
1%
GOUT
1%
HEAD CONGESTION
1%
DIZZINESS/VERTIGO
1%
H. PYLORI +, STOMACH UPSET
1%
HAND SURGERY - TRIGGER FINGER
1%
HEARING DECREASED
1%
HEARING HEARING LOSS AUDIOMETRY ONLY
1%
EAR INFECTION
1%
ERYTHORMATOUS PLAQUES
1%
ELECT. BALANCE
1%
ELEVATED BLOOD PRESSURE
1%
ENLARGED THYROID
1%
HEARING HEARING LOSS - SIGNIFICANT OTHER PERCEPTION
1%
EPIGASTRIC PAIN GERD
1%
EXCISED MASS
1%
HYPERTENSION MILD/MOD
1%
FLU X5 DAYS
1%
FOOT CONTUSION
1%
FEVER
1%
FEVER X1
1%
FEVER X 2DAYS
1%
HEARING OTOTOXICITY
1%
HEARING RIGHT EAR "PLUGGED" X2 EPISODES
1%
H.PYLORI +, DX IBS - CONSTIPATION
1%
FLU INFECTION
1%
FLU SYMPTOMS
1%
GI HEARTBURN
1%
FX RT GREAT TOE
1%
GENITOURINARY - URINATING
1%
GI BLOATING
1%
GI HEARTBURN 1 - 2 EPISODES/WEEK
1%
GI ESOPHAGEAL FULLNESS RELATED TO GASTRO CIRCLAGE
1%
GI HEARTBURN 4 EPISODES WEEKLY
1%
GI HEARTBURN, 1 EPISODE PER WEEK
1%
HEARING LOSS - SIGNIFICANT OTHER PERCEPTION
1%
HEARING LOSS IN LEFT EAR
1%
HEADACHE PRESSURE
1%
HEADACHE SINUS PAIN
1%
HOT FLASHES
1%
HEARING AUDIOGRAM
1%
HEARING HEARING LOSS
1%
HEARING HEARNING LOSS/ SUBCLINICAL
1%
HEARTBURN
1%
HEMATARIA
1%
HEARING AUDIOMETRIC CHANGE RIGHT EAR
1%
SURGERY* RIGHT INGUINAL HERNIA REPAIR
1%
INCREASE STOOLING
1%
INCREASE STOOL FREQUENCY
1%
INCREASED ALKPHOSPHATASE
1%
TINGLING IN FINGER TIPS (NEUROPATHYSENSORY)
1%
TINNITUS INCREASED, LEFT EAR
1%
LABS 10% DROP HGB
1%
LABS DECREASE HGB GREATER THAN 10%
1%
LABS DECREASED HGB GREATER THAN 10% FROM BASELINE
1%
LABS LOW HGB
1%
LABS PSA ELEVATION
1%
LABS PSA LEVELS INCREASED (5 TO 8 TO 11)
1%
LABS WHITE BLOOD CELLS COUNT DOWN
1%
LABS LOW HEMOGLOBIN AFTER SURGERY
1%
TINNITUS PRE-EXISTING - INCREASED
1%
TINNITUS VERY SLIGHT
1%
LOW BLOOD COUNT
1%
LOW BONE DENSITY
1%
MASS FOUND ON CRX
1%
MUCUS/COUGHING
1%
MUSCULOSKELETAL ACHE ARM LEFT
1%
MUSCULOSKELETAL LEFT HIP PAIN
1%
MUSCULOSKELETAL MIDDLE FINGER CYST
1%
MUSCULOSKELETAL MINOR BACK PAIN
1%
MUSCULOSKELETAL MUSCLE PAIN, RIGHT LEG
1%
MUSCULOSKELETAL SCIATICA
1%
NECK AND SHOULDER PAIN
1%
NECK PAIN
1%
OCCULAR MIGRAIN
1%
OLECRANON BURSITIS
1%
ORAL HAD BUMP ON SURFACE OF TONGUE
1%
ORAL SORE NEAR RIGHT INCISOR
1%
ORAL* CANKER SORES
1%
ORAL* CANKER SORES ON TONGUE
1%
ORAL* DRY THROAT
1%
VERTIGO POSITIONAL
1%
OTHER* ALLERGIES
1%
OTHER* ARTHRALGIA LEFT SHOULDER
1%
OTHER* ARTHRALGIA LEFT WRIST
1%
VISION SUB-CONJUNCTIVAL HEMMORHAGE
1%
WEAKNESS NEW - LEFT ARM
1%
OTHER* BURSITIS IN RIGHT SHOULDER
1%
OTHER* BURSITIS RIGHT SHOULDER
1%
OTHER* BURSITIS-ELBOW
1%
OTHER* EDEMA
1%
OTHER* EDEMA LEFT EXTREMITY
1%
OTHER* GU - URINARY FREQUENCY
1%
OTHER* IGA GLOMERULONEPHRITIS
1%
OTHER* INCREASED STRESS
1%
OTHER* IRRITATED THROAT
1%
OTHER* KIDNEY STONES
1%
OTHER* MUCLE PULLED BACK
1%
OTHER* OSTEOPOROSIS
1%
OTHER* POST NASAL DRIP
1%
OTHER* PROSTATE CANCER
1%
OTHER* RIGHT GREAT TOE WITH REDDISH SPOT
1%
OTHER* RIGHT INGUINAL HERNIA
1%
OTHER* ROOT CANAL X3
1%
OTHER* RUNNY NOSE
1%
OTHER* SINUS PROBLEM
1%
OTHER* SKIN LESION LEFT FOREARM
1%
OTHER* TENDON, BRUISED RIGHT ELBOW
1%
OTHER* THROAT IRRITATION
1%
OTHER* TINGLING LEFT FOOT
1%
OTHER* URINARY URGENCY
1%
OTOTOXICITY* TINNITUS LEFT EAR
1%
PAIN* BACK LOWER LEFT
1%
PAIN* GREAT TOES PAINFUL
1%
PAIN* GROIN PAIN/ PUBIC BONE WITH LONG SITTING
1%
PAIN* JOINTS OF LEFT SIDE
1%
PAIN* LEFT THUMB
1%
PAIN* POST ORAL SURGERY
1%
PAIN* POST ROOT CANAL
1%
PAIN* POST SURGICAL
1%
PAIN* RIGHT GREAT TOE
1%
PAIN* RIGHT LOWER BACK AND LEFT KNEE PAIN
1%
PAIN* TESTICULAR SORENESS & SWELLING
1%
PAIN* TOOTH
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA LEFT SHOULDER PINCHED NERVE
1%
PERIPHERAL NERVOUS SYSTEM* PERESTHESIA, FEET, INCREASED FROM BASELINE
1%
POST NASAL DRIP
1%
RASH EXACERBATION OF SEASONAL ITCHY RASH
1%
RASH URTICARIA RIGHT BUTTOCK
1%
REFLUX
1%
REFLUX ACID
1%
RESPIRATORY RHINITIS
1%
RESPIRATORY SHORT OF BREATH
1%
RESPIRATORY SHORTNESS OF BREATH
1%
RESPIRATORY SHORTNESS OF BREATH 2X
1%
SKIN RASH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Eflornithine and Sulindac)
Arm II (Placebo)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Dose escalation of DFMO with the Part 1 AMXT1501 RP2D fixed dose will follow a 3 + 3 dose escalation design. The AMXT 1501 starting dose administered in the first cohort will be one level below the AMXT 1501 Part 1 RP2D with 500 mg DFMO BID. The morning dose will be given orally of both AMXT1501 and DFMO, in a fasted state. The evening dose of DFMO alone will be given prior to bed-time for 28 days per cycle. The patient can be treated for additional 28 day treatment cycles as deemed appropriate by their study investigator. Dose escalation of DFMO alone will increase per Part 2 cohort.
Group II: Part 1Experimental Treatment2 Interventions
Dose escalation of AMXT1501 with a fixed low dose of DFMO will follow a 3 + 3 dose escalation design. The AMXT 1501 starting dose administered in the first cohort will be 80 mg (2 capsules); each capsule contains 40 mg of active drug. The dose will be given orally, once daily, fasted state alone for 14 days, and starting on Day 15 AMXT 1501 80 mg given in combination with fixed low-dose oral DFMO at 250mg 2x per day (BID), for an additional 14 days; for a total 28 days of treatment per cycle. Cycle 2 includes AMXT1501 + DFMO that will be administered for 28 days. The patient can be treated for additional 28 day treatment cycles as deemed appropriate by their study investigator. Dose escalation of AMXT1501 alone will increase per Part 1 cohort.
Group III: ExpansionExperimental Treatment2 Interventions
The expansion cohort will include up to 14 evaluable patients at a proposed RP2D level of AMXT1501 and DFMO defined by Part 2 to further characterize safety at proposed RP2D dose level with repeat dosing, and characterize early anti-tumor activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMXT1501
2018
Completed Phase 1
~60
DFMO
2010
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Aminex Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
56 Total Patients Enrolled
Jackie Walling, MBChB PhDStudy ChairAminex
1 Previous Clinical Trials
56 Total Patients Enrolled
Paul Schechter, MD, PhDStudy DirectorAminex

Frequently Asked Questions

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

Are there any vacancies left to participate in this research program?

"As per the clinicaltrials.gov website, this trial is not presently enlisting participants -the study was initially posted on June 12th 2018 and last modified on August 12th 2022. However, there are a total of 1,034 other trials seeking enrolment at present."

Answered by AI

Is this trailblazing study the initial of its kind?

"The seminal trial for AMXT1501, sponsored by Aminex Therapeutics, Inc., occurred in 2018 and included 56 participants. Subsequently, the drug underwent a successful Phase 1 approval process. Currently, only one live investigation of this medication is being hosted by Aminex Therapeutics, Inc.."

Answered by AI

Could you provide an overview of the other experiments in which AMXT1501 has been utilized?

"At present, 1 trial is actively studying AMXT1501 with zero trials in the final Phase 3. Primarily conducted within San Antonio, Texas, 5 different medical sites are evaluating this medication."

Answered by AI

How many participants have signed up to be part of this clinical experiment?

"This medical trial is currently not enlisting patients. It was first published on June 12th 2018 and modified most recently on August 12th 2022. There are presently 1033 trials for malignancies admitting participants, as well as one study with AMXT1501 actively recruiting individuals."

Answered by AI

What are the primary aims of this research?

"This clinical trial will be conducted for a two year period to assess the Drug-Related Limiting Toxicities (DLTs) and Recommended Phase 2 Doses (RP2Ds) of AMXT 1501 in combination with DFMO. The primary outcome measure is Investigator-defined Overall Response Rate using RECIST v1.1 criteria, while secondary measures include pharmacokinetic analysis assessing AUC and Cmax parameters of both compounds alone or when administered together."

Answered by AI

What potential hazards do people face when utilizing AMXT1501?

"Due to the minimal clinical data available, AMXT1501 was assigned a score of 1 on our safety rating scale. This is because it's currently undergoing Phase 1 trials and requires more evidence before further efficacy and safety can be determined."

Answered by AI

How many venues are implementing this clinical experiment?

"This clinical trial is run in 5 different medical centres, the most prominent being Next Oncology - San Antonio in Houston, MD Anderson Cancer Center in Fairfax and Virginia Cancer Centre in Austin. Two additional locations are also included."

Answered by AI
~8 spots leftby Mar 2025