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AMXT 1501 + DFMO for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Aminex Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is able to take oral medications and willing to use an at-home infusion pump
Active secondary malignancies will not be allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study the safety and dosage of a new cancer treatment drug.
Who is the study for?
This trial is for patients aged 12 and older, weighing over 40 kg, with various advanced solid tumors where standard treatments have failed or are not available. Participants must be able to take oral medication, use an at-home infusion pump, provide a CSF sample and tumor tissue biopsy, and agree to contraception use. Exclusions include recent cancer treatment within the last 4-6 weeks, uncontrolled seizures in DIPG/DMG patients, significant cardiovascular disease within the past 6 months, active liver disease or infections like HIV.Check my eligibility
What is being tested?
The study tests AMXT 1501 dicaprate combined with IV DFMO on safety and optimal dosing levels in cancer patients. It's a Phase 1B/2A trial focusing on those with unresectable or metastatic solid tumors including ovarian cancer and gliomas among others.See study design
What are the potential side effects?
While specific side effects are not listed here for AMXT1501 + DFMO combination therapy; generally such treatments may cause fatigue, nausea, digestive issues potentially due to oral intake of drugs; skin reactions from infusions; as well as risks associated with compromised bone marrow function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills and am willing to use a pump for medicine at home.
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I do not have any other active cancers.
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I agree to use effective birth control during and for 3 months after the study.
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I have been diagnosed with DIPG or DMG and meet specific study requirements.
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I am 18 years old or older.
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My cancer cannot be surgically removed, has spread, and standard treatments have failed or are not available.
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I am 12 years or older and weigh more than 40 kg.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with DIPG or DMG.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 IV DFMO
Determine safety and tolerability of AMXT1501 in combination with IV DFMO
Secondary outcome measures
Characterize AMXT1501 and IV 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 moreOther outcome measures
Palladium
Side effects data
From 2008 Phase 3 trial • 375 Patients • NCT0011836517%
FATIGUE
16%
DIARRHEA
10%
HEADACHE
8%
NAUSEA
6%
TINNITUS
6%
COLD SYMPTOMS
6%
HEARING CHANGE
5%
SINUS CONGESTION
5%
UTI
5%
WEIGHT LOSS
5%
VOMITING
4%
EPIGASTRIC PAIN
4%
WEIGHT LOSS INTENTIONAL
4%
BLEEDING RECTAL
4%
FLU
4%
OTHER* HEARTBURN
4%
DIZZINESS
4%
ANOREXIA
3%
BLEEDING RECTAL HEMORRHOIDS
3%
HEARING
3%
RESPIRATORY BRONCHITIS
3%
VERTIGO
3%
HYPERTENSION
3%
PAIN* BACK
3%
URI
3%
CONSTIPATION
3%
COUGH*
2%
LABS HEMATURIA
2%
LABS HYPERLIPIDEMIA
2%
PAIN* LOW BACK
2%
BALANCE DISTURBANCE
2%
LABS DECREASED WBC
2%
HEARING LOSS
2%
INFECTION* SINUS
2%
ORAL* COLD SORES, LIPS
2%
PAIN* BACK PAIN
2%
PAIN* RIGHT HEEL
2%
RASH
2%
INDIGESTION
2%
LABS DECREASE IN HGB
2%
BALANCE
2%
ABDOMINAL PAIN
2%
OTHER* INSOMNIA
2%
CORONARY ARTERY DISEASE
2%
BLOOD IN STOOL
2%
HEARING HEARING CHANGE
1%
VISION CATARACT
1%
CENTRAL NERVOUS SYSTEM HEADACHE RELATED TO CHOCOLATE
1%
COLD WITH URI SX
1%
DERMATOLOGY* 2 SPOTS ON SCALP
1%
DERMATOLOGY* ACTINIC KERATOSES REMOVED X3
1%
HEARING DECREASE IN HEARING ABILITY
1%
OTHER* ALLERGIC RHINITIS
1%
OTHER* INFECTION SINUS
1%
FX (L) ELBOW
1%
RIGHT HIP PAIN
1%
BLOOD IN STOOL /HEMORRHOID
1%
CARDIAC* HEART ATTACK
1%
LABS HGB DECREASE GREATER THAN 10%
1%
OTHER* SCRATCHY THROAT/SNIFFLES
1%
GASTROINTESTINAL BLEEDING
1%
HEARING AUDIOGRAM GRADE 1 HEARING CHANGE
1%
ENLARGED THYROID
1%
ERECTILE DYSFUNTION
1%
ARTHIALGIA SHOULDER
1%
STERNAL WOUND SURGICAL DEBRIDEMENT
1%
BALANCE BALANCE DISTURBANCE
1%
CARDIAC* TACHYCARDIA
1%
BIPOLAR, EXACERBATED
1%
GI ABDOMINAL BLOATING
1%
ARTHRITIS TOE PAIN
1%
BROKEN TOE
1%
CHEST PAIN AND PALPITATIONS
1%
GI INCREASE IN GERD SYMPTOMS
1%
KIDNEY CALCULUS
1%
HEARING INNER EAR
1%
H. PYLORI +, STOMACH UPSET
1%
CARDIAC* DX -- POSSIBLE RETURN OF RENOVASCULAR HTN
1%
CARDIAC* TACHYCARDIA EPISODES - INCREASED FREQUENCY
1%
GI UPSET STOMACH X3 EPISODES
1%
HAND SURGERY - TRIGGER FINGER
1%
HEAD CONGESTION
1%
ABDOMINAL PAIN MOST LIKELY SECONDARY TO ACUTE CHOLECYSTITIS
1%
HEARING CHANGE NOTED ON AUDIO
1%
HEARING DECREASED
1%
HEARING DIFFICULTY
1%
OTHER* DX OF DIABETES
1%
HEARING OTOTOXICITY - AUDIOGRAM ONLY
1%
MUSCULOSKELETAL BILATERAL THIGH CRAMPS
1%
OTHER* SLEEP APNEA
1%
RESPIRATORY PNEUMONIA
1%
RIGHT SIDE ABOVE EAR
1%
TINGLING IN FINGER TIPS (NEUROPATHYSENSORY)
1%
MENTAL AND PHYSICAL BREAKDOWN
1%
DIARRHEA OCCASIONAL
1%
HEARING /INNER EAR - "STATIC NOISE" LEFT
1%
HEARING AUDIOMETRIC CHANGE BILATERAL
1%
HEMATARIA
1%
HEMORRHOIDS
1%
NEUROLOGY - DIZZINESS
1%
OTHER* ALLERGIES
1%
OTHER* ALLERGY SYMPTOMS
1%
OTHER* BAD COLD X 3 WKS
1%
RESPIRATORY SHORTNESS OF BREATH
1%
TINNITUS X1 EPISODE
1%
BACK STRAIN
1%
GENITOURINARY - URINATING
1%
HEARING AUDIOGRAM
1%
DYSPNEA ON EXERTION
1%
FLU SYMPTOMS
1%
HEARING HEARNING LOSS/ SUBCLINICAL
1%
HEARING SELF PERCEPTION, DIFFICULTY WITH DISCRIMINATION
1%
OTHER* ENDOCRINE -- HOT FLASHES
1%
HEMATURIA-MICROSCOPIC
1%
OTHER* ARTHRALGIA LOWER BACK
1%
PAIN
1%
MUSCULOSKELETAL CRAMPS THIGHS BILATERAL
1%
NOSEBLEED
1%
NUMBNESS/TINGLING OF RIGHT ARM
1%
OTHER* LACERATION, ER VISIT
1%
OTHER* SOB CHEST TIGHTNESS, POSSIBLE GERD SX
1%
OTOTOXICITY* LEFT EAR
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA BILAT TINGLING IN SHOULDERS
1%
TINNITUS PRE-EXISTING - INCREASED
1%
ANXIETY MOOD SWINGS, HOT FLASHES, ANXIETY
1%
UTI WITH SEPSIS
1%
ABNORMAL PSA
1%
FATIGUE* WEAKNESS
1%
FEVER
1%
FLU DIARRHEA N/V
1%
FLU FLU-LIKE SYMPTOMS
1%
ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION
1%
ABDOMINAL PAIN DIARRHEA X 3-4 DAILY, CRAMPING
1%
ARTHRITIS BILATERAL KNEE PAIN R/T
1%
ABDOMINAL PAIN ABDOMINAL CRAMPING
1%
BASAL CELL CARCINOMA
1%
HOSPITALIZATION; APPENDICITIS
1%
HOSPITALIZATION; FRACTURE OF LEFT ANKLE REQUIRING SURGICAL INTERVENTION
1%
ANXIETY AND DEPRESSION
1%
LEFT URETERAL STONES, OBSTRUCTING
1%
FINGER LACERATION RIGHT HAND
1%
FORHEAD LESION REMOVAL
1%
ARTHRITIS IN RIGHT KNEE
1%
HYPERGLYCEMIA
1%
ACUTE MYOCARDIAL INFARCTION
1%
ANEURYSM
1%
CELLULITIS
1%
ANOREXIA DECREASED APPETITE
1%
OBSTRUCCTIVE JAUNDICE
1%
FEELING HEATED AFTER TAKING MEDICATION
1%
AORTIC STENOSIS
1%
CONGESTIVE HEART FAILURE
1%
INFARCT MYOCARDIAL
1%
ACUTE SHORTNESS OF BREATH; CAD; UNSTABLE ANGINA
1%
CHEST PAIN X 3 WKS, R/O CORONARY ARTERY DISEASE
1%
ARRYTHMIA SINUS
1%
ARTHRITIS ARTHRITIS FLARE UP - HANDS
1%
ASTHMA FLARE-UP
1%
CELLULITIS OF RIGHT LEG
1%
LEFT LEG CELLULITIS
1%
PROLAPSED CYSTOCELE; TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY
1%
ARTHRITIS LEFT WRIST
1%
ARTHRITIS THUMB PAIN - ARTHRITIS BOTH HANDS
1%
BASAL CELL SKIN LESION REMOVAL
1%
BROKEN TOOTH
1%
HEARING SELF PERCEPTION
1%
HOSPITALIZATION - OVERNIGHT OBSERVATION; LEFT KIDNEY BIOPSY
1%
HOSPITALIZATION FOR PANCREATIC NEOPLASM
1%
HOSPITALIZATION UTI
1%
MYOCARDIAL INFARCTION/CHEST PAIN, ABNORMAL CARDIAC ENZYMES
1%
FLU X5 DAYS
1%
GI BARRETT'S ESOPHAGUS
1%
ARTHRITIS BACK PAIN WORSENING
1%
ARTHRITIS R THUMB JOINT PAIN R/T
1%
LUMBAR HERNIATED DISC AND LUMBAR RADICULOPATHY
1%
RIGHT KNEE PAIN
1%
PARATHYROID DISORDER
1%
ARTHRITIS LEFT HAND JOINT PAIN R/T ARTHRITIS
1%
QUADRUPLE BYPASS SURGERY FOR CAD, UNSTABLE ANGINA
1%
BLEEDING* PROLONGED MENSTRUAL BLEEDING
1%
HIGH BLOOD PRESSURE
1%
ARTHRITIS OSTEO
1%
BIL SWOLLEN FEET AND ANKLES
1%
BELLS PALSY SIDE WEAKNESS
1%
BLEEDING* HEMORRHAGE HEMATURIA
1%
FEVER X 2DAYS
1%
FOOT CONTUSION
1%
GI BLOATING / GAS
1%
BACK PAIN, ON MOTRIN
1%
FEVER X1
1%
COLD SYMPTOMS COUGH AND COLD SYMPTOMS
1%
HYPERKALEMIA
1%
INFECTION* PNEUMONIA POSS "SCAR" ON CXR
1%
INDIGESTION HEART BURN
1%
COLD/SINUS/EAR CONGESTION
1%
CONSTIPATION GETTING WORSE
1%
INCREASED CREATININE
1%
BLEEDING* VAGINAL BLEED
1%
BLEEDING, RECTAL
1%
CHANGE IN SIGNIFICANT OTHER'S PERCEPTION OF HEARING
1%
FLU ACHY, NAUSEA, HEADACHE, COUGH
1%
BLOOD IN STOOL OCCULT
1%
BRUISING LEFT HIP AREA
1%
HYPERTENSION /DIABETES
1%
CARDIAC* UNSTABLE ANGINA, CHEST PAIN
1%
CHANGE
1%
GENITOURINARY URINATING
1%
DERMATOLOGY* BASAL CELL CARCINOMA
1%
GI CECUM BIOPSY: EROSIM WITH CHRONIC INFLAMMATION, NON-SPECIFIC
1%
COLD SYMPTOMS WITH COUGH
1%
DECREASED PERIPHERAL REFLEXES
1%
CENTRAL NERVOUS SYSTEM MEMORY PROBLEMS
1%
COLD SYMPTOMS NASAL CONGESTION
1%
CRAMPING
1%
DIARRHEA X 1 RELATED TO FOOD
1%
DERMATOLOGY* DRY SKIN, FEET
1%
DERMATOLOGY* SKIN - BUMP, RED LEFT UPPER MOUTH
1%
GI INFLAMMATION COLITIS
1%
HAND PAIN
1%
INCREASE STOOL FREQUENCY
1%
INCREASED AST
1%
INCREASED ALKPHOSPHATASE
1%
INFECTION* FUNGAL INFECTION FINGERNAILS
1%
INFECTION* MIDDLE EAR-BLOCKED EUSTACHIAN TUBE
1%
LABS ELEVATED PSA
1%
DIARRHEA MILD
1%
GI HEARTBURN
1%
EPIGASTRIC PAIN GERD
1%
ERYTHORMATOUS PLAQUES
1%
HEARTBURN
1%
INCREASE FREQ OF HEMORHOIDAL BLEEDING
1%
INCREASE STOOLING
1%
FATIGUE* SYNCOPE
1%
HEADACHE WITH VISION INVOLVEMENT
1%
HEARING AUDITORY
1%
H.PYLORI +, DX IBS - CONSTIPATION
1%
GI UPSET STOMACH X 2 EPISODES
1%
HEARING AUDIO CHANGE SUBCLINICAL
1%
GOUT
1%
INFECTION* INSECT BITE RIGHT ANKLE
1%
INFECTION* RIGHT MIDDLE FINGER NAIL
1%
INFECTION* YEAST
1%
LABS HGB DECREASE = 10%
1%
LABS LOW HEMOGLOBIN AFTER SURGERY
1%
INCREASED BILIRUBIN
1%
MUSCULOSKELETAL MUSCLE PAIN, RIGHT LEG
1%
INFECTION* FUNGAL, LEFT MIDDLE FINGER
1%
HEARING AUDIOGRAM ONLY
1%
HEARING AUDIOMETRIC CHANGE RIGHT EAR/ OVERALL NO SIGNIFICANT CHANGE
1%
HEARING CHANGE AUDIOGRAM
1%
HEARING CHANGE PER AUDIOGRAM
1%
LABS 10% DROP HGB
1%
HEARING HEARING LOSS AUDIOMETRY ONLY
1%
INFECTION* LEFT INDEX FINGER
1%
INFECTION* LEFT LOWER LEG AK SITE
1%
INFECTION* SINUS INFECTION
1%
HEARING HEARING LOSS
1%
HTN
1%
HEMMORRHOID
1%
HEARING LOSS IN LEFT EAR
1%
HIP AREA
1%
INFECTION* EUSTACHIAN TUBES
1%
INFECTION* FUNGAL FINGERNAIL
1%
OTHER* OCULAR/VISUAL MYOPIA
1%
OTHER* PERIANAL SWELLING
1%
OTHER* PLANTAR FASCIITIS
1%
INFECTION* TOOTH
1%
KNEE PAIN
1%
LEFT FLANK PAIN
1%
NECK AND SHOULDER PAIN
1%
NECK PAIN
1%
LABS DECREASED HEMOGLOBIN, REDRAW 12/4/01
1%
LABS ANEMIA: IRON DEFICIENCY
1%
LABS ELEVATED BILIRUBIN
1%
MUSCULOSKELETAL SPRAINED ANKLE
1%
LABS LOW HGB = 10%
1%
LABS DECREASE HGB GREATER THAN 10%
1%
LABS DECREASED HBG OF 10% BASELINE
1%
LABS B-12 DEFICIENCY
1%
LABS ENDOCRINE: ELEVATED BLOOD GLUCOSE
1%
MUSCULOSKELETAL MINOR BACK PAIN
1%
LABS DROP IN HGB AND HEMATOCRIT
1%
OTHER* SNIFFLES
1%
MUSCULOSKELETAL MIDDLE FINGER CYST
1%
NAUSEA RELATED TO NEW MEDICINE GLUCOPHAGE
1%
ORAL* PRE-ABSCESS
1%
MUSCULOSKELETAL GANGLION CYST
1%
NECK PAIN, INJURY
1%
MUSCULOSKELETAL BACK PAIN
1%
MUSCULOSKELETAL INCREASED BACK PAIN
1%
MUSCULOSKELETAL SHOULDER PAIN CONTINUES
1%
MUSCULOSKELETAL TAILBONE INJURY
1%
ORAL* CHAPPED LIPS
1%
MUSCULOSKELETAL CRAMPS THIGH RIGHT
1%
OTHER* ARTHRALGIA LEFT ELBOW
1%
OTHER* BACK PAIN AND DIARRHEA
1%
OTHER* BLADDER POLYP
1%
MUSCULOSKELETAL SHOULDER PAIN
1%
ORAL* CANKER SORES ON TONGUE
1%
ORAL* ULCERS
1%
OTHER* 2 LUMPS IN GROIN AREA (SIZE 2 X 2 CM)
1%
ORAL* BLISTER ROOF OF MOUTH
1%
OTHER* DEPRESSION - RECURRANCE
1%
OTHER* HEARTBURN X 3 EPISODES
1%
OTHER* HEARTBURN X5 EPISODES
1%
OTHER* ARTHRALGIA NECK
1%
OTHER* IMPOTENCE
1%
OTHER CONJUNCTIVITIS, WITH OP EYE SURGERY
1%
OTHER* + + PITTING BILATERAL ANKLE EDEMA
1%
OTHER* BASAL CELL CARCINOMA LEFT CLAVICLE
1%
OTHER* ARTHRALGIA LEFT WRIST
1%
OTHER* PRURITIUS LEGS
1%
OTHER* BIOPSY OF SKIN NEOPLASM, ABD. CYST AND THIGH
1%
OTHER* GENITOURINARY, LEFT TESTICLE TENDER/SWOLLEN
1%
OTHER* DISCOMFORT POST PROSTATE BIOPSY
1%
OTHER* DEPRESSION
1%
OTHER* FOOD POISONING: DIARRHEA. VOMITTING
1%
OTHER* CYST IN GROIN WITH INFECTION
1%
OTHER* DRY EYES
1%
OTHER* INCREASED DEPRESSION
1%
OTHER* MILD PARESTHESIA
1%
OTHER* ORAL SORENESS; ABCESS LOWER GUM
1%
OTHER* GENITOURINARY "TWINGE" RIGHT TESTICLE
1%
OTHER* PHLEBITIS LEFT FOREARM
1%
OTHER* INCREASE IN DEPRESSION
1%
OTHER* NASAL DISCHARGE
1%
OTHER* PAIN-LEFT ANKLE
1%
OTHER* PARESTHESIA-LEFT ARM
1%
OTHER* PERIANAL ABSCESS
1%
OTHER* TENDON, BRUISED RIGHT ELBOW
1%
OTHER* RECTAL MOISTNESS
1%
OTHER* PROSTATE CANCER
1%
OTHER* PHLEBITIS SUPERFICIAL LEFT FOREARM
1%
OTHER* PRURITIUS, HIPS AND BELLY
1%
OTHER* TINGLING LEFT FOOT
1%
OTHER* PROSTATIC ADENOCARCINOMA DX 7/01/03 BY BX
1%
OTHER* PRURITUS, INTERMITTENT, BELLY, HIPS, LEGS
1%
OTHER* PRURITUS, INTERMITTENT, HIPS
1%
OTOTOXICITY* R/EAR CLOGGED
1%
PAIN* IN FRONT OF LEFT UPPER THIGH
1%
OTHER* STIFF FINGERS RIGHT. GOLF?
1%
OTHER* THROAT IRRITATION
1%
PAIN* RIGHT HEEL - PLANTAR FASCIITIS
1%
PAIN* KNEE
1%
PAIN* TESTICULAR SORENESS & SWELLING
1%
PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA BOTH HANDS
1%
PERIPHERAL NERVOUS SYSTEM* NEURO SCIATICA RIGHT LEG
1%
PAIN* LEFT FOOT
1%
PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA
1%
PAIN* TOOTH
1%
PERIPHERAL NERVOUS SYSTEM* NEURO SCIATIC RIGHT LEG
1%
PERIPHERAL NERVOUS SYSTEM* OLD INJURY
1%
PAIN* RIGHT HIP AND KNEE
1%
PAIN* LOWER BACK STIFFNESS
1%
PAIN* RIGHT SHOULDER PAIN
1%
PAIN* UPPER RIGHT QUADRANT
1%
PERIPHERAL NERVOUS SYSTEM* ARMS TINGLE/GO NUMB
1%
RASH ABDOMINAL
1%
PAIN* RIGHT KNEE - INCREASE
1%
PERIPHERAL NERVOUS SYSTEM* RIGHT FOOT TOE NUMBNESS
1%
SURGERY* RIGHT INGUINAL HERNIA REPAIR
1%
SWOLLEN ANKLES (PERIPHERAL EDEMA)
1%
TOOTH INFECTION -> ROOT CANAL
1%
VISION FLOATERS, RIGHT EYE
1%
SEASONAL ALLERGIES
1%
STOMACH FLU
1%
RASH RIGHT CHEEK
1%
RESPIRATORY SINUSITIS
1%
SINUS CONGESTION SINUSITIS
1%
RESPIRATORY INFECTION, BRONCHITIS
1%
RESPIRATORY ASTHMA FLARE-UP, WHEEZING, SOB
1%
RESPIRATORY RHINITIS
1%
STOOL* TARRY
1%
RESPIRATORY CHEST COLD SX, DX WITH PNEUMONIA RIGHT LUNG
1%
RESPIRATORY SOB 6 EPISODES
1%
RESPIRATORY COUGH
1%
RESPIRATORY SHORTNESS OF BREATH 2X
1%
RESPIRATORY UPPER, INFLUENZA
1%
RESPIRATORY DYSPNEA ON EXERTION
1%
SPINNING
1%
SURGERY* PROSTATE RESTRUCTURING-ELECTIVE
1%
VISION CATARACTS, "FLASHING LIGHT"
1%
RESPIRATORY BRONCHIAL ASTHMA
1%
STOOL* LOOSE, 2-3 DAYS/WEEK
1%
RESPIRATORY CHEST CRX, PNEUMONIA RIGHT LUNG
1%
SINUS INFECTION
1%
VISION BLURRED
1%
VISION SUB-CONJUNCTIVAL HEMMORHAGE
1%
WEIGHT LOSS >5%
1%
STOOL* SOFT WITH ABDOMINAL CRAMPS
1%
SURGERY* CABG WOUNDS (CORONARY ARTERY BYPASS GRAFT)
1%
WEAKNESS
1%
STOOL* LOOSER
1%
SUBCONJUNCTIVAL HEMORRHAGE
1%
ROSACASE
1%
SERUM GLUCOSE
1%
SHINGLES
1%
SINUSITIS
1%
SORE THROAT, MUCUS/COUGH
1%
SPRAINED ANKLE
1%
VERTIGO POSITIONAL
1%
SURGERY* HERNIA
1%
SURGERY* TURP/HOSPITAL
1%
SWELLING PERIPHERAL EDEMA
1%
TINNITUS INCREASED, LEFT EAR
1%
WEIGHT LOSS DURING RUN-IN PERIOD
1%
HOSPITALIZATION VAGINAL BLEEDING TOTAL HYSTERECTOMY
1%
PNEUMONIA; POSSIBLE COPD EXACERBATION
1%
BLEEDING IN EYE FROM THORN
1%
INCREASE FLATULENCE
1%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA
1%
ORAL* LESION
1%
RESPIRATORY SHORT OF BREATH
1%
STOOL* HIGHER FREQUENCY
1%
STOOL* LOOSE
1%
WEIGHT LOSS DIETING
1%
VOMITING NAUSEA AND VOMITING
1%
PAIN* RIGHT SIDED PAIN AFTER EXERCISE
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%
HIP BURSITIS
1%
INCREASED FLATULENCE; ANAL INCONTINENCE
1%
INCREASED FREQUENCY OF DROPPING ITEMS
1%
INFECTION* BLADDER INFECTION
1%
INFECTION* ESOPHAGITIS
1%
INFECTION* VAGINAL YEAST
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* 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%
PERIPHERAL NERVOUS SYSTEM* PARESTHESIA L/HAND NUMBNESS
1%
TOOTH ABCESS
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%
HEARING SLIGHT LOSS
1%
HYPERGLICEMIA
1%
HYPERTENSION RETURNED
1%
HYPERTENSION SUSPECT OCULAR HYPERTENSION
1%
INCREASE "BURPING"
1%
INCREASED ALT
1%
INFECTION* INFECTED SCROTAL CYST
1%
PAIN* LEFT ANKLE
1%
KIDNEY PROBLEMS
1%
KIDNEY PROBLEMS/RENAL-OTHER
1%
KIDNEY STONES
1%
LABS ANEMIA
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 INCREASED CHOLESTEROL
1%
LABS PROTEINURIA
1%
LEG PAIN
1%
LOOSE STOOL
1%
LYMPHADENITIS RIGT NECK
1%
MUSCULOSKELETAL BACK SPASM
1%
MUSCULOSKELETAL FOOT PAIN
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%
NEUROPATHY/SENSORY; TINGLING IN FINGERS
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* ANAL FISTULA
1%
OTHER* ANAL FISTULA, SURG REPAIR
1%
OTHER* ARTHRALGIA LEFT ANKLE
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 ON BACK, DRAINED 10/10/00
1%
OTHER* DECREASED LIBIDO
1%
OTHER* DIABETES
1%
OTHER* DIFFICULTY SWALLOWING(DYSPHAGIA)
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* GENITOURINARY/ VAGINITIS
1%
OTHER* GERD
1%
OTHER* GLAUCOMA
1%
OTHER* GLAUCOMA INCREASED
1%
PAIN* LEFT KNEE
1%
OTHER* HEMOPTISIS
1%
OTHER* HOT AND SWEATY
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* PLANTAR FASCIITIS LEFT FOOT
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* TURP
1%
OTHER* VAGINAL ITCHING
1%
OTHER* WHITE BLOOD CELL COUNT INCREASE
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 KNEE
1%
PAIN* RIGHT LEG PAIN
1%
PAIN* RIGHT SHOULDER BLADE
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* SPINAL STENOSIS
1%
POSSIBLE RENAL CALCULUS (TOOK 1 VICODINE)
1%
PROTRUDING AND TENDER HEMORRHOIDS
1%
RASH BODY AND EXTREMITIES
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 CHRONIC RHINITIS CONTINUES
1%
RESPIRATORY COLD
1%
RESPIRATORY DX WITH BRONCHIAL PNEUMONIA
1%
RT ELBOW FX
1%
SINUS CONGESTION ALLERGIES
1%
SLEEP APNEA
1%
SLIGHT QUEEZY STOMACH
1%
SQUAMOUS CELL REMOVAL
1%
STOMACH PAIN
1%
STOMACH VIRUS (VIRAL GASTROECTERITIS)
1%
UPPER HARD PALATE 1 CM ERYTHEMA W/ ULCER
1%
UPPER RESPIRATORY INFECTION
1%
VISION DISTURBANCE
1%
VISION GLAUCOMA
1%
WOUND INFECT
1%
ABDOMINAL PAIN CRAMPING
1%
GASTRIC REFLUX
1%
LOWBACK PAIN
1%
MUSCULOSKELETAL THIGH CRAMPS BILATERAL
1%
NAUSEA AND BELCHING
1%
NAUSEA POST SURGICAL
1%
ORAL* GUM PAIN
1%
ORAL* INCREASED SALIVA
1%
CARDIAC* CONGESTIVE HEART FAILURE
1%
CARDIAC* FLUID IN LUNGS
1%
CHOLECYSTITIS
1%
ACUTE SHORTNESS OF BREATH R/T CHF, IMPROVED
1%
BROKEN RIGHT TIBIA UNDER KNEE D/T MVA
1%
CARCINOMA PROSTATIC
1%
CHEST PAIN
1%
CEREBRAL INFARCTION
1%
GI BLEED R/T DIVERTICULA
1%
MVA
1%
CHANGE IN HEARING PER AUDIOGRAM
1%
CHEST PAIN WITH EXERTION
1%
PANCREATITIS
1%
COLD
1%
PNEUMONIA
1%
COLD SYMPTOMS COLD X3-4
1%
COLD SYMPTOMS HEAD
1%
COLD SYMPTOMS DX SINUS INFECTION
1%
ABDOMINAL PAIN ABD CRAMPING AND BLOAT
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%
GLUCOSURIA
1%
ASTHMA
1%
GI STOMACH CRAMPS
1%
BLACK STOOLS (THINKS FROM MAALOX)
1%
BLEEDING RECTAL 4 EPISODES BRBPR
1%
BALANCE DISTANCE DISTURBANCE
1%
BLEEDING* HEMATURIA
1%
BLOOD IN STOOL SMALL DOT
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%
CAD
1%
CARDIAC* MYOCARDIAL INFARCTION BY EKG
1%
CARDIAC* HEART PALPITATIONS AND HYPERTENSION
1%
CARDIAC* MILD AORTIC SCLEROSIS
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%
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%
DIZZINESS/VERTIGO
1%
EAR INFECTION
1%
ELECT. BALANCE
1%
ELEVATED BLOOD PRESSURE
1%
HEARING HEARING LOSS - SIGNIFICANT OTHER PERCEPTION
1%
EXCISED MASS
1%
HYPERTENSION MILD/MOD
1%
HEARING OTOTOXICITY
1%
HEARING RIGHT EAR "PLUGGED" X2 EPISODES
1%
FLU INFECTION
1%
FX RT GREAT TOE
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%
HEADACHE PRESSURE
1%
HEADACHE SINUS PAIN
1%
HOT FLASHES
1%
HEARING AUDIOMETRIC CHANGE RIGHT EAR
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%
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 SCIATICA
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* DRY THROAT
1%
OTHER* ARTHRALGIA LEFT SHOULDER
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* 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* 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%
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%
SKIN RASH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Eflornithine and Sulindac)
Arm II (Placebo)
Trial Design
2Treatment groups
Experimental Treatment
Group I: ExpansionExperimental Treatment2 Interventions
The expansion cohort will include up to 40 evaluable patients at a proposed RP2D level of AMXT1501 and DFMO defined by AMXT1501-101A study to further characterize safety at proposed RP2D dose level with repeat dosing, and characterize early anti-tumor activity.
Group II: EscalationExperimental Treatment2 Interventions
Dose escalation of DFMO with AMXT1501 fixed dose will follow a 3 + 3 dose escalation design.
The AMXT 1501 starting dose administered in the first cohort will be 1200mg total daily dose (200 mg capsules; 3 capsules in morning; 3 capsules in evening) along with IV DFMO administered in continuous infusion at 2mL/hr over a 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 cohort.
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 Therapeutics, Inc.
1 Previous Clinical Trials
56 Total Patients Enrolled
Sue Lee, MDStudy ChairAminex Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My guardians have consented to my participation in the study, and I agree to follow the study's procedures.I do not have any other active cancers.I have recovered from side effects of my previous cancer treatments.I can take pills and am willing to use a pump for medicine at home.I agree to use effective birth control during and for 3 months after the study.I have been diagnosed with DIPG or DMG and meet specific study requirements.You have had allergic reactions to a similar type of medicine before.I am 18 years old or older.My cancer cannot be surgically removed, has spread, and standard treatments have failed or are not available.You need to give a sample of the fluid around your brain and spinal cord.I haven't had cancer treatment like radiation, surgery, or chemo in the last 4 weeks.I have not had more than one seizure in the past year.I am 12 years or older and weigh more than 40 kg.My seizures are well-controlled, and I have DIPG or DMG.I am unable or unwilling to follow the study's required procedures.I had treatment for brain metastases over 2 months ago and am stable.Your disease has been confirmed through tissue or cell samples.I have had a serious heart condition in the last 6 months.I have an active liver condition.I have a GI condition or had surgery that may affect drug absorption.I am infected with HIV.I take biotin or supplements with more than 30 µg of biotin daily.You have a disease that can be measured or evaluated using specific criteria.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with DIPG or DMG.Your ability to perform daily activities and tasks.Your disease has been confirmed through imaging tests.My kidney, liver, and bone marrow are functioning well.I am not using any LHRH agonist/antagonist medications.You have a disease that can be measured using specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Escalation
- Group 2: Expansion
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 there any recruitment opportunities for this inquiry at the moment?
"Clinicaltrials.gov reveals that this medical investigation is still accepting participants; the study was posted on August 8th 2022 and revised 4 days ago."
Answered by AI
What is the scope of enrolment for this medical experiment?
"Affirmative. Clinicaltrials.gov attests to this research project being actively enrolled, with an initial posting of August 8th 2022 and a most recent update on August 12th 2022. This study is seeking 56 participants across 1 site."
Answered by AI
What is the prime objective of this experimental investigation?
"Aminex Therapeutics, Inc., the sponsor of this trial, declared that measuring the safety and tolerability of AMXT1501 in combination with IV DFMO over a one year period is its primary outcome. As for secondary objectives, pharmacokinetics (PK) of both substances are to be examined as well their effect on immune-related gene expression signatures and IHC cell phenotype. Furthermore, investigators will assess how levels of polyamines change following administration while also gauging Duration Of Response using RECIST v1.1 criteria."
Answered by AI
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