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SERD

G1T48 for Breast Carcinoma

Phase 1
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Part 1, postmenopausal women only
For Parts 2 and 3, any menopausal status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat metastatic breast cancer. The drug is given orally, and the study will include 184 patients.

Eligible Conditions
  • Breast Carcinoma
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 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
Dose Limiting Toxicity
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
Recommended Phase 2 dose
Secondary outcome measures
Effect of food on bioavailability of G1T48
Pharmacokinetics of G1T48 and metabolites: Area under Curve - plasma concentration (AUC)
Pharmacokinetics of G1T48 and metabolites: Maximum Plasma Concentration (Cmax)
+4 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Cough
35%
Hyponatremia
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hypercalcemia
31%
Hyperkalemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Dysgeusia
20%
Hyperglycemia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Peripheral sensory neuropathy
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Allergic rhinitis
11%
Hypernatremia
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Tooth infection
7%
Vertigo
7%
Non-cardiac chest pain
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cataract
6%
Knee pain
6%
Cellulitis
6%
Dehydration
6%
Death
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Dry eye
4%
Right arm numbness
4%
Nodule
4%
Watering eyes
4%
Edema trunk
4%
Flu-like symptoms
4%
Vaginal dryness
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Skin bump
4%
Head injury
4%
Memory impairment
4%
Back spasms
4%
Burn
4%
Abdominal pain
4%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Paresthesia
2%
Vaginal itch
2%
Photophobia
2%
Facial nerve disorder
2%
Erythema right breast
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Radiation recall reaction (dermatologic)
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Respiratory syncytial virus (RSV)
2%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Laryngeal inflammation
2%
Groin pain
2%
Bilateral nares sores
2%
Sepsis
2%
Yeast infection
2%
Sinus congestion
2%
Wrist pain
2%
Hyperuricemia
2%
Vaginal infection
2%
Rhinovirus
2%
Myocardial infarction
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Bladder infection
2%
Vaginal itching
2%
Wound infection
2%
Shoulder nodule
2%
Puncture wound
2%
Lung cancer
2%
Sinus tachycardia
2%
Intrascapular pain
2%
Leg pain
2%
Localized edema
2%
Hypermagnesemia
2%
Agitation
2%
Eye lid pain
2%
Blood bilirubin increased
2%
Fever blister
2%
Cold sweats
2%
Fungal toe infection
2%
COPD
2%
Diverticulitis
2%
Paronychia
2%
Activated partial thromboplastin time prolonged
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
2%
Red eye
2%
C. difficile
2%
Hemorrhoids
2%
Pharyngitis
2%
Left hand puncture wound
2%
Vaginal discharge
2%
Nail loss
2%
Oral fissure
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3: Combination Dose Expansion (G1T48+palbociclib)Experimental Treatment2 Interventions
Patients in Part 3 will receive G1T48 once-daily at the dose determined in Part 2 in combination with palbociclib once-daily on Days 1 to 21 of each 28-day cycle.
Group II: Part 2: Monotherapy Dose Expansion (G1T48)Experimental Treatment1 Intervention
Patients in Part 2 will receive G1T48 once-daily at the dose determined in Part 1.
Group III: Part 1: Food Effect Cohort (G1T48)Experimental Treatment1 Intervention
In Part 1, additional G1T48 cohort(s) of 8 patients may be enrolled to assess the effect of different fat content meals (eg, high fat, moderate fat, or low-fat) on the rate and extent of the absorption of G1T48. Patients will receive a single oral dose of G1T48 on Cycle 1 Day -10 and on Cycle 1 Day -3. Patients will begin G1T48 once-daily dosing on Cycle 1 Day 1.
Group IV: Part 1: Dose Escalation (G1T48)Experimental Treatment1 Intervention
Patients in Part 1 will receive a single oral dose of G1T48 on Cycle 1 Day -3 and will begin once-daily dosing on Cycle 1 Day 1. The initial dose cohort shall receive an identified starting dose and subsequent cohorts shall receive higher doses based on the safety and PK data obtained from the previous dose levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G1T48
2018
Completed Phase 1
~110
Palbociclib
2017
Completed Phase 3
~3710

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,184 Total Patients Enrolled
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
1,208 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~16 spots leftby Mar 2025