← Back to Search

Other

APG-2575 + Palbociclib for Breast Cancer

Phase 1 & 2
Recruiting
Led By Xuemi Sun, MD
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Brain metastases with clinically controlled neurologic symptoms
For patients with breast cancer: Must have histological or cytological confirmation of metastatic carcinoma of the breast with specific tumor molecular characteristics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug, APG-2575, by itself and in combination with another cancer drug, palbociclib. It is for patients with advanced solid tumors or metastatic breast cancer who have progressed or relapsed after first line therapy.

Who is the study for?
This trial is for adults with advanced solid tumors lacking effective standard therapy, or those with specific types of metastatic breast cancer after first line therapy failure. Participants must be over 18, have adequate organ function, and not be pregnant. They should also agree to use contraception and be able to take oral tablets.Check my eligibility
What is being tested?
The study is testing APG-2575 alone in patients with various solid tumors and in combination with Palbociclib for ER+/HER2- metastatic breast cancer patients who didn't respond well to initial treatments. It's an open-label phase Ib/II trial across multiple centers.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to anti-cancer medications such as nausea, fatigue, blood cell count changes, potential infection risks, and possibly unique effects from the new drug APG-2575 or its combination with Palbociclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain cancer has spread but my symptoms are under control.
Select...
My breast cancer has spread and has specific molecular features.
Select...
My cancer has no standard treatment options left, as confirmed by tests.
Select...
I can swallow pills without any issues.
Select...
I am a woman who can have children and have a recent negative pregnancy test.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am in menopause naturally or through treatment.
Select...
I can provide a sample of my tumor for the study, either from previous tests or by undergoing a new biopsy.
Select...
I am 18 years old or older.
Select...
My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLT

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

2Treatment groups
Experimental Treatment
Group I: single armExperimental Treatment1 Intervention
APG2575
Group II: combination armExperimental Treatment2 Interventions
APG2575+palbociclib i
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,269 Total Patients Enrolled
Xuemi Sun, MDPrincipal InvestigatorAscentage Pharma
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

APG-2575 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04946864 — Phase 1 & 2
Breast Cancer Research Study Groups: combination arm, single arm
Breast Cancer Clinical Trial 2023: APG-2575 Highlights & Side Effects. Trial Name: NCT04946864 — Phase 1 & 2
APG-2575 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04946864 — Phase 1 & 2

Frequently Asked Questions

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

Is the upper age limit of participation in this medical trial set at 55 years old?

"According to the prerequisites of this trial, participants must be over eighteen years old and younger than 99."

Answered by AI

What other inquiries have been conducted using APG-2575?

"APG-2575 was first researched in 2012 at Unimed Medical Institute, with 75 studies now concluded. Currently there are 133 functioning trials, many of which take place within the great city of Atlanta, Georgia."

Answered by AI

What is the size of the sample group in this research project?

"Data found on clinicaltrials.gov affirms that this research project is actively enrolling participants; the trial was initially launched on August 13th 2021, and a recent edit occurred on August 12th 2022. Altogether, 65 volunteers need to be sourced from 4 distinct sites."

Answered by AI

What pathologies has APG-2575 been demonstrated to alleviate?

"APG-2575 is an effective therapeutic option for individuals suffering from breast cancer, malignant neoplasms, and postmenopausal symptoms."

Answered by AI

To whom does this clinical trial offer enrollment?

"This research study is accepting 65 individuals impacted by breast cancer, aged between 18 and 99. Eligibility criteria include having measurable or evaluable disease according to RECIST v1.1 standards; prior treatment with a CDK4/6 inhibitor for at least 8 weeks that resulted in progression or recurrence of the condition; being over 60 years old or, if younger than 60, either having undergone a bilateral oophorectomy procedure or medically confirmed ovarian failure as well as cessation of regular menses lasting 12 consecutive months without any other causes, along with serum levels of estradiol and FSH within postmenopausal female reference range"

Answered by AI

How many health facilities are currently administering this experiment?

"This research is taking place at 4 distinct sites; Atlanta, San Antonio, Austin, and other locales. For the sake of reducing travel costs associated with participation in this trial, it is recommended that you opt for a site closest to your residence."

Answered by AI

Are there any remaining opportunities to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this research project, originally listed on August 13th 2021, is actively searching for 65 volunteers to be enrolled across 4 distinct sites."

Answered by AI
~6 spots leftby Jul 2024