← Back to Search

PI3K Inhibitor

Dose Escalation for Myelodysplastic Syndrome

Phase 1 & 2
Waitlist Available
Led By Ecaterina Dumbrava, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Patients must be 18 years or older.
2. Patients must be willing and able to provide informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.

Who is the study for?
This trial is for patients with advanced breast cancer or melanoma. Participants must have a certain type of tumor and be able to take oral medication. They should not have had previous treatments that conflict with the trial drugs.
What is being tested?
The study is testing the combination of two drugs, Alpelisib and Pembrolizumab, to determine a safe dosage level for patients with metastatic breast cancer or melanoma.
What are the potential side effects?
Possible side effects include high blood sugar levels, skin rash, diarrhea, fatigue, immune-related issues such as thyroid problems or lung inflammation.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Study treatment will be administered on an outpatient basis.
Group II: Dose EscalationExperimental Treatment1 Intervention
Study treatment will be administered on an outpatient basis.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,197 Total Patients Enrolled
Ecaterina Dumbrava, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
~33 spots leftby Aug 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top