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PI3K Inhibitor
Alpelisib for Overgrowth Spectrum Disorders (EPIK-P3 Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 10-mar-2020 (1 day after epik-p1 data cut-off date) to the day before the first interventional dose of alpelisib is administered in the prospective period of this study (day -1)
Awards & highlights
EPIK-P3 Trial Summary
This trial is testing a new cancer drug for people with PROS. It will assess how well and how safely the drug works over a long period of time.
Who is the study for?
This trial is for pediatric and adult patients with PIK3CA-Related Overgrowth Spectrum (PROS) who were previously in the EPIK-P1 study. They must have taken at least one dose of alpelisib after March 9, 2020, and give informed consent. People can't join if they stopped taking alpelisib due to severe side effects or have certain medical conditions like uncontrolled diabetes.Check my eligibility
What is being tested?
The study is testing the long-term safety and effectiveness of a drug called Alpelisib in treating PROS. It's an open-label Phase II trial where all participants know they're getting Alpelisib, following up on earlier research from the EPIK-P1 study.See study design
What are the potential side effects?
Alpelisib may cause serious skin reactions, high blood sugar levels, lung inflammation (pneumonitis), painful mouth sores (stomatitis), pancreatitis, low platelet counts (thrombocytopenia), kidney issues, liver problems indicated by bilirubin elevation, or heart rhythm changes.
EPIK-P3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ retrospective: from 10-mar-2020 (1 day after epik-p1 data cut-off date) to the day before the first interventional dose of alpelisib is administered in the prospective period of this study (day -1). prospective: from day 1 up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~retrospective: from 10-mar-2020 (1 day after epik-p1 data cut-off date) to the day before the first interventional dose of alpelisib is administered in the prospective period of this study (day -1). prospective: from day 1 up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prospective period only: Proportion of participants with new or worsening grade ≥3 treatment emergent adverse events (AEs)
Secondary outcome measures
Prospective period: Proportion of participants with AEs
Retrospective and prospective period: Incidence of PROS-related symptoms and complications/comorbidities among participants with symptoms and complications/comorbidities.
Retrospective and prospective period: Overall clinical assessment as assessed by the investigator
+5 moreSide effects data
From 2023 Phase 3 trial • 572 Patients • NCT0243731862%
Hyperglycaemia
57%
Diarrhoea
45%
Nausea
35%
Rash
35%
Decreased appetite
26%
Vomiting
26%
Weight decreased
24%
Fatigue
24%
Stomatitis
20%
Asthenia
20%
Alopecia
18%
Mucosal inflammation
18%
Pruritus
17%
Dysgeusia
17%
Headache
15%
Dry skin
14%
Oedema peripheral
14%
Pyrexia
14%
Back pain
13%
Rash maculo-papular
11%
Dyspepsia
11%
Abdominal pain
11%
Arthralgia
10%
Blood creatinine increased
10%
Urinary tract infection
10%
Gamma-glutamyltransferase increased
10%
Dry mouth
10%
Aspartate aminotransferase increased
10%
Cough
8%
Dizziness
8%
Nasopharyngitis
8%
Pain in extremity
8%
Hypertension
8%
Anaemia
8%
Constipation
8%
Alanine aminotransferase increased
8%
Hypokalaemia
8%
Dyspnoea
7%
Myalgia
7%
Muscle spasms
7%
Insomnia
6%
Lipase increased
6%
Abdominal pain upper
5%
Lymphoedema
5%
Musculoskeletal pain
5%
Erythema
4%
Upper respiratory tract infection
4%
Bone pain
3%
Hot flush
2%
Osteonecrosis of jaw
2%
Acute kidney injury
1%
Pleural effusion
1%
Cellulitis
1%
Upper gastrointestinal haemorrhage
1%
Dehydration
1%
Pneumonitis
1%
Pulmonary embolism
1%
General physical health deterioration
1%
Hypersensitivity
1%
Pneumonia
1%
Hyponatraemia
1%
Muscular weakness
1%
Brain oedema
1%
Renal failure
1%
Erythema multiforme
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo qd + Fulvestrant
Alpelisib qd + Fulvestrant
EPIK-P3 Trial Design
1Treatment groups
Experimental Treatment
Group I: AlpelisibExperimental Treatment1 Intervention
All participants will receive alpelisib once a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,351 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped taking alpelisib due to severe side effects or uncontrolled diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Alpelisib
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 we currently enrolling people in this clinical trial?
"Unfortunately, this study is not presently looking for patients that match the given criteria. The trial was first posted on January 27th, 2022 and was last edited on October 21st, 2022. However, there are 2 other trials related to pik3ca-related overgrowth spectrum (pros) and 34 studies concerning Alpelisib that are currently recruiting patients."
Answered by AI
How many total participants are needed for this research project?
"At the moment, this study is not looking for new patients to enroll. The listing was first created on January 27th, 2022 and updated as recently as October 21st, 2022. If you are interested in other trials, there are 2 active studies recruiting participants with pik3ca-related overgrowth spectrum (pros) and 34 Alpelisib studies searching for volunteers."
Answered by AI
Has Alpelisib undergone the process of FDA approval?
"Alpelisib's safety was given a score of 2 because, although there is some data suggesting it is safe, none of the available information supports its efficacy."
Answered by AI
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