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PI3K Inhibitor

PROS patients treated with alpelisib for Overgrowth Syndrome

N/A
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 4 months
Awards & highlights
No Placebo-Only Group

Summary

This is a mixed-methods observational study that incorporates both qualitative interviews and quantitative data collection through a web-based longitudinal survey (day 1, months 2 and 4).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Pain Inventory for Adult Self-Report and Adolescent Self-Report
EQ-5D-5L for Adult self-report
EQ-5D-Youth for adolescent Self-Report and Caregiver-Proxy
+5 more
Secondary study objectives
Description of change in HRQoL, symptom severity, and pain as a result of treatment

Side effects data

From 2023 Phase 3 trial • 572 Patients • NCT02437318
62%
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%
Dry mouth
10%
Urinary tract infection
10%
Blood creatinine increased
10%
Gamma-glutamyltransferase increased
10%
Aspartate aminotransferase increased
10%
Cough
8%
Nasopharyngitis
8%
Pain in extremity
8%
Dizziness
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%
Pneumonitis
1%
Pulmonary embolism
1%
Dehydration
1%
Upper gastrointestinal haemorrhage
1%
General physical health deterioration
1%
Cellulitis
1%
Pleural effusion
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PROS patients treated with alpelisibExperimental Treatment1 Intervention
Patients with PROS who receive treatment with alpelisb
Group II: PROS patients not treated with alpelisibExperimental Treatment0 Interventions
Patients with PROS who don't receive treatment with apelisib

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,914 Previous Clinical Trials
4,253,316 Total Patients Enrolled
~17 spots leftby Dec 2025
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.
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