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PI3K Inhibitor

PROS patients treated with alpelisib for Overgrowth Syndrome

N/A
Recruiting
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

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

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

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
2,874 Previous Clinical Trials
4,199,931 Total Patients Enrolled
~18 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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