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PI3K Inhibitor

Alpelisib for Melanoma

Phase 2
Waitlist Available
Led By Julie Bauman
Research Sponsored by University of Arizona
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 baseline up to 28 days
Awards & highlights

Study Summary

This trial studies the effectiveness of alpelisib in treating HPV-associated head and neck cancer. Alpelisib works by blocking enzymes needed for cell growth, which may stop the growth of tumor cells.

Eligible Conditions
  • Throat Cancer
  • Oropharyngeal Carcinoma
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 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
Percent Change in Tumor Size (Change in T) in Patients With Genomic PIK3CA Pathway Alteration (PIK3CA Mutation, Amplification, and Fluorescence in Situ Hybridization [FISH] for PTEN Loss)
Quantitative Change in the Sum of Response Evaluation Criteria in Solid Tumors (RECIST) -
Secondary outcome measures
Changes in Pre- and Post-treatment Tumor Levels of E6 and E7 Oncoproteins
Changes in Pre- and Post-treatment Tumor Levels of HER3/PI3K Dimers (Monogram)
Changes in Pre- and Post-treatment Tumor Levels of Human Papillomavirus (HPV) Messenger Ribonucleic Acid (mRNA) (Quantitative Polymerase Chain Reaction [qPCR])
+4 more

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%
Urinary tract infection
10%
Blood creatinine increased
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%
Cellulitis
1%
Pleural effusion
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Alpelisib)Experimental Treatment4 Interventions
Participants receive Alpelisib PO QD for 14-21 days in the absence of disease progression of unacceptable toxicity and then undergo surgery. Participants may receive Alpelisib for up to 28 days if surgery is delayed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
518 Previous Clinical Trials
148,594 Total Patients Enrolled
7 Trials studying Melanoma
646 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,305 Total Patients Enrolled
560 Trials studying Melanoma
195,442 Patients Enrolled for Melanoma
Julie BaumanPrincipal InvestigatorThe University of Arizona Medical Center-University Campus
1 Previous Clinical Trials
21 Total Patients Enrolled
~1 spots leftby Jun 2025
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