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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 up to 3 years

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

Melanoma
Oropharyngeal Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Difference in quantitative 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) - measurable index lesions on paired, pre-and post-treatment computed tomography scans (delta change in T)

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 Phospho - human epidermal growth factor receptor 3 (HER3)

+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%

Blood creatinine increased

10%

Urinary tract infection

10%

Gamma-glutamyltransferase increased

10%

Dry mouth

10%

Aspartate aminotransferase increased

10%

Cough

Dizziness

Nasopharyngitis

Pain in extremity

Hypertension

Anaemia

Constipation

Alanine aminotransferase increased

Hypokalaemia

Dyspnoea

Myalgia

Muscle spasms

Insomnia

Lipase increased

Abdominal pain upper

Lymphoedema

Musculoskeletal pain

Erythema

Upper respiratory tract infection

Bone pain

Hot flush

Osteonecrosis of jaw

Acute kidney injury

Pleural effusion

Cellulitis

Upper gastrointestinal haemorrhage

Dehydration

Pneumonitis

Pulmonary embolism

General physical health deterioration

Hypersensitivity

Pneumonia

Hyponatraemia

Muscular weakness

Brain oedema

Renal failure

Erythema multiforme

100%

80%

60%

40%

20%

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

~9850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,264 Total Patients Enrolled

7 Trials studying Melanoma

646 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,660 Total Patients Enrolled

558 Trials studying Melanoma

193,233 Patients Enrolled for Melanoma

Julie BaumanPrincipal InvestigatorThe University of Arizona Medical Center-University Campus

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required qualifications able to take part in this trial right now?

"The clinical trial is still searching for patients, based on the most recent information from clinicaltrials.gov. This information was last edited on 3/7/2022, and the trial was originally posted on 12/14/2018."

Answered by AI