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PI3K Inhibitor

Alpelisib for Carcinoma

Phase 1

Waitlist Available

Led By Pamela Munster, MD

Research Sponsored by Pamela Munster

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new cancer drug, alpelisib, when used with the existing drug carboplatin to treat patients with solid tumors or HPV-positive squamous cell carcinoma that has spread.

Eligible Conditions

Solid Tumors
Tumors
PIK3CA Mutation
Carcinoma
Squamous Cell Carcinoma
Cancer

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

Maximum Tolerated Dose (MTD) (Phase 1)

Overall Response Rate Phase (Phase 2)

Percentage of participant with reported DLT (Phase 1)

+2 more

Secondary outcome measures

Median progression-free survival (Phase 2)

Proportion of participants with abnormal glucose values over time

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

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment4 Interventions

Patients with HPV+ squamous cell carcinoma will be administered the recommended phase 2 dose of Alpelisib and Carboplatin in 21 day cycles until unacceptable toxicity, disease progression or death. At baseline, patients will undergo cross-sectional imaging of the abdomen with HP13C. Participants will wear a glucose monitor for the first two treatment cycles

Group II: Phase 1: Dose EscalationExperimental Treatment4 Interventions

Patients with advanced solid tumors will be adminsitered Alpelisib and Carboplatin in 21 day cycles until unacceptable toxicity, disease progression or death. At baseline, patients will undergo cross-sectional imaging of the abdomen with HP13C. Participants will wear a glucose monitor for the first two treatment cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor (CGM)

2017

Completed Phase 3

~650

Alpelisib

2018

Completed Phase 3

~900

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pamela MunsterLead Sponsor

7 Previous Clinical Trials

181 Total Patients Enrolled

1 Trials studying Carcinoma

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,270 Total Patients Enrolled

49 Trials studying Carcinoma

2,080 Patients Enrolled for Carcinoma

Pamela Munster, MDPrincipal InvestigatorUniversity of California, San Francisco

12 Previous Clinical Trials

487 Total Patients Enrolled

Frequently Asked Questions

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

To what degree is Alpelisib perilous to individuals undergoing treatment?

"As Alpelisib is in the first phase of its clinical trial, there is limited data available regarding safety and efficacy. Thus, it has been assigned a rating of 1 out of 3."

Answered by AI

Are recruitment efforts ongoing for this research endeavor?

"The study's information on clinicaltrials.gov confirms that it is not presently recruiting participants, as the last update was dated October 10th 2022. Nonetheless, there are 4,824 other studies actively enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma

Pamela Munster 2022. "Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05472220.