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

NCT05472220 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-12-27

No results posted yet for this study

Summary

This phase I/II trial tests the safety, side effects, and best dose of alpelisib and whether alpelisib and carboplatin work to shrink tumors in patients with solid tumors or human papillomavirus (HPV) positive squamous cell carcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Alpelisib belongs to a group of medicines called phosphatidylinositol 3-kinase (PI3K) inhibitors. This means alpelisib blocks the activity of the PI3K protein. The PI3K pathway is well known to be involved in tumor cell multiplication and survival. Blocking PI3K may reduce the ability of certain cancers to grow. Carboplatin is an anticancer drug or chemotherapy drug that binds to DNA causing damage that prevents the DNA from replicating, which prevents the cells itself from reproducing. Giving alpelisib and carboplatin may help control the disease in patients with solid tumors and HPV positive squamous cell carcinoma.

Conditions

  • Solid Tumors, Adult
  • PIK3CA Mutation-Related Tumors
  • PIK3CA Mutation
  • Human Papillomavirus-Related Carcinoma
  • HPV-Related Squamous Cell Carcinoma
  • Human Papillomavirus-Related Squamous Cell Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm

Interventions

DRUG

Alpelisib

Given orally

DRUG

Carboplatin

Given IV during imaging

DRUG

Hyperpolarized Carbon-13 (13C) Pyruvate

Given IV

DEVICE

Continuous Glucose Monitor (CGM)

Self-applied devices that sit partially beneath the skin

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Pamela Munster

    lead OTHER

Principal Investigators

  • Pamela Munster, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472220 on ClinicalTrials.gov