Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous… (NCT05472220) | Clinical Trial Compass
WithdrawnPhase 1
Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma
Stopped: Sponsor funding
0Started 2022-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements. Written informed consent obtained prior to any screening procedures.
. Age \>= 18 years.
. Dose escalation-
. Any locally advanced or metastatic solid tumor malignancy with no curative treatment options available.
. Dose expansion- a. HPV-associated locally advanced or metastatic platinum-resistant squamous cell carcinoma with no treatments available known to confer clinical benefit. If patients enrolled to the dose expansion have alternative therapies available known to confer clinical benefit, patients will be informed of these therapies in the informed consent.
. Patients may have received any number of lines of prior systemic therapy for locally advanced/metastatic disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) (Phase 1)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
2
Recommended Phase 2 Dose (Phase 1)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
3
Percentage of participant with reported DLT (Phase 1)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
4
Percentage of participants with treatment-related adverse events
. Eastern Cooperative Oncology Group performance status \<=1.
. Patient has adequate bone marrow and organ function as defined by the following laboratory values- a. Absolute neutrophil count (ANC) \>= 1.0 x 109/L. b. Platelet count \>= 100 x 109/L. c. Hemoglobin \>= 9.0 g/dL. d. Potassium within normal limits, or corrected with supplements e. International Normalized Ratio (INR) \<=1.5 f. Creatinine clearance \>= 35 mL/min using Cockcroft-Gault formula. g. Total serum bilirubin \<= 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin \<= 3 x ULN or direct bilirubin \<= 1.5 x ULN).
Exclusion criteria
. Prior treatment with PI3K-inhibitor.
. Prior known hypersensitivity to any of the excipients of alpelisib.
. Known allergic reaction or poor tolerability to carboplatin.
. Patients with uncontrolled central nervous system (CNS) metastatic involvement. However, patients with metastatic CNS tumors may participate in this study if the patient is-
. \> 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment.
. Clinically stable with respect to the CNS tumor at the time of screening.
. Not receiving steroid therapy.
. Not receiving anti-convulsive medications that were started for brain metastases.