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Squamous Cell Carcinoma of Head and Neck

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Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Metastatic Squamous Neck Cancer With Occult Primary

SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.

SF1126

Ezra Cohen, MD

The purpose of this study is to test the good and bad effects of an experimental drug called SF1126. This drug is being tested in patients whose cancer has not been controlled by available standard therapies and who have certain genes in their tumor.

SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K). PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and metastasize. PI3K also has an important role in the development of blood vessels that are required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals, Inc. It is considered an experimental drug because it is not approved by the FDA for any disease treatment.

SignalRx Pharmaceuticals has developed a pan isoform specific PI-3 inhibitor called SF1126 to treat patients with advanced or metastatic cancer. SF1126 is a conjugate that contains two components: SF1101 (the active drug) and SF1174 (an inactive tetrapeptide RGD targeting moiety)

Both components of SF1126 play key roles in the activity of the drug. SF1101 is a selective inhibitor of certain members of the phosphatidyl inositol 3-kinase (PI-3) family and SF1174 binds selectively to receptors known to be present on neovasculature supporting tumors and on some tumor cells themselves. These components result in a drug designed to be both selective in its activity and targeted in its delivery.

This is an open label Phase II study of SF1126 in adult patients with recurrent or refractory advanced SCCHN with PIK3CA mutation. Treatment cycles (28 days) will consist of SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four cycles and then once weekly for subsequent cycles.

SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

A Phase II Open Label Study of the PI3 Kinase (PI-3) Inhibitor, SF1126, in Patients With Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

best response of PR or CR observed within 6 months of enrollment

SignalRX Pharmaceuticals, Inc.

Ezra Cohen

Professor

SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.

SF1126

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

To Determine ORR

Number of Participants With Treatment-related Adverse Events

To Assess the Effect of SF1126 on Time to Progression.

To Assess the Effect of SF1126 on Overall Survival.

To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Alpelisib is provided as 50 mg and 200 mg film coated tablets as individual patient supply, packaged in bottles. Alpelisib will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. Alpelisib will be administered at a starting dose of 300 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this treatment plan.

alpelisib

Novartis Pharmaceuticals

The purpose of this Cohort Treatment Plan is to allow access to alpelisib for patients diagnosed with HR-positive, HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer

Managed Access Program (MAP) Cohort Treatment Plan CBYL719C2001M to Provide Access to Alpelisib (BYL719) for Patients With HR-positive, HER2-negative Advanced Breast Cancer With Mutated Phosphoinositide 3-kinase Who Progressed on or After AI Treatment

Antineoplastic Agents

Fulvestrant

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Antineoplastic Agents, Hormonal

Hormone Antagonists

In adult patients with advanced solid malignancies whose tumors have an alteration (mutation or amplification) of the PIK3CA gene, and in patients whose tumors are have wild-type PIK3CA gene

In post-menopausal patients with estrogen receptor positive locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene, and in patients whose tumors are have wild-type PIK3CA gene

BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.

BYL719

In adult patients with advanced solid malignancies whose tumors have an alteration (mutation or amplification) of the PIK3CA gene.

Fulvestrant is an estrogen receptor antagonist, administered by monthly intramuscular injection

This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

MTD (or RP2D) of oral BYL719 as single agent and in combination with fulvestrant.

Safety and tolerability: type, intensity, severity and seriousness of adverse events (AE) according to NCI CTCAE v. 4.0.

Objective tumor response rate (ORR), defined as the sum of complete response and partial response as best reported response by RECIST 1.0 criteria (Novartis v2.0 guideline)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes	NCT02644122	Metastatic Squa...	SF1126	18 Years -	University of California, San Diego
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer	NCT04473040	HR+, HER2-, Adv...	alpelisib	18 Years - 99 Years	Novartis
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene	NCT01219699	Advanced Solid ... Estrogen Recept...	BYL719 Fulvestrant	18 Years -	Novartis
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene	NCT01219699	Advanced Solid ... Estrogen Recept...	BYL719 Fulvestrant	18 Years -	Novartis
SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes	NCT02644122	Metastatic Squa...	SF1126	18 Years -	University of California, San Diego
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer	NCT04473040	HR+, HER2-, Adv...	alpelisib	18 Years - 99 Years	Novartis

Spots Global Cancer Trial Database for pik3ca gene

Every month we try and update this database with for pik3ca gene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pik3ca gene

Every month we try and update this database with for pik3ca gene cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pik3ca gene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.