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

NCT02644122 | Terminated Phase 2 Results DMC

• 1 other identifier: 140904
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma

Keywords

advanced cancer; metastatic cancer; Squamous Cell Carcinoma of the Head and Neck; SCCHN; gene mutation; PIK3R1, PIK3R5 and PIK3AP1; PIK3CG; AKT and mTOR; PIK3CA gene; PI-3 kinase inhibitor; PI-3 kinase pathway genes

Outcome Measures

Primary Outcomes (1)

• To Determine ORR

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

  6 months

Secondary Outcomes (4)

• Number of Participants With Treatment-related Adverse Events

  4 years

• To Assess the Effect of SF1126 on Time to Progression.

  4 years

• To Assess the Effect of SF1126 on Overall Survival.

  4 years

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

  4 years

Study Arms (1)

SF1126

EXPERIMENTAL

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.

Drug: SF1126

Interventions

SF1126 DRUG

SF1126

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of recurrent or metastatic SCCHN or any site except lip, thyroid, salivary gland, or nasopharynx.
• No known FDA-approved therapy available that's expected to prolong survival by greater than 3 months.
• Tumors with at least one of the following known mutations in the PI-3K signaling pathway, via assays performed in a CLIA-approved setting (Foundation Medicine FoundationOne test will be used. This assay uses a cut-off of 5% allele fraction for mutations. Allele fraction will be requested on each sample):
• PIK3CA,
• PIK3CG,
• PIK3R1, PIK3R5 and PIK3AP1 (regulatory subunits),
• AKT and mTOR, or
• PTEN Note: PIK3CA amplification is not eligible.
• Prior receipt of platinum-containing chemotherapy for recurrent/metastatic disease or a history of progression of disease within 6 months of receiving platinum as part of concurrent chemoradiation.
• Disease must not be amenable to potentially curative treatment..
• Has recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy.
• Myelosuppressive chemotherapy: At least 3 weeks since completion (6 weeks for nitrosourea)
• Biologic (anti-neoplastic agent): At least 14 days since completion of therapy with a biologic agent.
• Radiation (XRT):1 week must have elapsed from prior palliative XRT to non-target lesions.
• Adequate Bone Marrow Function Defined for all subjects (including status post SCT):

You may not qualify if:

• Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks.
• Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac \[including life threatening arrhythmias\], hepatic, or renal disease).
• Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia or long-term radiation toxicity (radiation related toxicity 3 months or greater after radiation exposure).
• Presence of cardiac impairment defined as:
• Prior history of cardiovascular disease including heart failure that meets New York Hearth Association (NYHA) class III and IV definitions; OR
• History of myocardial infarction/active ischemic heart disease within one year of study entry; OR
• Uncontrolled dysrhythmias; OR
• Poorly controlled angina.
• Participation in a trial of an investigational agent within the prior 30 days.
• Pregnant or breast-feeding females.
• History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanomatous skin carcinoma or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for 3 years. Other cases will be reviewed and possibly allowed if discussed with and approved by the Principal Investigator.
• Patients receiving therapeutic doses of warfarin.
• Blood pressure greater than 170/90 or two standard deviations from normal based on age and weight nomogram on three separate measurements.

Sponsors & Collaborators

• Ezra Cohen: lead
• SignalRX Pharmaceuticals, Inc.: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck; Hereditary Sensory and Autonomic Neuropathies

Interventions

SF 1126

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Ezra Cohen, MD
• Organization: University of California, San Diego

ecohen@ucsd.edu

(858)822-5800

Study Officials

• Ezra Cohen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 31, 2015
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 11, 2018
• Results First Posted: June 11, 2018

Record last verified: 2018-06

Locations

US (1)