Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaPhase 2NCT02644122
SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes
A Phase 2 study testing SF1126 in people with Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, run by Ezra Cohen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
- What is being tested?
- SF1126
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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):
- Peripheral absolute neutrophil count (ANC) 1000/mm3; Note: must be >7 days from use of hematopoietic growth factor or 21 days from pegfilgastrim
- Platelet count 75,000/ mm3 (transfusion independent for >7 days)
- Hemoglobin 8.0 g/dL (may receive transfusions)
- Adequate Renal Function Defined As:
- Serum creatinine ≤ 1.5 x institution's ULN (upper limit of normal), or
- Creatinine clearance 50 ml/min
- Adequate Liver and Pancreatic Function Defined As:
- Total bilirubin 1.5 x upper limit of normal, and
- ALT or AST 5 x upper limit of normal, and
- Albumin 2 g/dL
- Adequate Central Nervous System Function Defined As:
- Subjects with seizure disorder may be enrolled if on anticonvulsants and seizures are well controlled.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- SF1126
- 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
- Medical subject headings
- Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF1126Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SF1126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine ORR
best response of PR or CR observed within 6 months of enrollment
Measured: 6 months
Secondary outcomes (4)
Number of Participants With Treatment-related Adverse Events
Measured: 4 years
To Assess the Effect of SF1126 on Time to Progression.
Measured: 4 years
To Assess the Effect of SF1126 on Overall Survival.
Measured: 4 years
To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezra Cohen
- Sponsor type
- University, hospital or other
- Collaborators
- SignalRX Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Ezra Cohen, University of California, San Diego
- Investigators
- Ezra Cohen, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644122
- Sponsor's protocol ID
- 140904
- Status last verified
- Jun 2018
- First submitted
- 7 Dec 2015
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02644122
- Acronym / sponsor ID
- 140904
- Keywords
- advanced cancer, metastatic cancer, Squamous Cell Carcinoma of the Head and Neck, SCCHN, gene mutation, PIK3R1, PIK3R5 and PIK3AP1, PIK3CG, AKT and mTOR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ezra CohenUniversity, hospital or other
- Collaborators
- SignalRX Pharmaceuticals, Inc.
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SF1126 | Experimental | Drug: SF1126SF1126 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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):
- 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..
Key exclusion criteria (13 listed)
- 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:
- Participation in a trial of an investigational agent within the prior 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF1126 | Drug | SF1126 |
Primary outcome
To Determine ORR
Time frame: 6 months
best response of PR or CR observed within 6 months of enrollment
4 secondary outcomes
Number of Participants With Treatment-related Adverse Events
Time frame: 4 years
To Assess the Effect of SF1126 on Time to Progression.
Time frame: 4 years
To Assess the Effect of SF1126 on Overall Survival.
Time frame: 4 years
To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezra Cohen, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SF1126 in people with Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, run by Ezra Cohen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine ORR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.