Metastatic CarcinomaPhase 1NCT02192346
α-TEA in Advanced Cancer
A Phase 1 study testing 2.4 mg/kg α-TEA, 4.8 mg/kg α-TEA and 8.0 mg/kg α-TEA in people with Metastatic Carcinoma and Metastatic Sarcoma, run by Providence Health & Services at 5 sites in United States.
Trial summary
The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients' blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Carcinoma, Metastatic Sarcoma, Metastatic Lymphoma
- What is being tested?
- 2.4 mg/kg α-TEA, 4.8 mg/kg α-TEA and 8.0 mg/kg α-TEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Aug 2014to 8 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with measurable or evaluable metastatic carcinoma, sarcoma or lymphoma who have malignancy refractory or progressed after therapy and for whom no other standard (non-experimental) therapy exists or who have declined available standard therapy, with potential to induce cure, remission or enhanced survival. Either histologic or cytologic diagnosis is acceptable of the primary cancer, or clinical evidence of metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Age 18 years or above.
- Laboratory values (performed within 28 days prior to enrollment) within protocol specified range.
- Confirmed radiographic and/or serum marker showing cancer progression after at least one systemic therapy for metastatic disease.
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
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- No active bleeding.
- No coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds) at baseline.
- Anticipated lifespan greater than 12 weeks.
- Ability to swallow capsules
- Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on α-TEA and for 4 weeks after the last dose of α-TEA. Men must avoid fathering a child while on α-TEA and for 4 weeks after the last dose of α-TEA.
Who cannot join
- Active serious infection that could affect treatment.
- Coagulopathy or need for anti-coagulation therapy.
- Malabsorbtion state such as ulcerative colitis, previous surgical resection of > 20% of intestine or stomach.
- History of or active atrial fibrilliationfibrillation or supraventricular tachycardia
- Cardiac ejection fraction less than the lower limit of normal on echocardiography
- Right atrial enlargement on echocardiography
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- Active cardiac ischemia. Patients with a history of ischemia ameliorated with stent placement or coronary artery bypass grafting and who have no evidence of ischemia by exercise or physiological stress testing are eligible.
- History of or active congestive heart failure
- Patients with tumor that has invaded vagal nerve, carotid bodies, mediastinal structures, pericardium or myocardium.
- Abnormal thyroid function, or euthyroid, but are on medication for thyroid disorders
- Need for chronic high dose maintenance oral steroids. Stable treatment with prednisone ≤ 10 mg daily (or a biologically-equivalent dose of another steroid) is allowed. Patients who require brief courses of steroids to manage allergic reaction to intravenous contrast used in radiographic studies are eligible. Patients requiring steroids for management of CNS metastatic disease are not eligible.
- Surgery or severe trauma within 4 weeks of study entry (minimally invasive procedures acceptable).
- Active brain metastatic disease. Patients with brain metastases who have been treated with surgery, gamma-knife radiosurgery or radiation and no radiographic progression for at least 4 weeks and off steroids are eligible.
- Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
- Vitamin E supplements
- QTc greater than 450 msec at baseline (calculated using Bazett's formula), sick-sinus syndrome or other active cardiac disease.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Providence Oncology & Hematology Care Clinic- Southeast
Clackamas, Oregon, 97015
Providence Oncology & Hematoloty Care Clinic- Newberg
Newberg, Oregon, 97132
Providence Oncology & Hematology Care Clinic- Willamette Falls
Oregon City, Oregon, 97045
Providence Oncology & Hematology Care Clinic- Eastside
Portland, Oregon, 97213
Providence Oncology & Hematology Care Clinic- Westside
Portland, Oregon, 97225
About this study
Official title: Phase I Study of Alpha-tocopheryloxyacetic Acid (α-TEA) in Patients With Advanced Cancer
The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients' blood.
Additional goals of this study are to monitor the effect on tumors, to check for specific immune cells circulating in the blood, and to see if there are certain features of tumors that make it possible to predict the response to α-TEA.
Read the detailed description
This is a dose-escalation study in which doses ranging from 2.4 mg/kg to 26.8 mg/kg of α-TEA will be tested.
The main clinical objectives of this phase I two-stage dose-escalation trial will be to characterize α-TEA related toxicity, determine the maximum tolerated dose, and pharmacokinetics of α-TEA in humans. Tumor response and exploratory immunological monitoring will also be performed. Specifically, we will determine the frequency of circulating peripheral T cell subset populations including CD4+, CD8+ T cells and their activation status (central memory, effector cells) and regulatory T cells (CD4/CD25/Foxp3). Exploratory monitoring to assess tumor apoptosis and serum cytokine levels will also be performed to gain additional insight on the influence of α-TEA on the immune response and tumor. An assessment of the immunoscore in patients with tumor amenable to biopsy will also provide hypothesis-generating data on the influence of α-TEA on the tumor microenvironment.
- Being tested
- 2.4 mg/kg α-TEA, 4.8 mg/kg α-TEA, 8.0 mg/kg α-TEA, 9.6 mg/kg α-TEA, 12 mg/kg α-TEA
- Keywords
- metastatic, refractory, progressive
- Medical subject headings
- Carcinoma, Sarcoma, Lymphoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.4 mg/kg α-TEADrug
Patients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.
4.8 mg/kg α-TEADrug
Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.
8.0 mg/kg α-TEADrug
Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.
9.6 mg/kg α-TEADrug
Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.
12 mg/kg α-TEADrug
Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.
16.8 mg/kg α-TEADrug
Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.
19.2 mg/kg α-TEADrug
Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.
22.3 mg/kg α-TEADrug
Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.
26.8 mg/kg α-TEADrug
Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 2.4 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 2.4 mg/kg α-TEA |
| 4.8 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 4.8 mg/kg α-TEA |
| 8.0 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 8.0 mg/kg α-TEA |
| 9.6 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 9.6 mg/kg α-TEA |
| 12 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 12 mg/kg α-TEA |
| 16.8 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 16.8 mg/kg α-TEA |
| 19.2 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 19.2 mg/kg α-TEA |
| 22.3 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 22.3 mg/kg α-TEA |
| 26.8 mg/kg α-TEA | Experimental | Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle. Receives: Drug: 26.8 mg/kg α-TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Patients are seen in clinic 7 times over a 28-day period. Patients will have 6 physical exams and meet with a research nurse 5 times for evaluation of any potential drug-related toxicities. In addition, blood will be drawn 7 times for complete blood counts and metabolic panel to check for hematological toxicities. After 28 days, a review of all safety data will determine whether the dose will be increased for subsequent patients.
Measured: 28 Days
Secondary outcomes (2)
Number of Adverse Events Possibly Caused by α-TEA
Patients are seen in clinic 7 times over a 28-day period. Patients will have 6 physical exams and meet with a research nurse 5 times for evaluation of any potential drug-related toxicities. In addition, blood will be drawn 7 times for complete blood counts and metabolic panel to check for hematological toxicities. This information will be used to identify toxicities of α-TEA and characterize the safety profile.
Measured: 28 days
Blood serum levels of α-TEA
Patients will have 11 blood draws over 28 days for evaluation of pharmacokinetics. High-performance liquid chromatography (HPLC) and mass spectrometry detection (MSD) will be used to determine serum drug levels of α-TEA using blood samples collected just before the first dose of α-TEA and 1, 4, 8, and 24 hours after the first dose. Additional samples will be drawn just before the α-TEA dose on Days 2, 5, 8, 15, 22, and 29.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start4 Aug 2014
- Primary completion11 Dec 2017
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, MD, Principal investigator, Providence Cancer Center, Earle A. Chiles Reserach Institute at the Robert W. Franz Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192346
- Sponsor's protocol ID
- 14-043A
- Status last verified
- Aug 2018
- First submitted
- 13 Jul 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Alpha-tocopheryloxyacetic Acid (α-TEA) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02192346
- Acronym / sponsor ID
- 14-043A
- Keywords
- metastatic, refractory, progressive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients' blood.
Additional goals of this study are to monitor the effect on tumors, to check for specific immune cells circulating in the blood, and to see if there are certain features of tumors that make it possible to predict the response to α-TEA.
Detailed description
This is a dose-escalation study in which doses ranging from 2.4 mg/kg to 26.8 mg/kg of α-TEA will be tested.
The main clinical objectives of this phase I two-stage dose-escalation trial will be to characterize α-TEA related toxicity, determine the maximum tolerated dose, and pharmacokinetics of α-TEA in humans. Tumor response and exploratory immunological monitoring will also be performed. Specifically, we will determine the frequency of circulating peripheral T cell subset populations including CD4+, CD8+ T cells and their activation status (central memory, effector cells) and regulatory T cells (CD4/CD25/Foxp3). Exploratory monitoring to assess tumor apoptosis and serum cytokine levels will also be performed to gain additional insight on the influence of α-TEA on the immune response and tumor. An assessment of the immunoscore in patients with tumor amenable to biopsy will also provide hypothesis-generating data on the influence of α-TEA on the tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 2.4 mg/kg α-TEA | Experimental | Drug: 2.4 mg/kg α-TEAPatients will receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle. |
| 4.8 mg/kg α-TEA | Experimental | Drug: 4.8 mg/kg α-TEAPatients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle. |
| 8.0 mg/kg α-TEA | Experimental | Drug: 8.0 mg/kg α-TEAPatients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle. |
| 9.6 mg/kg α-TEA | Experimental | Drug: 9.6 mg/kg α-TEAPatients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle. |
| 12 mg/kg α-TEA | Experimental | Drug: 12 mg/kg α-TEAPatients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle. |
| 16.8 mg/kg α-TEA | Experimental | Drug: 16.8 mg/kg α-TEAPatients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle. |
| 19.2 mg/kg α-TEA | Experimental | Drug: 19.2 mg/kg α-TEAPatients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle. |
| 22.3 mg/kg α-TEA | Experimental | Drug: 22.3 mg/kg α-TEAPatients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle. |
| 26.8 mg/kg α-TEA | Experimental | Drug: 26.8 mg/kg α-TEAPatients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with measurable or evaluable metastatic carcinoma, sarcoma or lymphoma who have malignancy refractory or progressed after therapy and for whom no other standard (non-experimental) therapy exists or who have declined available standard therapy, with potential to induce cure, remission or enhanced survival. Either histologic or cytologic diagnosis is acceptable of the primary cancer, or clinical evidence of metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Age 18 years or above.
- Laboratory values (performed within 28 days prior to enrollment) within protocol specified range.
- Confirmed radiographic and/or serum marker showing cancer progression after at least one systemic therapy for metastatic disease.
Key exclusion criteria (16 listed)
- Active serious infection that could affect treatment.
- Coagulopathy or need for anti-coagulation therapy.
- Malabsorbtion state such as ulcerative colitis, previous surgical resection of > 20% of intestine or stomach.
- History of or active atrial fibrilliationfibrillation or supraventricular tachycardia
- Cardiac ejection fraction less than the lower limit of normal on echocardiography
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 |
|---|---|---|
| 2.4 mg/kg α-TEAPatients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 2.4 mg/kg α-TEA |
| 4.8 mg/kg α-TEAPatients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 4.8 mg/kg α-TEA |
| 8.0 mg/kg α-TEAPatients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 8.0 mg/kg α-TEA |
| 9.6 mg/kg α-TEAPatients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 9.6 mg/kg α-TEA |
| 12 mg/kg α-TEAPatients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 12 mg/kg α-TEA |
| 16.8 mg/kg α-TEAPatients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 16.8 mg/kg α-TEA |
| 19.2 mg/kg α-TEAPatients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 19.2 mg/kg α-TEA |
| 22.3 mg/kg α-TEAPatients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 22.3 mg/kg α-TEA |
| 26.8 mg/kg α-TEAPatients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle. | Drug | 26.8 mg/kg α-TEA |
Primary outcome
Number of Participants with Adverse Events
Time frame: 28 Days
Patients are seen in clinic 7 times over a 28-day period. Patients will have 6 physical exams and meet with a research nurse 5 times for evaluation of any potential drug-related toxicities. In addition, blood will be drawn 7 times for complete blood counts and metabolic panel to check for hematological toxicities. After 28 days, a review of all safety data will determine whether the dose will be increased for subsequent patients.
2 secondary outcomes
Number of Adverse Events Possibly Caused by α-TEA
Time frame: 28 days
Blood serum levels of α-TEA
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brendan Curti, MD principal investigator
Providence Cancer Center, Earle A. Chiles Reserach Institute at the Robert W. Franz Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2.4 mg/kg α-TEA, 4.8 mg/kg α-TEA and 8.0 mg/kg α-TEA in people with Metastatic Carcinoma and Metastatic Sarcoma, run by Providence Health & Services at 5 sites 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 11 inclusion and 16 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: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events (time frame: 28 Days). 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 17 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.