Ovarian CancerPhase 2Toco-OvarNCT02399592
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
A Phase 2 study testing Bevacizumab and Tocotrinol in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab and Tocotrinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jul 2019
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
- Prior treatment with at least two different cytostatic regimens including platinum.
- Progression on previous treatment.
- Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
- Age ≥ 18 years.
- Performance stage 0-2.
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- Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- WBC ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 109/l
- Platelet count ≥ 100 * 10^9/l
- Hemoglobin ≥ 6 mmol/l
- Serum bilirubin < 2.0 * ULN
- Serum transaminase ≤ 2.5 * ULN
- Serum creatinine ≤ 1.5 ULN
- Urine dipstick for protein <2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents < 1 g.
- Written informed consent.
Who cannot join
- Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
- Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
- Underlying medical disease not adequately treated (diabetes, cardiac disease).
- Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).
- Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
- Non-healing wounds or fractures.
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- Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.
- Clinically significant cardiovascular disease, including:
- Myocardial infarction or unstable angina within 6 months before start of treatment
- New York heart Association (NYHA) class ≥ 2
- Poorly controlled cardiac arrhythmia despite medication
- Periferal vascular disease grade ≥ 3
- Allergy to the active substance or any of the auxiliary agents
- Bleeding tumor
- Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
- Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Bevacizumab, Tocotrinol
- Keywords
- Platinum resistant
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
10 mg/kg q3w
TocotrinolDrug
300 mg tid
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and Tocotrienol | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Tocotrinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of patients without progression after six months of treatment
Measured: 6 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399592
- Sponsor's protocol ID
- Toco-Ovar
- Acronym
- Toco-Ovar
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2015
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02399592
- Acronym / sponsor ID
- Toco-Ovar / Toco-Ovar
- Conditions
- Ovarian Cancer
- Keywords
- Platinum resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 26 Mar 2015 (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 purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and Tocotrienol | Experimental | Drug: Bevacizumab, Drug: Tocotrinol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
- Prior treatment with at least two different cytostatic regimens including platinum.
- Progression on previous treatment.
- Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
- Age ≥ 18 years.
Key exclusion criteria (16 listed)
- Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
- Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
- Underlying medical disease not adequately treated (diabetes, cardiac disease).
- Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).
- Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
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 |
|---|---|---|
| Bevacizumab10 mg/kg q3w | Drug | Bevacizumab and Tocotrienol |
| Tocotrinol300 mg tid | Drug | Bevacizumab and Tocotrienol |
Primary outcome
Fraction of patients without progression after six months of treatment
Time frame: 6 months after start of treatment
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 30 Nov 2020.
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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.
Anders Jakobsen, DMSc study chair
Department of Oncology, Vejle Hospital
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 Bevacizumab and Tocotrinol in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
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 15 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 30 Nov 2020. 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 Denmark. 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?
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?
Fraction of patients without progression after six months of treatment (time frame: 6 months after start of treatment). 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 30 Nov 2020.