Clinical trial · Interventional
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
NCT02399592CI-TRIAL-00048542Toco-OvarcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Tocotrinol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab and Tocotrienol
- interventionNames
- Drug: Bevacizumab
- Drug: Tocotrinol
Primary outcomes (1)
- measure
- Fraction of patients without progression after six months of treatment
- timeFrame
- 6 months after start of treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.