Bevacizumab and tocotrienol in relapsed ovarian cancer

Phase 1

• Conditions: Ovarian cancer; MedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000618-13-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-10
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

•Histologically confirmed epithelial ovarian cancer, primary fallopian or primary peritoneal cancer.
•Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
•Progression on previous treatment. Previous treatment with bevacizumab is allowed.
•Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
•Age = 18 years.
•Performance status 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
oWBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l
oPlatelet count = 100 x 10^9/l
oHemoglobin = 6 mmol/l
oSerum bilirubin < 2.0 x ULN
oSerum transaminase = 2.5 x ULN
oSerum creatinine = 1.5 ULN
•Urine dipstick for protein < 2+. If the dipstick shows protein = 2+, 24 hour urine testing must be performed and show protein contents < 1 g.
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Other malignant diseases within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
•Underlying medical disease not adequately treated (diabetes, cardiac disease).
•Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
•Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab.
•Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment.
•Clinical significant cardiovascular disease, including:
oMyocardial infarction or unstable angina within 6 months before start of treatment
oNew York Heart Association (NYHA) class = 2
oPoorly controlled cardiac arrhythmia despite medication
oPeripheral vascular disease grade = 3
•Allergy to 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified