Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
74
Countries
1
Sites
1
Metastatic Colorectal cancer
To compare the effect and toxicity of standard chemotherapy and bevacizumab with the same regimen supplemented with tocotrienol in metastatic colorectal cancer.
Key facts
- Sponsor
- Lillebaelt Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jun 2020 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517075-21-00
- EudraCT number
- 2019-004207-13
- ClinicalTrials.gov
- NCT04245865
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To compare the effect and toxicity of standard chemotherapy and bevacizumab with the same regimen supplemented with tocotrienol in metastatic colorectal cancer.
Conditions and MedDRA coding
Metastatic Colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Histopathologically verified adenocarcinoma of the colon or rectum • Metastatic disease • Planned treatment with FOLFOX or capecitabine combined with bevacizumab • Evaluable disease according to RECIST 1.1 • Performance status 0-2 • Expected survival ≥ 3 months • Patient acceptance to collection of blood samples for translational research • Age ≥ 18 years • Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted. • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): o WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 109/l o Platelet count ≥ 100 x 109/l o Hemoglobin ≥ 6.0 mmol/l o Serum bilirubin ≤ 2.0 x ULN o Serum transaminase ≤ 2.5 x ULN o Serum 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 ≤ 1g. • Written and orally informed consent
Exclusion criteria 1
- • Other active malignant disease within 5 years prior to inclusion in the study. • Other experimental therapy within 28 days prior to treatment initiation. • Underlying medical disease not adequately treated. • Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab. • Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment • Bleeding tumor • Pregnant or breastfeeding women • Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment. • Hypersensitivity to one or more active substances or auxiliary substances
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The rate of progression free patients at six months.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD11524949 · Product
- Active substance
- Tocotrienol
- Pharmaceutical form
- CAPSULES LIQUID FILLED
- Route of administration
- ORAL
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 163800 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SYGEHUS LILLEBAELT
- Paediatric formulation
- No
- Orphan designation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2800 mg/m2 milligram(s)/square meter
- Max total dose
- 33600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 85 mg/m2 milligram(s)/square meter
- Max total dose
- 680 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7.5 mg/Kg milligram(s)/kilogram
- Max total dose
- 60 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 224000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lillebaelt Hospital
- Sponsor organisation
- Lillebaelt Hospital
- Address
- Beriderbakken 4
- City
- Vejle
- Postcode
- 7100
- Country
- Denmark
Scientific contact point
- Organisation
- Lillebaelt Hospital
- Contact name
- Clinical Trial Unit
Public contact point
- Organisation
- Lillebaelt Hospital
- Contact name
- Clinical Trial Unit
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 74 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2020-06-26 | 2020-06-26 | 2024-08-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517075-21-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF all | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bevacizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC calciumfolinate | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC capecitabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC oxaliplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC placebo | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-17 | Denmark | Acceptable 2024-09-26
|
2024-09-27 |