NL-OMON27160RecruitingNot Applicable
A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC).
Radboud UMC0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Signed (by the patient or legally acceptable representative) and dated Informed Consent Form (ICF).
- •Histological or cytological confirmed, documentation of incurable locally advanced or metastatic, colorectal adenocarcinoma, not amenable for potentially curative treatment (i.e. inoperable).
- •Indication for treatment with TAS-102; progressive on (or intolerant to) therapy including fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)).
- •Evaluable disease by RECIST version 1.1 criteria (see appendix III).
- •Age = 18 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of = 3.
- •Normal 12-lead ECG (clinically insignificant abnormalities permitted).
- •No signs of clinical thyroid abnormalities (suppletion or blocking drugs permitted).
- •Adequate bone marrow function
- •Adequate liver function
- •Albumin higher than 25 g per L
- •Serum creatinine =1.5 x ULN
- •Pregnant or breast-feeding subjects: Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. For fertile men or women of childbearing potential: documented willingness to use a highly effective means of contraception (e.g., hormonal methods [implants, injectables, or combined oral contraceptives], intrauterine devices, sexual abstinence, or vasectomized or surgically sterilized partner). Contraception is necessary for at least 6 months after receiving the study medication.
Exclusion Criteria
- •Exclusion Criteria:
- •Previous treatment with sunitinib and/or TAS-102 for mCRC.
- •Evidence of significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); pulmonary disease (including obstructive pulmonary disease > GOLD 2 and inadequately treated symptomatic bronchospasm), and uncontrolled central nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
- •Extensive prior radiotherapy in the rectum, pelvis or in more than 3 vertebrae in the spine (less than 3 vertebrae are considered a small radiation field and eligibility will be decided on an individual basis from the PI).
- •Poorly controlled hypertension despite adequate blood pressure medication. Blood pressure must be =160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements.
- •Instable seizure disorders requiring anticonvulsant therapy.
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery.
- •Uncontrolled bleeding disorders, and/or active bleeding.
- •Known active bacterial, viral, fungal, mycobacterial, or other infection. (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds.)
- •Known hypersensitivity to sunitinib, TAS-102, or to its excipients.
- •Presence of any significant psychiatric disorder(s) that would interfere with the patient's compliance.
- •Chemotherapy, radiotherapy, or other anti-cancer therapy within the previous 4 weeks; no nitrosoureas or mitomycin C within the previous 6 weeks; no investigational agents within the previous 4 weeks.
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- •Untreated or active central nervous system (CNS) metastases.
- •Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline of > 3 loose stools daily despite medication.
- •Unresolved bowel obstruction
- •Any evidence of a disease or condition that might affect compliance with the protocol or interpretation of the study results or render the patient at high risk from treatment complications.
Investigators
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