Phase I Trial of Defactinib and VS-6766. (NCT03875820) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Trial of Defactinib and VS-6766.
United Kingdom87 participantsStarted 2017-12-12
Plain-language summary
This is a multi-centre, investigator-initiated, dose escalation, Phase I trial of the combination of the FAK inhibitor, Defactinib (VS-6063), and the dual RAF/MEK inhibitor, VS-6766 (RO5126766) in patients with advanced solid tumours. VS-6766 (RO5126766) is the same compound as CH5126766.
There are two parts to this study, the dose escalation phase and the dose expansion phase. In the dose escalation phase, cohorts of 3 to 6 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). This will be followed by a dose expansion phase to further characterise the safety and tolerability and to assess the pharmacodynamic activity of the combination.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Dose escalation:
✓. Predicted life expectancy of at least 12 weeks
✓. World Health Organisation (WHO) performance status of 0 or 1 (Appendix 1)
✓. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
✓. Men and women aged 18 years or over.
✓. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
✓. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
✓. Dose escalation: Measurable disease according to RECIST 1.1 or evaluable disease. All radiology studies must be performed within 28 days prior to registration.
Exclusion criteria
✕. Radiotherapy (except for palliative reasons), endocrine therapy, biological therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) before treatment.
What they're measuring
1
To establish a dose for Phase II evaluation from the maximum tolerated dose of the combination of VS-6766 and Defactinib.
Timeframe: 12 months
2
Measure Adverse Events according to CTCAE v4.0.
Timeframe: 6 months
Trial details
NCT IDNCT03875820
SponsorInstitute of Cancer Research, United Kingdom
✕. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.
✕. Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
✕. Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two medically approved forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) from time of consent, during the trial and for six months afterwards are considered eligible.
✕. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of medically approved contraception \[condom plus spermicide\] during the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
✕. Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered.
✕. Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH.