CompletedPhase 1

Phase I Trial of VS-6766 Alone and in Combination With Everolimus

United Kingdom104 participantsStarted 2013-06-17

Plain-language summary

In Part I of the study VS-6766 will be given twice weekly or three times per week in treatment cycles of 4 weeks to investigate a safe and tolerable dose of the drug. Once the optimal dosing schedule is defined, the following patients with BRAF, KRAS and/or NRAS mutations will be enrolled: 26 patients with solid tumours (Parts IIA \& IIC) and 10 patients with Multiple Myeloma (Part IIB). Up to 44 patients with solid tumours containing BRAF, KRAS and/or NRAS mutations will take VS-6766 in combination with everolimus (Part IID). Of these, 20 patients will comprise the Part IID dose expansion and will all have KRAS-mutant lung cancer.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years or over
✓. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
✓. Histologically or cytologically proven solid tumours or Multiple Myeloma refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient
✓. Life expectancy of at least 12 weeks
✓. World Health Organisation (WHO) performance status of 0 or 1
✓. Measurable and/or evaluable disease according to RECIST 1.1 for patients with solid tumours or according to IMWG for multiple myeloma patients.
✓. Haematological and biochemical indices within the ranges shown in the protocol. These measurements must be performed within two weeks (Day -14 to Day 1) before the patient is entered into the trial.
✓. Documented presence of RAS-RAF-MEK pathway mutations including BRAF, KRAS and NRAS. In Part IIC at least three patients should have KRAS mutant lung cancer. In Part IID expansion, all 20 patients should have KRAS mutant lung cancer.

Exclusion criteria

What they're measuring

Recommend a phase II dose and dosing schedule for VS-6766, as a single agent and also in combination with everolimus.

Timeframe: In the first cycle of treatment (28-35 days).

Assess the safety and toxicity profile of each schedule of administration of VS-6766 both as a single agent and in combination with everolimus.

Timeframe: Throughout time on trial per patient, estimated to be 6 months.

Trial details

NCT IDNCT02407509

SponsorRoyal Marsden NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-15

View on ClinicalTrials.gov More Solid Tumours trials