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

NCT02407509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

VS-6766

DRUG

Everolimus

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • Verastem, Inc.

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Udai Banerji, MBBS, PhD · The Institute of Cancer Research, Royal Marsden NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-17
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02407509 on ClinicalTrials.gov