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Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer

NCT01714765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-11-13

No results posted yet for this study

Summary

When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years.

Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib.

Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive.

This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study.

A maximum of 30 patients will be recruited into this multi centre national trial.

Expansion Cohort:

The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg), where 2 patients experienced a DLT.

A total of 7 assessable patients will be recruited during the expansion phase at the MTD (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability, efficacy, PK and biological end points.

Assessable patients for the expansion cohort are defined as being on the study for a minimum of 6 weeks. Any patients enrolled who are not assessable will be replaced.

Conditions

  • Metastatic Clear Cell Renal Cancer

Interventions

DRUG

Dovitinib

Cohort 0: 200mg, Cohort 1: 300mg, Cohort 2: 300mg, Cohort 3: 400mg, Cohort 4: 500mg. Cohort -1: 100mg

DRUG

Everolimus

Cohort 0: 5mg, Cohort 1: 5mg, Cohort 2: 10mg, Cohort 3: 10mg, Cohort 4: 10mg, Cohort -1: 5mg.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Thomas Powles, MD · Queen Mary Unviersity of London, UK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT01714765 on ClinicalTrials.gov