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How does the genetic make-up of renal cell cancer affect the activity of dovitinib?

Dovitinib In 1st-Line Renal Cell Carcinoma, an Investigation into tumour Gene status and Correlation with Efficacy – 1st exploratory study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000140853
Acronym
DILIGENCE-1
Enrollment
31
Registered
2012-02-01
Start date
2012-03-13
Completion date
2013-05-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main purpose of this study is to find out how useful dovitinib is when given as the initial treatment to participants with advanced kidney cancer, that has spread to other parts of the body. The usefulness of dovitinib will be assessed by: how long the disease is controlled while participants are receiving the drug, the proportion of participants who get a reduction in the size of their tumours and how long participants live (both while on dovitinib and on any subsequent therapy they may receive). If participants have secondary disease in the bones, the study will evaluate how useful dovitinib is in controlling this site of disease. In addition, this study will look for changes in the genetic makeup of tumour cells and see if some of these changes are associated with a benefit from dovitinib. The study will also compare and contrast the genetic changes in the primary tumour cells with cells from secondary tumour specimens, and with cells from tumour specimens taken if a participant’s disease has worsened. The purpose of the latter is to identify possible ways in which the tumour becomes resistant to the study drug.

Interventions

Dovitinib 500 mg taken orally once daily 5 days on / 2 days off, until disease progression

Sponsors

Auckland District Health Board (ADHB)
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Advanced / metastatic renal cell (clear cell) carcinoma FFPE tumour tissue available for gene status analysis ECOG PS = 1 Adequate organ function

Exclusion criteria

Uncontrolled brain metastases Another primary malignancy < 3 years prior to starting study treatment Prior systemic anticancer treatment Uncontrolled hypertension Impaired cardiac function; clinically significant cardiac disease Concurrent severe and/or uncontrolled concomitant medical conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026