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A Phase I/II Multi-center, Open Label Study of TKI258 Administered Orally on an Intermittent Schedule in Adult Patients With Advanced or Metastatic Renal Cell Cancer (RCC)

Phase 1
18 Years
Not Enrolling
Advanced/ Metastatic Renal Cell Cancer

Thank you

Trial Information

A Phase I/II Multi-center, Open Label Study of TKI258 Administered Orally on an Intermittent Schedule in Adult Patients With Advanced or Metastatic Renal Cell Cancer (RCC)

Inclusion Criteria:

- For phase I, confirmed advanced/ metastatic renal cell carcinoma for which no other
therapeutic options exist.

- For phase II, must have been previously treated with VEGF receptor tyrosine kinase
inhibitor (sunitinib and/or sorafenib).

- For phase II, must have at least one measurable lesion at baseline.

- For both phase I & II, measurable histologically or cytology confirmed progressive
metastatic renal cell carcinoma with predominant clear cell histology (>50%).

- At least 4 weeks must have elapsed since any prior anti-cancer therapy (6 weeks for
nitrosoureas or mitomycin C).

- Must have recovered from adverse events (to grade 1 or less toxicity according to
CTCAE 3.0) due to agents administered more than 28 days earlier.

- Must be eighteen years of age or older

- ECOG performance status 0 or 1.

- Must meet baseline laboratory requirement

- Life expectancy greater than or equal to 12 weeks.

- Signed and witnessed informed consent prior to any screening procedures.

Exclusion Criteria:

- Concurrent therapy with any other investigational agent within 28 days prior to

- Pregnant or breast feeding women.

- Clinically significant cardiac disease (New York Heart Association, Class III or IV)
or impaired cardiac function or clinically significant cardiac diseases.

- Uncontrolled infection.

- Diabetes mellitus with signs of clinically significant peripheral vascular disease.

- Previous pericarditis; clinically significant pleural effusion in the previous 12
months or current ascites requiring two or more interventions/month.

- Known pre-existing clinically significant disorder of the hypothalamic-pituitary
axis, adrenal or thyroid glands.

- Prior acute or chronic pancreatitis of any etiology.

- Acute and chronic liver disease and all chronic liver impairment.

- Malabsorption syndrome or uncontrolled gastrointestinal symptoms (such as nausea,
diarrhea and vomiting) with toxicity greater than NCI CTCAE grade 2.

- Other severe, acutem or chronic medical or psychiatric condition or laboratory
abnormality that may interfere with the interpretation of study results and, in the
judgement of the investigator, would make the subject inappropriate for this study.

- Treatment with any of the medications that have a potential risk of prolonging the QT
interval or inducing Torsades de Points and the treatment cannot be discontinued or
switched to a different medication prior to starting study drug.

- Use of ketoconazole, erythromycin, carbamazapine, phenobarbital, rifampin, phenytoin
and quinidine 2 weeks prior to baseline.

- Major surgery within 28 days prior to starting study drug or who have not recovered
from side effects of such therapy.

- Known diagnosis of HIV infection (HIV testing is not mandatory).

- History of another clinically significant primary malignancy that requires active

- Patients with brain metastases as assessed by radiologic imaging.

- Alcohol or substance abuse disorder.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To determine the MTD of TKI258, administered orally on a 5 days on/2 days off schedule to adult patients with advanced or metastatic RCC whose diseases have progressed despite standard therapy or for whom no standard anticancer therapy exists.

Outcome Time Frame:

at end of phase I

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

July 2012

Related Keywords:

  • Advanced/ Metastatic Renal Cell Cancer
  • Renal Cell Cancer
  • Carcinoma, Renal Cell



Novartis Investigative SiteSpokane, Washington  99202
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteDurham, North Carolina  27710