Aurora Kinase Inhibitor AT9283 in Treating Patients With Advanced or Metastatic Solid Tumors or N… (NCT00443976) | Clinical Trial Compass
CompletedPhase 1
Aurora Kinase Inhibitor AT9283 in Treating Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma
Canada35 participantsStarted 2007-01-30
Plain-language summary
RATIONALE: Aurora kinase inhibitor AT9283 (AT9283) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in treating patients with advanced or metastatic solid tumors or non-Hodgkin's lymphoma.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Advanced and/or metastatic solid tumor
* Advanced or metastatic non-Hodgkin's lymphoma refractory to standard therapy
* Clinically or radiologically documented disease
* No tumor marker elevation as only evidence of disease
* No untreated brain or meningeal metastases
* Treated and stable brain metastases allowed provided they are asymptomatic and do not require steroids
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Bilirubin normal
* ALT and AST ≤ 2 times ULN (≤5 times ULN if liver metastases are present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use two effective methods of contraception
* No untreated or uncontrolled hypertension, cardiovascular conditions, or symptomatic cardiac dysfunction
* No active or uncontrolled infections
* No serious illness or medical condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior major surgery and recovered
* At least 3 weeks since prior palliative radiotherapy and recovered
* Low-dose, nonmyelosuppressive radiotherapy may be allowed
* At least 3 weeks since prior chemotherapy for solid tumors and recovered
* No more than 2 prior cytotoxic chemotherapy regimens fo…
What they're measuring
1
Maximum tolerated dose of Aurora kinase inhibitor AT9283 (AT9283)
Timeframe: 1 year
2
Recommended phase II dose of AT9283
Timeframe: 1 year
3
Safety, tolerability, toxicity profile, and dose-limiting toxicity of AT9283