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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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