AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's… (NCT00390117) | Clinical Trial Compass
CompletedPhase 1
AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma
Canada34 participantsStarted 2007-01-05
Plain-language summary
RATIONALE: AT7519M 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 AT7519M in treating patients with advanced or metastatic solid tumors or refractory 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
* No more than 3 prior regimens for metastatic disease
* Refractory non-Hodgkin's lymphoma
* Clinically or radiologically documented disease
* Patients whose only evidence of disease is tumor marker elevation are not eligible
* No untreated brain or meningeal metastases
* Patients with radiologic or clinical evidence of stable, treated brain metastases are eligible provided they are asymptomatic AND have no requirement for corticosteroids
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 patient has documented liver metastases)
* Potassium normal
* Calcium normal
* Creatine kinase (CK or CPK) ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
* Significant cardiac event (including symptomatic heart failure or angina) within the past 3 months or any cardiac disease that, in the opinion of the investigator, increases the risk for ventricular arrhythmia
* Any history of ventricular arrhythmia, which was sympto…
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 as assessed by NCI CTCAE v.30
Timeframe: from time of 1st dose
2
Safety, tolerability, toxicity profile, and dose-limiting toxicities as assessed by NCI CTCAE v.30
Timeframe: from time of 1st dose
3
Pharmacokinetic profile as measured on days 1, 2, and 4 in course 1
Timeframe: one month
4
Correlation of toxicity profile with pharmacokinetics